1. OBJECTIVE
To lay down a procedure on
responsibilities of Quality Assurance department.
2. SCOPE
This procedure applies to
define key responsibilities of Quality Assurance department personnel
3. RESPONSIBILITY
3.1. All QA
Personnel responsible to comply the procedure.
4. PROCEDURE
4.1. General
Responsibilities:
4.1.1. The
Quality Assurance department (QA) is responsible for the design, development,
qualification, implementation, evaluation, control, requalification, approval
and disposal of the complete manufacturing process at any stage(s)
of facility and equipment compliance, material compliance, process
compliance, personnel compliance and product compliance, with respect to market
and regulatory. The key functional areas are:
4.1.1.1. Organization
and Personnel
4.1.1.2. Building
and Facilities
4.1.1.3. Equipments
4.1.1.4. Control
of Components and Drug product containers and closures
4.1.1.5. Production
and Process control
4.1.1.6. Packaging
and Labelling Control.
4.1.1.7. Holding
and Distribution.
4.1.1.8. Laboratory
controls.
4.1.1.9. Records
and Reports.
4.1.1.10. Returned and
Salvaged drug products
4.1.2. QA
shall be responsible to formulate systems for the implementation of cGMP and to
ensure the preparation, approval and implementation of Standard Operating
Procedures, Standard Cleaning Procedures, Specifications, Standard Test
Procedures, Validation Protocols, Stability Protocols, Master Batch Production
Records, General Test Procedures etc.,
4.1.3. The
systems which shall be under the preview of QA are:
4.1.3.1. Document
Management System
4.1.3.2. Change
Control System
4.1.3.3. Deviation
Reporting and Failure Investigation
4.1.3.4. Qualification
/ Validation of facility, equipments and
Systems.
4.1.3.5. Vendor
Qualification
4.1.3.6. Batch
Release for market
4.1.3.7. Annual
Product Quality Review
4.1.3.8. Internal
Audit System
4.1.3.9. cGMP
Training & on Job Trainings
4.1.3.10. Product
Complaint and Recall Management System
4.2. Specific Key Responsibilities of QA:
.
4.2.1. QA
shall approve and verify implementation of defined systems, standards and
procedures. QA shall ensure approved procedures and specifications are in place
for reference.
4.2.2. QA
shall ensure document control, proper storage and retrieval of records and
destruction of obsolete documents.
4.2.3. QA
shall be