QUALITY ASSURANCE TERMINOLOGY AND DEFINITIONS

The standard operating procedure (SOP) is to provide a brief introduction about the specific terminology/definition which are used across all SOPs/docum

S. No.	Terms	Definition
A
1	Acceptance Criteria	The acceptance criteria are pre-defined and agreed standards, limits or ranges between different parties such as Quality Assurance and Quality Control or Manufacturing and Quality Assurance or suppliers
2	Accuracy of Measurement	Closeness of the agreement between the result of a measurement and a true value of the measurement.
3	Action Level	The action level is a pre-defined and between different parties agreed written level. Once these levels are exceeded, actions must be undertaken. A complete investigation must be carried out and documented accordingly.
4	Active Pharmaceutical Ingredient (API)	An API also called Drug Substance (DS) is any physiologically active substance that is intended for use in a Drug Product. An API is also a substance when used in the manufacturing, processing, or packaging of a drug, becomes an active ingredient or a finished Dosage Form of the Drug.
5	Actual Yield	The quantity that is actually produced at any appropriate phase of manufacture, processing, or packing of a particular API or intermediate
6	Airlock	An airlock is called a room or space with two or more doors that is interposed between two or more rooms. This is usually build in between different class of cleanliness, for the purpose of controlling the air flow and pressure differential between those rooms. An airlock is designed for personnel or goods.
7	Alert Level	The alert level is a pre-defined and between different parties agreed written level. This level should be used to predict an action level. Once these levels are exceeded an investigation may not be necessary, but closer attention to the indicator is required.
8	Analytical methods validation	The process by which it is established, by laboratory studies, that the performance characteristics of the method meet the requirements for the intended analytical applications.
9	Approval	Once a country’s regulatory authority (for example, the Food and Drug Administration in the United States) approves a new drug application, the new medicine becomes available for physicians to prescribe. The manufacturing company must continue to submit periodic reports to the regulatory authority, including any cases of adverse reactions and appropriate quality control records. For some medicines, the regulatory authority may require additional studies to evaluate long-term effects.
10	Approved By	The signature of the person(s) accepting the document or record for conformity to requirements.
11	Artwork	An artwork could be any printing, text illustration, copy, ornamentation or coloring work on a Product’s Packages. This includes also the label, insert, leaflet, carton, shipper, sticker and vignette.
12	Aseptic Technique	Specific practices and procedures performed under carefully controlled conditions with the goal of minimizing contamination by microorganisms.
13	Audit	An audit is a formal review of the GMP and Quality status of an operation, a facility, a process, a service or system versus the applicable standards and directives.
14	Auditee	The Auditee is the organization that is being audited. The Auditee will be responsible for responding in writing to Audit report observations and implementing corrective actions as necessary.
15	Auditor	Can be one or more individual(s) who are responsible to support the Audit coordination, the pre-Audit meeting if applicable, the Audit, the final wrap up and Audit report information.
16	Auditor Lead	Person assigned by Quality Management who is responsible for assembling the Audit team, Leading the Audit coordination, the pre-Audit meeting if applicable, the Audit, the final wrap up, the Audit report information, writing the Audit report and conducting the follow-up. Typically this is the more senior member of the team.
17	Authorized Person	The authorized person in some European countries also called as qualified persons (QP) is the person(s) among key Manufacturing and Quality personnel responsible for GMP compliance and the release of every Batch of final Products.
B
18	Batch (Lot)	A Batch sometimes called Lot is defined as an entity, by either time or quantity or both, of a product that is intended to have a uniform character and quality. A batch must be produced within predefined and specified conditions following a defined manufacturing cycle or process. Or A specific quantity of an intermediate or API intended to have uniform character and quality, within specified limits, and produced according to a single manufacturing order during the same cycle of manufacture. A batch may also mean a specific quantity of material or API processed in one process or series of processes so that it could be expected to be homogenous.
19	Batch Manufacturing Record (BMR)	The Batch Manufacturing Record (BMR) is the necessary quality and GMP documentation for tracing the complete cycle of manufacture of a batch or lot.
20	Batch Number	The batch number is a combination of numbers and/or letters which should uniquely identify a batch or lot. This numbering system must assure that the complete history for the manufacture and distribution is traceable.
21	Batch Packaging Record	A Batch Packaging Record is a document referencing the bulk Product and Packaging Materials used for the process including but not limited the details of In- Process controls.
22	Batch Record Review	The process of reviewing and approving all Pharmaceutical Product Manufacturing and control records is called the Batch Record Review. This includes but is not limited to Packaging and Labelling. The Batch Record review is performed by the Quality Unit to determine compliance with all established approved written procedures before a Batch is released.
23	Batch Release	The batch release is the process performed by the Quality unit of releasing a Batch or lot of Drug Substance / Active Pharmaceutical Ingredient (API) or Drug Product based on a Batch Record Review to the market (distribution).
24	Best Practice	Best Practice systems, procedures and processes that would be considered to meet an optimal level of compliance are often called Best Practice to highlight that these do not only comply with the GMP rules but also are optimal in regard to a robust or lean system or process.
25	Bio-Burden	Bio-Burden is the amount of viable microorganisms on or in a Manufacturing area, Raw Material, Packaging Component, Bulk Product, Intermediate, Semi-Finished or Finished Product.
26	Biologic product	Any virus, therapeutic serum, toxin, antitoxin, or analogous product applicable to the prevention, treatment, or cure of diseases or conditions of human beings.
27	Biologics License Application (BLA)	The Biologics License Application is the equivalent of an NDA for biopharmaceutical and biotechnology products.
28	Brand name drug	A drug that is sold under the unique, trademarked name selected by the manufacturer rather than under its chemical name.
29	Bulk Product	Bulk Product is the Product, which has completed all Manufacturing steps. The Bulk product did not undergo the packaging process yet.
C
30	Calibration	Set of operations that establish, under specified conditions, the relationship between values of quantities indicated by a measuring instrument or measuring system, or values represented by a material measure or a reference material, and the corresponding values realized by standards.
31	CAPA	Corrective and Preventive Action, a written plan describing actions to be taken to address an issue, plan must include implementation steps and target dates.
32	Certificate of Analysis (CoA)	CoA is the listing of testing results found during the analysis of a Sample which was taken by a defined procedure, of a Batch of Drug Product or Drug Substance/Active Pharmaceutical Ingredient, raw material, components etc.
33	Certificate of GMP Conformance	The Certificate of GMP Conformance is a signed document demonstrating that the item was made in conformance with GMPs and all applicable procedures.
34	cGMP	"Current" Good Manufacturing Practice as put forth in various guidelines through the combined efforts of the FDA, U.S. Department of Health and Human Services, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER) and Center for Veterinary Medicine (CVM). These guidelines, without providing specific methodology, identify the expectations of the FDA in regard to the design, construction and operation of facilities intended for the manufacturing, processing, packing or holding of API’s.
35	Change Control	Change Control is process in a formal change control system by which qualified representatives of appropriate disciplines review and approve a change request. The review and approval includes the assessment weather the change request might affect a validated or registered status.
36	Checked By	The person responsible for observing the actual procedure or witnessing performance of the task or performing an independent check to ensure the task was done correctly.
37	Chemical Component	A Chemical Component is defined as any Chemical Substance not mattering if active or inactive, of a defined Quality used in the manufacture of Bulk Materials, Intermediate or Final Product, whether or not it is present in the Finished Product.
38	Chemical reaction	A process that involves a chemical transformation of a starting material or intermediate to form a new compound (e.g., bond formation, oxidation, reduction).
39	Chemistry, Manufacturing and Control Documentation (CMC Documentation)	CMC documentation is the Chemistry, Manufacturing and Control Documentation section of a Drug Substance / Active Pharmaceutical Ingredient (API) or Drug Product registration.
40	CIP	Clean In Place is a method of cleaning installed pipe and equipment without having to dismantle or move the pipe and equipment. However, provisions should be made for partial disassembly or for personnel access for purposes of cleaning validation to facilitate inspection and sampling of inner product surfaces for possible residue or contaminates.
41	Classified Area	A classified area is called a room, suite or plant which is dedicated to a defined category of activity, where the viable and non-viable particulate levels, airflows, number of air changes and pressure differentials are monitored, checked, and tested to specified limits.
42	Clean Area	The clean area is an area with predefined environmental control following the applicable standards of e.g. particulate and microbial contamination. The clean area should be constructed and used reducing the introduction, generation and retention of contaminants within the area.
43	Cleaning agent	Any material used to clean process equipment, utensils, and storage vessels. These may include soaps, detergents, surfactants, alkalis, acids, or other materials, such as organic solvents, if the solvent is specifically used for cleaning and is not a solvent used in the next processing step.
44	Climatic Zone	The climatic zones into which the world is divided based on the prevailing annual climatic Conditions (ICH stability conditions).
45	Clinical	Denotes the symptoms and course of a disease as distinguished from the laboratory findings or anatomical changes.
46	Clinical investigator	Experienced clinical researcher who implements a clinical study protocol with patients.
47	Clinical pharmacologist	One who has undergone training in basic pharmacology of therapeutic agents in the prevention, treatment and control of disease in man.
48	Clinical response	Any response by a patient to therapy. A positive response can be either complete, in which all signs or symptoms of the disease improve or partial, in which at least one half of the signs or symptoms of a disorder improve and no new signs appear.
49	Clinical trial or clinical study	Testing in which preventive, diagnostic, or therapeutic agents are given to a human population under controlled conditions to determine the agents’ safety and effectiveness. This systematic investigation tests the effects of materials or methods, according to a formal study plan (that is, a protocol), usually in subjects having a particular disease or class of diseases. These trials are conducted to satisfy the regulatory requirements to obtain marketing approval for a new drug or for a new indication for a drug previously approved for marketing. In the United States, must be under an approved investigational new drug application, under the guidance of an Institutional Review Board, and in accordance with the Food and Drug Administration’s (FDA) rules on human studies and informed consent of participants. These studies are conducted in three phases: Phase I, Phase II and Phase III.
50	CMO - Contract Manufacturing (CMO)	Organization or a company that carries out the manufacture of marketed or investigational pharmaceutical products for its clients
51	Commissioning	Commissioning can be subdivided into three major activities; installation, operation and performance qualifications. It is a formal, written procedure to the planning, executing and documenting of facility validation. This process may include environmental compliance checks, verification of personnel protection equipment and qualification of containment systems as well as validation of systems related to cGMP regulations.
52	Complaint (product)	A Complaint by a customer is any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a Product (or device) on the market. Or Means any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for   distribution
53	Component	A Component is any ingredient intended which should be used in the manufacture of a drug product or medical device. This includes those that may not appear in such Drug Product or any Packaging Material containing the Product.
54	Computer System	A Computer System is defined as a system including the input of data, electronic processing and the output of information. This information can then be used for reporting or automatic control.
55	Concurrent validation	A subset of prospective validation in which API batches are released for distribution, based on extensive testing, before completion of process validation. Once data from additional batches produced under replicated conditions show uniformity, the process may be considered validated.
56	Confidential Documents	A document is classified as confidential if disclosing certain information in it could be detrimental to the company’s business interests and the information designated is not publicly available.
57	Container/Closure System	The Container/Closure System is defined as the complete package that holds and protects the Product.
58	Contamination	Contamination is defined as the presence of impurities of a chemical or microbiological nature or of foreign matter, into or onto a Material. Or The introduction of impurities of a chemical or microbiological nature, or of foreign matter, into or onto a raw material, intermediate, or API (e.g., occurring during production, sampling, packaging or repackaging, storage or transport).
59	Continuous production	A process in which a material is continuously produced in a step or series of steps. In a continuous process, the batches of raw materials and the process parameters can be statistically, but not absolutely, correlated to the material produced in a given period of time.
60	Contract Research Organization (CRO)	A company that offers clients pharmaceutical research services, including product development and formulation, clinical trial management, laboratory services, and preparation of regulatory submissions.
61	Control Number	Means any distinctive symbols, such as a distinctive combination of letters or numbers, or both, from which the history of the manufacturing, packaging, labeling, and distribution of a unit, lot, or batch of finished product can be determined.
62	Controlled study or controlled trial	Clinical testing in which one group of subjects is used as a standard of comparison to determine the usefulness of a new medical approach. In a controlled study, doctors give the new drug being tested to one group of subjects, called the "treatment group." They give another drug, or no drug, to a second group of people under the same conditions. This group is often called the "control group." Researchers then compare the results of the two groups.
63	Corrective Actions	The corrective action is the action necessary to recover the product / process / material / system, affected by the deviation.
64	Counterfeit Drugs	Counterfeit Drugs are Drugs which are deliberately and fraudulently mislabeled. The same applies for drugs manufactured deliberately and fraudulently with respect to identity and/or source.
65	Critical	Examples for a critical defect are problems in plant, systems or materials which affect the Quality, safety, purity or efficacy of products and/or can lead to health threatening conditions in finished pharmaceutical products or materials.
66	Critical Equipment / Instrumentation	Critical Equipment / Instrumentation is defined as Equipment / Instrumentation used in a Process that has a direct impact on the Quality, safety, purity or efficacy of Final Product, or are stated as such in Regulatory Dossiers.
67	Critical Parameters	Critical Parameters are parameters used in a Process that have a direct impact on the Quality, safety, purity or efficacy of Final Product, or are stated as such in Regulatory Dossiers.
68	Critical process parameters	Process parameters that must be controlled within established operating ranges to ensure that the API or intermediate will meet specifications for quality and purity.
69	Critical process steps	Process steps that must be controlled within established operating ranges to ensure that the API or intermediate will meet specifications for quality and purity.
70	Cross-contamination	A contamination of a material or product with another material or product.
D
71	Decontamination	Under decontamination the action of separating and eliminating contamination is defined. The contaminants might be of chemical and/or microbiological nature.
72	Dedicated Rooms or Facility	Under dedicated rooms or facility a room or suite of rooms or facility are defined with equipment and services used only for the manufacture of one product, or a closely related group of products.
73	Degradation Product	A degradation product is defined as a molecule resulting from a chemical change in the Drug Substance / Active Pharmaceutical Ingredient (API). This might result by the action of e.g. pH, light, temperature or water or by reaction with an Excipient and/or the immediate Container/closure system or if the Drug Substance brought about over time.
74	Design history file	Design history file (DHF) means a compilation of records which describes the design history of a finished device.
75	Design input	Physical and performance requirements of a device that are used as a basis for device design.
76	Design output	Results of a design effort at each design phase and at the end of the total design effort. The finished design output is the basis for the device master record. The total finished design output consists of the device, its packaging and labeling, and the device master record.
77	Design Qualification	The design qualification should provide documented evidence that the design of e.g. a facility, equipment, services or operation is suitable for the intended purpose. This includes also meeting the Quality and GMP requirements.
78	Design review	Documented, comprehensive, systematic examination of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems.
79	Development report	The Development Report is defined as a compilation of all documents as well as the supporting documentation for the development of a product from conception to market
80	Deviation Trending	Deviations must be trended to detect/predict reoccurrence problems and to monitor the effectiveness of the implementation of the corrective actions. The frequency of the trend analysis and reporting must be at least monthly.
81	Deviations / Non-conformance	A Deviation/ Non-conformance is any unplanned event or failure to meet SOPs and/or failure to meet specified limits, which may potentially affect the safety, identity, efficacy, quality, or purity of products or a violation of the cGMP regulations or internal processes and procedures.
82	Device history record (DHR)	Compilation of records containing the production history of a finished device. Device master record (DMS) means a compilation of records containing the procedures and specifications for a finished device.
83	Device master record (DMS)	Means a compilation of records containing the procedures and specifications for a finished device.
84	Distribution	The Distribution is defined as the delivery of an approved finished drug product to authorized sites, wholesalers, distributors or persons which are authorized to deliver drug products to the public.
85	Documentation	Documentation is defined as any procedures, instructions, logbooks, records, raw data, manuals, and policies associated with the development, manufacture, testing, marketing and distribution of a medicinal product or devices required demonstrating compliance with GMP standards and any other applicable worldwide regulatory requirements.
86	Done By	Signature of the person actually doing the operation, test, inspection, calculation, etc., being recorded.
87	Dosage Form	The dosage form is defined as the product form of the finished product e.g. tablet, capsule, aerosol, pre-filled syringe, elixir and suppository, IV, IM, suspension.
88	Dosage strength	Amount of active drug contained in a particular formulation; for example 50, 100, or 500 milligrams.
89	Drug	As defined in US CFR Section 201(g)(1) of the Act means (a) articles that are recognized in the official United States Pharmacopeia, official Homeopathic Pharmacopeia of the United States, or official National Formulary, or any supplement to them; (b) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or other animals; and articles (other than food) intended to affect the structure or any function of the body of humans or other animals.
90	Drug delivery	The process by which a formulated drug is administered to the patient. Traditional methods have been orally or by injection. Newer methods include through the skin by application of a transdermal patch, or across the nasal membrane by administration of a specially formulated nasal spray.
91	Drug interaction	Modification of the effect of one drug by another in a way that diminishes negates or enhances the effectiveness or safety of one or both drugs.
92	Drug Product	A Drug Product is defined as any product that is offered for sale or distribution and administration to human beings or animals for treatment. Examples for treatment might be but is not limited to preventing and diagnosing disease, for anesthesia, for contraception, and for otherwise altering normal physiological functions.
93	Drug Regulatory Affairs (DRA)	The Drug Regulatory Affairs department is the group being responsible for interaction with the regulatory authorities in the registration of Drug Substance / Active Pharmaceutical Ingredient (APIs) and Drug Products.
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94	Eligibility criteria	Key facts about a person’s health that make a patient right, or not right, for a certain research study. Examples of these facts include: a person’s age, what symptoms of the illness he or she has, results of certain laboratory tests, a person’s overall health, and past treatments. Both the "must-have" and the "can’t-have" check lists help doctors get clear research results about whom a new drug will help, not help, or harm.
95	Enantiomers	Compounds with the same molecular formula as the API, which differ in the spatial arrangement of atoms within the molecule and are non-superimposable mirror images.
96	European Medicines Evaluation Agency (EMEA)	The EMEA is an agency, which was created for having a centralized licensing of medicinal Products. This includes administering applications for mutual recognition of medicinal products for the European Union member states.
97	Evaluation of Training	Any attempt to obtain information (feedback) on the effectiveness of a training program and to assess the value of the training in the light of that information.
98	Excipient	An Excipient is defined as any chemical component other than the Drug Substance / active Pharmaceutical Ingredient (API) in a Dosage Form / Drug product. Examples for excipients are e.g. binders, fillers diluents, disintegrants, lubricants, flavors, colors, and sweeteners.
99	Execution	The carrying out of a change to the extent that verification and/or validation activities can commence. The act, or mode or result of performance.
100	Expected yield	The quantity of API or intermediate or the percentage of theoretical yield anticipated at any appropriate phase of production based on data from process development or process validation.
101	Expiry Date or Expiration Date	Expiry Date or Expiration Date is defined as the shelf life of products and therefore the date beyond which the product should no longer be used.
102	Export Certificates	An export certificate is issued by foreign governments to firms. These certificates are applicable for products that are approved or manufactured in one country and exported to another country.
103	External Audits	External Audits are defined as audits conducted by external agencies, both government and client companies
104	Extraneous substance	An impurity arising from any source extraneous to the manufacturing process.
F
105	Facilities	Facilities are commonly defined in GMP environment as room, suite or plant used for the Manufacture of Products.
106	FDA	Food and Drug Administration. The FDA is the heath agency of the United States.
107	FDA Form 481	The FDA Form 481 is the official FDA Form which must filled out by an FDA Investigator to officially request the collecting of a sample at a site.
108	FDA Form 482	The FDA Form 482 is the official FDA notice of Inspection. This document gives the FDA the authority to enter and inspect per Section 704 of the FD&C Act.
109	FDA Form 483	The FDA Form 483 is the official FDA inspectional observation sheet. This document is issued at the end of the inspection by the FDA and lists all significant objectionable findings noted during an inspection.
110	Field Alert	The Flied Alert is a notification to the US FDA of a potential or actual problem with a marketed drug product or device, e.g. OOS within the shelf life during ongoing stability studies a for marketed drug product.
111	Finished Product	Finished Product is defined as a final product that went through all stages of manufacturing, including packaging, and is in its final, labeled primary and secondary packaging. These may be Drug Substances / Active Pharmaceutical Ingredients (API) APIs or Drug Products.
112	First In - First Out	The strategy by which the oldest approved stock of product is distributed first.
113	Functional Specifications	Functional Specifications are commonly understood as the specifications that define functions, standards and permitted tolerances of systems or parts of systems e.g. components such as equipment. Functional Specifications will therefore define the operating capabilities of the equipment.
G
114	Gang-printed labeling	Labeling derived from a sheet of material on which more than one item of labeling is printed.
115	Gap	An indication that there is a potential that a process, procedure, or practice may be incomplete or deficient, and a potential exists that the observation(s) could be cited.
116	Gap Analysis	A review to identify deficiencies or areas of improvement.
117	Generic Drug Product	A generic drug product is an off patent drug product with the same strength and dosage but other brand as the drug product. Not all components must be necessarily identical. Or A broad term for chemically equivalent drugs that are available from multiple manufacturers. Commonly used to refer to products, other than then innovator’s, that are sold under the universal chemical name for the drug.
118	GMP Calibration	Calibration is called the process that verifies that under specified conditions, the relationship between values indicated by an instrument or system for measuring, recording, or controlling meets the corresponding known values of a Reference Standard.
119	GMP Complaint File	The Complaint File is the documented investigational result including any responses to complainant or authority about a complaint from a released product.
120	GMP Document	A GMP documents can be any written record associated with the manufacture and control or distribution of the Drug Substance / Active Pharmaceutical Ingredient (API) or drug product.
121	GMP Training	GMP training is defined as a documented and assessed GMP training that can be both, general GMP/Quality as well as job specific.
122	Good Clinical Practice (GCP)	The Good Clinical Practice (GCP) is applicable for clinical trials and should assure that generated data, results and conclusions are accurate and credible. GLP includes but is not limited to the design, conduct, performance, monitoring, auditing, recording and analyzing of clinical trials.
123	Good Laboratory Practice (GLP)	The Good Laboratory Practices are predefined, common criteria, which should be addressed as a basis for validating results and conclusions generated in pre-clinical laboratory studies. GLP defines a recognized standard for the management of laboratory studies and results that gives transparent and comprehensible evidence of what has been done.
124	Good Manufacturing Practice (GMP)	The Good Manufacturing Practice (GMP) or the current Good Manufacturing Practices (cGMP) are the minimum criteria and expectations to be met to assure that a drug meets the requirements of the regulations as to safety, and has the identity and strength and meets the quality and purity characteristics that it purports or is represented to possess. The GMPs are applicable for e.g. methods, facilities and controls, the manufacture, processing, testing, packaging or holding of a drug.
125	Grit	Grit is one method of determining or specifying a degree of smoothness or surface roughness required. Initially a desired smoothness for the inside or outside of pipe was specified in polish numbers such as #4 or #7. However, this system of specifying surface roughness provided for too broad a range of roughness. Grit numbers have essentially replaced polish numbers in an effort at providing more specific requirements. For example: a #4 polish could vary from an 80 grit to a 150 grit finish; a #7 polish could vary from a 180 grit to a 320 grit finish. The industry is now adopting an even more specific method of determining surface roughness. The surface is specified in micro inches or microns and measured with a profilometer. The surface roughness is measured or specified as either of two arithmetic derivations: Rq – root mean square or Ra – arithmetic mean. In utilizing a quantitative measuring technique, all of the variables inherent in polishing are eliminated. An end user can now specify a specific surface roughness. For example by specifying 25 m in Ra for a surface roughness the vendor now has to determine the best way to achieve that very specific finish requirement.
H
126	Hazard	Potential source of physical injury or damage to the health of people, or damage to property or the environment.
127	HVAC	Acronym that stands for "heating, ventilating, and air conditioning"
128	Hygiene	Practices associated with ensuring good health and cleanliness. Assurance of cleanliness and sanitation in environmentally controlled areas or clean rooms for the manufacture of sterile drug products.
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129	Identified impurity	An impurity for which a structural characterization has been achieved.
130	Immediate Action	An immediate action is the action taken at the time of an occurrence to make the process / product / system / material safe and secure, and/or Contain effects of event, and / or Prevent further deterioration and / or Correct the event.
131	Impurity	Any component of an API that is not the entity defined as the API
132	Impurity profile	A description of the identified and unidentified impurities present in an API.
133	Inactive ingredient	Any component other than an "active ingredient".
134	Informed consent	The process by which patients learn about and document their understanding of the purpose and procedures of a clinical trial and their agreement to participate in that trial.
135	Initiator (Device Change)	The Initiator is the person / department who propose to implement any changes or initiate activities like deviation, change control.
136	In-Process Control (IPC)	In-Process Control is commonly understood as checks being performed during a Production process for the purpose of monitoring and if necessary, to adjust the process to assure that the Product conforms to its specifications. They are usually part of the registration   file.
137	In-Process Materials	In-Process Materials are defined as materials which are only partly manufactured and will undergo further operations before it becomes a final product.
138	Inspection	The process undertaken by an Inspector/Investigator to review the company facilities and/or systems.
139	Inspection Coordinator	A representative of the company, typically the QA Manager, assigned responsibility for preparing for the inspection, escorting the Inspector/Investigator and facilitating the inspection while the Inspector/Investigator is on the company premises.
140	Inspection File	A compilation of documents pertaining to the inspection. This may include, but is not limited to forms and letters from inspecting parties, inspection report, inspection notes, Evidential Materials List, evidential material or reference to location, list of assigned corrective actions, meeting minutes, sample submission forms, and other inspection supported and related materials.
141	Inspection Report	A document issued by the Inspector/Investigator that describes the scope of the inspection and any observations resulting from the inspection.
142	Installation Qualification (IQ)	The Installation Qualification (IQ) is defined as the performed and documented operations to ensure that facilities, utilities, equipment and systems are installed as designed and specified.
143	Instrumentation	Instrumentations are devices and linkages used to control, measure, calibrate, record or alarm a process, equipment or service function.
144	International Conference on Harmonization (ICH)	The international body responsible for harmonizing worldwide regulatory requirements for pharmaceuticals
145	Investigation	An investigation is the systematic process by which an incident is examined to determine: ·         The immediate cause, conditions or situation. ·         The root cause. ·         The overall impact on API, drug product, medical device or material. ·         The need for any action required to prevent reoccurrence. The investigation of the root cause should be understood and documented normally after 30 working days.
146	Investigational New Drug (IND) application	The document that a sponsor (usually a drug company) must submit to the FDA before beginning testing of a new drug on humans. This IND application contains the plans for the clinical for the clinical studies and gives a complete picture of the drug, including its structural formula, animal test results, and manufacturing information. The IND application contains information resulting from several years of research and testing.
147	ISO	International Standards Organization
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148	Label	A label is defined as the product identifier including patient instructions that are placed on the primary container.
149	Labeling	Labeling is defined as the process when a label is put on a product. Or Printed materials that accompany a prescription drug when shipped in interstate commerce.
150	License (Product License)	The license is the registration containing the regulatory requirements for a product, such as Market Application Authorization (MAA) or New Drug Application (NDA).
151	Lifecycle	The term Lifecycle is commonly used in relationship to the entire lifetime of a product or process. This may start from design, development, realization, validation, production, change control, process improvements and re-validation until the product or process ends.
152	Limit of Detection	The term limit of detection is used for the lowest level of analyte that can be detected using a specific method under the required conditions.
153	Limit of Quantitation	The term limit of quantitation is used for the lowest concentration of analyte in a sample that may be determined with acceptable accuracy and precision when the required method is applied.
154	Line Clearance	The term line clearance is used for the documented act of conducting any necessary removal of products and materials from a manufacturing line to prepare the line for the next production (packaging).
155	Line Segregation	The term line segregation describes the usage of a physical separation of lines, usually done with a physical wall or barrier (packaging).
156	Load Pattern	The term load configuration is the pre-defined, documented description of the exact configuration of material or product when entering a lyophilizer or sterilizer (e.g. autoclave).
157	Long Term Stability	The term long term stability describes a stability evaluation of the physical, chemical, biological and microbiological characteristics of a material or product. The long term stability should cover the expected duration of the shelf life that is claimed in the submission and will appear on the Labeling of the product.
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158	Maintenance	The term maintenance is used for a system describing on how to maintain good working order facility, utility, equipment or instruments for their intended use. Maintenance is categorized in planned or preventative maintenance or breakdown maintenance or repair.
159	Major	Examples for a major defect are problems in plant, systems or materials which can affect the Quality, safety, purity or efficacy of Products or which lead to non-health threatening conditions in finished Pharmaceutical Products.
160	Management Audit	The periodic audit of the suitability, adequacy and effectiveness of the Quality System within an organization as performed by Senior Management of the organization.
161	Manufacture	The term manufacture also often referenced as manufacturing describes the complete cycle of manufacture of drug substance / Active Pharmaceutical Ingredient (API) or drug product from start of material purchasing till dispatch for sale or supply purchase of final rug substance / Active Pharmaceutical Ingredient (API) or drug product.
162	Market withdrawal	The removal or correction of a distributed product, which involves a minor violation which would not be subject to any legal action by the health authorities or which involves no violation (e.g. stock rotation practices).
163	Marketing Authorization Application (MAA)	The Marketing Authorization Application is the registration file submitted to the relevant national authorities of EU member states or the EMEA (European Medicines Evaluation Agency) as part of an application to market a new product in the European Union.
164	Master Manufacturing Record	The Master Manufacturing Record is the comprehensive document describing the full manufacturing process for the manufacture of a drug substance or drug product. The process starts with the starting materials, their quantities, to be used, together with a description of the manufacturing operations including details of the In Process Controls (IPC).
165	Material	The term material is used for either raw materials, intermediates or packaging components used in the manufacture of drug substance / Active Pharmaceutical Ingredients (API) and drug products.
166	Measurement Standard	Material measure, measuring instrument, reference material, or measuring system intended to define, realize, conserve, or reproduce a unit or one or more values of a quantity to serve as a reference.
167	Method	A method is a designed way of performing a process, a check-up or a test which must be normally validated under GMP conditions.
168	Minor	Examples for a minor defect are problems that if they are not corrected, would not cause harm to the Product or patient, but indicate minor breaches to GMP rules.
169	Mock Recall	A mock recall is called a simulation of a recall inside a site or company. The intent is to verify the effectiveness of the internal steps in the recall procedure except the notification of any regulatory agency.
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170	New Chemical Entity (NCE)	The designated therapeutic moiety (API) in a dosage form that has not been approved for marketing in the United States (also referred to as a new chemical entity or new drug substance). It may be a complex, simple ester, or salt of a previously approved API.
171	New Drug Application (NDA)	A formal application to the FDA for approval to market a new drug product. When the investigational phase of a drug is completed, the manufacturer gathers together the results of all studies and submits them to the FDA in a New Drug Application. This application is reviewed in detail by a team of reviewers. The purpose of the NDA is to determine whether the drug meets the statutory standards for safety,   effectiveness, labeling and manufacturing.
172	Non-fiber-releasing filter	Any filter which, after any appropriate treatment such as washing or flushing, will not release fibers into the component or drug product that is being filtered. All filters composed of asbestos are deemed to be fiber-releasing filters.
173	Non-viable Particulate	A non-viable particulate is any type of particle, which is not living microorganisms.
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174	Official Standards	Official Standards are commonly reference Standards, which had been provided by a Compendial body, the WHO organization or another certified body.
175	Operational Qualification (OQ)	Operational Qualification (OQ) is the documented verification that the identified system or subsystem performs as intended throughout all operating ranges of pressure and temperature.
176	Out of Specification Results (OOS)	An OOS is a result that fall outside the predefined specifications or acceptance criteria.
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177	Packaging	Packaging is called the process of assembling the Final Product. This act may include but is not limited to filling, capping, labeling, Cartoning and packing.
178	Packaging Components	The term packaging components or packaging material is used for delivery devices, primary packaging Components, secondary packaging components or any other packaging components.
179	Packaging Integrity	The packaging integrity is the assurance that the designed packaging component fulfills the predefined requirements in protecting the product during transportation, storage and handling during the products full self-life.
180	Packing Material	The term Packing Material is used for the non-product contact materials used to hold, protect and ship the primary container.
181	Passivation	A process in which a diluted nitric acid solution is used to remove discoloration from weld areas as well as dissolve and flush out all iron particulates and residue. These deposits may be the result of being improperly cleaned and stored at the mill, the fab shop or the site. In the case of piping systems the process involves circulating the heated nitric acid solution for a period of time followed by a thorough flushing with potable or purified water. A test is then done to determine if free iron can be detected. When the test determines that the system is clear of any contaminants potable or purified water is flushed through the system until the pH and conductivity/resistivity of the effluent water samples are the same as that of the influent.
182	Percentage of theoretical yield	The ratio of the actual yield (at any appropriate phase of the manufacture, processing, or packing of a particular drug product) to the theoretical yield (at the same phase), stated as a percentage.
183	Performance Qualification (PQ)	Performance Qualification (PQ) provides documented evidence that the integrated system or process is capable of consistently producing the intended product in a high quality and safe manner.
184	Personal Training File	The personal training file contains the relevant employee’s documentation on the qualifications, experience, and training/assessment of an individual
185	Pest Control Program	The Pest Control Program is a documented program which should be applied at any warehouse, storage or manufacturing facilities to monitor the presence of rodents, pests, birds and insects with the goal to eliminate the vermin.
186	Pharmaceutical	Referring to pharmacy or medical drugs; any therapeutic product used in medicine. A pharmaceutical is a drug derived from organic or inorganic chemicals and used to treat a wide range of medical conditions.
187	Pharmaceutical Waste	Pharmaceutical Waste is the waste which is generated during the manufacture of Drug Substance / Active Pharmaceutical Ingredient or a Pharmaceutical Product.
188	Pharmacodynamics	The study of drug action primarily in terms of drug structure, site of action, and the biochemical and physiological consequences of the action. pharmacoeconomics: Studies focusing on the total impact of the product or services on the health system. Pharmacoeconomics relies upon several economic methodologies, including cost-benefit, cost-effectiveness and cost-utility analysis.
189	Pharmacokinetics	The study of how the body handles a drug, with particular emphasis on the time required for absorption, duration of action, distribution through the body and method of excretion. Pharmacology: The science that deals with the study of drugs in all aspects, including drugs’ mechanisms of action.
190	Pilot scale	The manufacture of an API on a reduced scale by processes representative of and simulating those to be applied on a larger commercial manufacturing scale.
191	Placebo	Inactive agent without therapeutic value used in controlled studies to determine the efficacy of the potential therapeutic agent against which it is being compared. The placebo is made to look exactly like the therapeutic agent.
192	Potential impurity	An impurity that, from theoretical considerations, may arise from or during manufacture. It may or may not actually appear in the API.
193	Pre-Approval Inspection (PAI)	A Pre-Approval Inspection is an inspection performed by a government regulatory agency such as the FDA in response to an NDA (New Drug Application) or equivalent submission whose objective is to assess the applicant’s attributes against the GMPs and filed documents before final approval of the submitted dossier.
194	Precision	The degree of agreement among independent measurements of a quantity under specified conditions.  Note: The measure of precision is usually expressed in the terms of imprecision and computed as a standard deviation (or a given multiple of it).
195	Preventative Action	The preventive action is the action taken to address the root cause of the deviation and prevent reoccurrence of the event.
196	Preventive Maintenance	The Preventive Maintenance describes all scheduled work done on a routine, predefined basis to maintain facilities, equipment, utilities and devices in good status in order reliably performance.
197	Primary (primacy) Reference Standards	A primary reference standard is an official substance whose characteristics and potency are warranted by a certified body. Or A particular portion, lot or batch of an API or intermediate that has been shown by an extensive set of analytical tests to be of the highest purity. This standard may be purchased from a recognized source or may be prepared by independent synthesis or by further purification of existing production material.
198	Primary Packaging	Defined as either the packaging material used to form a primary container which directly contacts the drug product or the method of placing the drug product into its primary container.
199	Printed packaging components	Printed packaging components are e.g. labels, leaflets, inserts, cartons, etc.
200	Procedure	A procedure is a clear and precise documented description of an activity including the methods to be employed and responsibilities. This might be in many cases a Standard Operating Procedure (SOP).
201	Process Control	The process control are the installed controls helping to manage a process and limiting process variations by observation, analysis, interpretation and action.
202	Process Performance Qualification	Establishing confidence that the process is effective and reproducible.
203	Process Validation	The process validation is the documented evidence that a process will consistently produce a product meeting its predefined acceptance criteria and quality attributes with a high degree of assurance.
204	Product Labeling	Includes product labels, package inserts, information leaflets (clinical), folding cartons, any other product or lot specific printed material which is included on or with the finished product package. Product labeling also includes any materials that provide directions on the preparation, use, administration, and/or the safe and effective use of a Baxter product.
205	Product Performance Qualification	Establishing confidence through appropriate testing that the finished product produced by a specified process meets all release requirements for functionality and safety.
206	Production Scale	The production scale is the scale of a proposed commercial process for the commercial production of Drug Substance / Active Pharmaceutical Ingredient or Drug Product.
207	Prospective Validation	A prospective validation is a validation, which must be completed before a process is used, or before a Product is released to the market.
208	Protocol	A protocol is a reviewed and approved document that clearly indicates the objectives, experimental steps, test parameters and the acceptance criteria to perform a study in a GMP environment.
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209	Qualification	The term Qualification allocates certain limits or restrictions to attributes of equipment, utilities or processes related to its performance. The qualification normally includes Design Qualification (DQ), Installation Qualification (IQ) and Operation Qualification (OQ). Finally, the measurement of those attributes in those ranges for those functions is done in the Performance Qualification (PQ).
210	Qualification Protocol	A Qualification Protocol (QP) is a written plan or procedure stating in sufficient detail how qualification will be achieved. Included are specific qualification requirements for each equipment item, each system requirement, and product requirement. Each protocol should stipulate test parameters as well as decision points on what constitutes   acceptable test results. The written protocols should be based on the associated qualification procedures and should be step-by-step instructions to be used in the field to qualify equipment, instruments, materials, systems and subsystems, and should include data sheets to record critical data.
211	Qualified	The term qualified is used in the content of verification of being capable of providing the required performance, used in reference to personnel, utilities, and equipment.
212	Qualified Inspector	Amneal representative that has the appropriate training, knowledge, experience, and skills to perform audits.
213	Qualified Person	The qualified person (QP) is the person(s) among key Manufacturing and Quality personnel responsible for GMP compliance and the release of every Batch of final Products.
214	Qualified Supplier	A qualified supplier is often defined as an approved supplier which did undergo a program of comparative testing that has demonstrated the ability to consistently supply a material of an acceptable quality level and has demonstrated the reliability of their test results.
215	Quality	The term Quality is used in the GMP environment as the totality of features and characteristics of a product or service that bears on its ability to satisfy stated or implied needs including the conformance to requirements to specifications.
216	Quality Assurance	The Quality Assurance ensures that Product Quality, safety, purity and efficacy is known and effectively controlled.
217	Quality Assurance Unit	The Quality Assurance Unit sets policies, procedures and specifications, audits, reviews, assesses and training including continuous evaluation of the adequacy and effectiveness of the overall quality program, including corrective and preventive measures (CAPA) which are initiated where necessary.
218	Quality Audit	Is a systematic, independent examination of a manufacturer´s quality system that is performed at whether both quality system activities and the results of such activities comply with quality system procedures, that these procedures are implemented effectively, and that these procedures are suitable to achieve quality system objectives.
219	Quality Control	The term Quality Control is used as part of GMP, which is concerned with assessing and measuring specific quality attributes.
220	Quality System	Organizational structure, responsibilities, procedures, processes, and resources for implementing quality management.
221	Quarantine	The term quarantine is used to describe a special status of Materials, Intermediates or Products that are isolated or otherwise withheld from use, pending a decision on their release, rejection, or reprocessing.
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222	Ra (CLA)	Arithmetic mean roughness value. The arithmetical average of all absolute distances of the roughness profile R from the center line within the measuring length lm.
223	Random Sample	A random sample is defined a unit taken from a larger population of such units. In a simple random sample each unit has an equal chance of being included.
224	Raw Data	Raw data in the GMP environment can be defined as any work sheets, records, memoranda, notes or exact copies thereof, that are the result of original observations and activities of a study, or a process, and are necessary for the reconstruction and evaluation of the report of that study or process. Raw data includes e.g. photographs, computer printouts and magnetic media, including dictated observations, and recorded data from automated instruments where applicable.
225	Raw Material	Any ingredient intended for use in the production of APIs. These may include starting materials, process aids, solvents, and reagents. Reagent: A substance, other than a starting material or solvent that is used in the manufacture of an API or intermediate.
226	Reanalysis	Reanalysis is the repetition of some or all conducted analytical testing. This is different than Reanalysis or a Resample.
227	Recall	The product recall is basically the removal of one or more batches of product from the market, thought or known to be in violation of one or more laws or rules in that country with full knowledge of one or more regulatory agencies.
228	Reconciliation	The term reconciliation is used to for performing a comparison between the amount of product or materials theoretically produced or used and the amount actually produced or used.
229	Recovery	Any treatment of materials by a process intended to make them suitable for further use.
230	Reference Standard	A reference standard is defined as any chemical substance or mixture, or analytical standard, or material other than a test substance that is used for the purposes of establishing a basis for comparison with the test substance for known chemical or biological measurement.
231	Regulatory Authority	The Regulatory Authority (Regulatory Body) is a legislatively empowered organization, group, or individual charged with evaluating the compliance profile of a site and/or product as measured against applicable standards.
232	Regulatory Compliance	The term Regulatory Compliance is used for the system within the organization administered by the Quality Assurance Unit to ensure adherence to the applicable Regulatory Requirements
233	Regulatory Requirements	The term Regulatory Requirements is often used for mandates and standards enforced by a government-appointed agency designed to protect the public interest by assuring identity, potency, Quality, purity, safety and efficacy of drugs, devices and components entering into the market place.
234	Regulatory Specifications	For Pharmacopoeia articles, the specifications in the current edition of the pharmacopoeias are those legally recognized and are used by the agencies when determining compliance with the Regulations or the defined limits within which physical, chemical, biological and microbiological test results for a Drug Substance / API (Active Pharmaceutical Ingredient) or a Drug Product should fall when determined by the Regulatory methodology.
235	Release Specification	The release specifications are the specifications which must be met to release a Product. This might be a combination of physical, chemical, biological and microbiological test requirements that determine that a final product is suitable for release.
236	Representative Sample	A representative sample is defined as a sample that is based on rational criteria such as random sampling, and is intended to assure that the sample is representative of the sampled material.
237	Reprocessing	The treatment of all or a part of a batch of product from a defined stage of production with the original process so that it’s quality may be rendered acceptable by one or more additional operations. ICH Q7A defines reprocessing as is introducing an intermediate or Drug Substance…back into the process and repeating appropriate chemical or physical manipulation steps (e.g., distillation, filtration, chromatography or milling) that are part of the established manufacturing process.
238	Resample	A resample is an additional sample taken from the batch of material Resample should only been taken if the original sample used for testing is deemed not representative of the batch or the original sample has been compromised in some manner.
239	Reserve Sample	A reserve sample also called retained sample is a sample being representative of the batch from which it was taken and which is stored over a pre-determined period of time to perform testing if needed against established specifications.
240	Retest Date	The retest date of a material is the date when material must be tested again to assure that the material still meets all specification.
241	Retest Period	The retest period is the timeframe during which the Drug Substance / Active Pharmaceutical Ingredient (API) can be considered to remain within the predefined specification and therefore, acceptable for use.
242	Retesting	Retesting is defined as the conduct of repeating an analytical procedure on a different portion of the same sample.
243	Retrospective Process Validation	A Retrospective Process Validation is a validation of a process which is already in use based upon accumulated historical data’s conformance to predetermined acceptance criteria.
244	Retrospective Qualification	A Retrospective Qualification is qualification of a system already in use based upon accumulated historical data’s conformance to predetermined acceptance criteria.
245	Returned Goods	Any returned finished packaged drug product not associated to a complaint or a recall.
246	Revalidation Process	The term Revalidation Process is used for the description of a repeated validation to provide assurance that changes in the Process or Process environment, whether introduced intentionally or unintentionally do not adversely affect process characteristics and process quality of a validated process.
247	Reviewed by	Signature of the person responsible for reviewing and examining the documentation certifying that the record / protocol / report has been reviewed and found completed and in compliance.
248	Reworking / Rework	The treatment of all or part of a batch of material of unacceptable quality using an approved process other than that used to produce the original. ICH Q7A defines reworking as subjecting an intermediate or Drug Substance (DS=API) that does not conform to standards or specifications to one or more processing steps that are different from the established manufacturing process to obtain [material of] acceptable quality (e.g., re-crystallizing with a different solvent).
249	Risk Management	The systematic use of available information to manage the tasks of identifying hazards and estimating, evaluating, and controlling risk.
250	Risk-benefit ratio	Relation between the risks and benefits of a given treatment or procedure. Institutional review boards located where the study is to take place determine whether the risks in a study are reasonable with respect to the potential benefits. The patient also decides if it is reasonable, in light of the risk-benefit ratio, to take part in the study.
251	Root Cause	Primary source(s) producing the undesirable effect on the product, process, or quality system.
252	Root Cause Analysis	The investigation of the data using various analytical tools to identify the root cause.
253	Rq (RMS)	Root mean square roughness value. (An alternative to Ra.) The RMS value of a profile calculated over a single sampling length, but can be expressed as the mean result of 5 consecutive sampling lengths.
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254	Sampling	Sampling commonly describes the process of taking samples/units of finished material, In-process Material, Raw Material or Components for assessment.
255	Sampling Plan	A sampling plan describes the details of the planed sampling activity e.g. the number of units or quantity of Material that must be collected and the manner in which it is to be collected.
256	Sanitation	The term sanitization in the GMP environment is defined as the hygienic control on production processes as well as personnel, premises, equipment and material handling. This will reduce e.g. the bio-burden to a defined level.
257	Scale-up	The term scale up is often used to describe the increase of a batch size during development of a Drug Substance or Drug Product.
258	Secondary Packaging	Any packaging subsequent to product placement in the primary container or the components of such packaging, such as the labeling, cartoning or case packing.
259	Self Inspection	The term Self Inspection is used for the scheduled internal Audits to check for compliance with cGMP, ISO requirements or other relevant requirements.
260	Semi-Finished Product	The definition semi-finished product stands for product that has not completed the full production steps, such as tablets waiting blistering, or filled vials waiting labeling.
261	Shelf Life	The Shelf Life, which is used to establish the Expiry Date of each batch is the timeframe at which a drug product is expected to stay within its predefined specification.
262	Shelf Life Specification	The predefined combination of physical, chemical, biological and microbiological test Requirements that a drug product must meet during its shelf life or a drug substance up to its retest.
263	Shipping	The term shipping is used in the GMP environment for the transport of any pharmaceutical product or ingredient in accordance with the GMP regulations.
264	Shipping Temperature	Product temperature value/ range set during the transport of finished product to ensure its integrity.
265	Side effect	Secondary and usually adverse effect, as from a drug or other treatment. For example, nausea is a side effect of some anticancer drugs.
266	Signature	Identification of person either printed (signed) or electronic.
267	Site	A site is called any facility where GMP operations for Drug Product or Drug substance, a testing, a research or distribution are conducted.
268	Site Master File	A site master file is the comprehensive documentation describing the facilities, utilities, computer systems, organizational structure and manufacturing processes at a site.
269	Site Validation Master Plan	The site validation master plan describes the assessment of the validation for the sites facilities, utilities, computer systems and manufacturing processes.
270	Solvent	Any liquid used as a vehicle for the preparation of solutions or suspensions in the synthesis of an API or intermediate.
271	Specifications	The term specification is used for the predefined written, chemical, physical, biological and environmental characteristics for testing a product or system. This includes but is not limited to starting materials, packaging materials, intermediate, bulk, drug substance or drug product.
272	Stability	The term stability is used for the ability of a drug product or drug substance to stay in there chemical, physical, microbiological and biopharmaceutical specified limits during its whole shelf life.
273	Stability Program	The stability program is a planned and documented program assessing the stability profile of materials and products to establish their retest periods or shelf life and storage directions.
274	Stability Testing	Stability testing is the testing used to provide evidence on how the Quality of an API or Drug Product varies with time under the influence of a variety of environmental factors such as temperature, humidity and light.
275	Standard Operating / Operation Procedure (SOP)	A SOP is an authorized and approved written procedure giving instructions to perform standard operations.
276	Starting Material	A material used in the synthesis of an API, which is incorporated as an element into the structure of an intermediate and/or of the API. Starting materials are normally commercially available and of defined chemical and physical properties and structure.
277	Statistical Control	Process for which the observed values are scattered about a mean value in such a way as to imply that the origin of the variations is entirely random with no assignable causes of variation and no runs or trends.
278	Statistical Process Control	Statistical Process Controls are statistically based techniques, e.g. for measuring and trending for the assessment and control including special cause variation in a system or process.
279	Status	The term status in the GMP environment is commonly used for an assessment of the condition of equipment, materials or processes.
280	Status Label	A status label is a designation, physically or electronically indicating the acceptability for use, further processing or distribution of any material, product, or equipment such as quarantined, approved, rejected, restricted use, etc.
281	Sterile Product	Products that have been processed to ensure that there is absence of living organisms.
282	Stock Recovery	The removal or correction of a product that has not been marketed or has not left the direct control of the site.
283	Storage Temperature	Product temperature value/ range set during the storage of finished product to ensure its integrity. Storage temperature may be different than shipping temperature.
284	Strength	The concentration of the drug substance ( for example, weight/weight, weight/volume, or unit dose/volume basis) and/or, The potency, that is, the therapeutic activity of the drug product as indicated by appropriate laboratory tests or by adequately developed and controlled   clinical data (expressed, for example, in terms of units by reference to a standard).
285	Subject Matter Expert (SME)	A company employee who has demonstrated competency and mastery in a particular process or function. These individuals are called upon to answer question or provide detailed explanation of processes pertinent to their area of expertise during an inspection.
286	Submission Document	One document, or several documents, comprising a submission to the FDA or other regulatory body.  A submission document may be a paper or an electronic (e.g., .pdf) document.
287	Submission Module	Where the Common Technical Document (CTD) format is used, a Submission Module is one section (generally consisting of multiple documents) of the submission.  The CTD is divided into five modules: ·         Module 1 – Administrative Information and Prescribing Information ·         Module 2 – Common Technical Document Summaries ·         Module 3 – Quality ·         Module 4 – Nonclinical Study Reports ·         Module 5 – Clinical Study Reports
288	Supplier Audit	A Supplier Audit is a formal quality review of a supplier of goods or services for a company.
289	System Qualification	System Qualification (SQ) consists of the IQ/OQ documentation pertaining to all equipment, instruments, materials and subsystems within a specific system or unit operation, generally identified by a single Piping & Instrument Flow Diagram (P&ID).
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290	Technical Agreement, Technical Quality Agreement, TQA	A technical agreement sometimes also called quality agreement or quality technical agreement is a contract agreement which states the manufacturing and quality control provisions as well as the GMP provisions required. The rules should be stated as part of this Agreement (e.g. immediate information about changes in production or manufacturing failures).
291	Technical committee	Committee involves the personals having the technical knowledge of subject of respective department to participate for the recommendation of CAPA or identification of impact of deviation or identification of control measures of the change control. The member in technical committee can vary from case to case as per the subject. Though, SME's for the relevant matter under discussion, HODs of respective department and QA personal is required.
292	Theoretical yield	The quantity that would be produced at any appropriate phase of manufacture, processing, or packing of a particular API or intermediate, based upon the quantity of components to be used, in the   absence of any loss or error in actual production.
293	Therapeutic category	Group of drugs intended to treat or cure a particular disease or related diseases. Several of these categories are antibiotics (drugs that prevent, inhibit or destroy microorganisms), cardiovascular (drugs that treat diseases of the heart and blood vessels), hypnotics (drugs that induce sleep), and nonsteroidal anti-inflammatory drugs or NSAIDs (drugs used to treat pain, fever and swelling).
294	Third Party Manufacturing	The term Third Party Manufacturing is used for outside contract manufacturers, testing laboratories or packagers.
295	Toxic Impurity	A toxic impurity is any impurity having significant undesirable biological activity.
296	Toxicology	Scientific discipline concerning the identification and effects of poisons and the treatment of poisoned individual.
297	Training On-the-job	The Training- On-the-job is the development of knowledge, skills and attitudes through training in the workplace. Training methods may include verbal instruction, physical demonstration, including group discussion, simulation, case studies and surveys.
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298	Unidentified Impurity	An unidentified impurity is defined as an Impurity that is identified solely by qualitative analytical properties, e.g. chromatographic retention time.
299	Unplanned Maintenance	Unplanned Maintenance is any maintenance, which must be conducted on short notice because of an occ0orence, also known as breakdown maintenance or repair.
300	User Requirement Specification (URS)	The user specifications are the specifications written down in a document describing in detail the requirements of the customer (user) with which the e.g. product, materials, process or computer system must confirm.
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301	Validation	The term validation is used to demonstrate with written evidence that the item under consideration, e.g. process does what it purports to do. Validation includes but is not limited to: equipment, computer systems, production processes, cleaning procedures, facilities, utilities as well as analytical methods.
302	Validation Master Plan	The Validation Master Plan is a summary plan which communicates management’s expectations and commitments to be followed for the sites validation program including the responsibilities and is therefore a key document at a site. It describes the program to be conducted to get the items in question in a validated manner. The plan lists all of the validation activities to be completed, as well as the schedule for their completion.
303	Validation or Qualification Plan	A validation or qualification plan is a written plan stating how the particular Validation/Qualification will be conducted. This includes but is not limited to the individual tests to execute and the key and critical operating variables, equipment, number of repetitions as well as the acceptance criteria.
304	Validation or Qualification Report	The Validation or Qualification Report concludes summaries and approves the relating result of the Qualification/Validation activities and data with respect to the protocol requirements and acceptance criteria.
305	Validation protocol	A written plan stating how validation will be conducted while identifying specific acceptance criteria. For example, the protocol for a typical manufacturing process identifies processing equipment, critical process parameters/operating ranges, product characteristics, sampling and test data to be collected, number of validation runs, and acceptable test results.
306	Verification	The term verification is broadly used in the GMP environment describe the act of reviewing, inspecting, testing, checking, auditing or otherwise establishing and documenting whether or not items, processes, services or documents conform to specified requirements.
307	Verified By	The person responsible for observing the actual procedure or witnessing performance of the task or performing an independent check to ensure the task was done correctly.
308	Viable Contamination	The term viable contamination is used when a product or a device is contaminated with any sort of living organisms.
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309	Warehouse	The warehouse for pharmaceutical products in a GMP environment is a registered facility of an authorized distributor operated in compliance to all applicable GMPs.
310	Warning Letter	Letter issued by the FDA to notify a facility that specific issues were not Satisfactorily addressed from a previous Form 483 or issues are significant enough to issue a more severe regulatory action.
311	Work or Inspection Instruction	Those documents used to convey, to the work place, the requirements of the purchaser and how the specified quality is to be achieved.
312	Working standard	An API, intermediate or other substance of established quality and purity, as shown by comparison to a primary reference standard, used as a reference for routine laboratory analysis.
313	World Health Organization (WHO)	A specialized agency of the United Nations that acts as a coordinating authority on international public health.
314	Worst Case	Worst case is term commonly used to describe set of conditions encompassing upper and lower processing limits and circumstances posing the greatest chance of process or product failure, compared with ideal conditions.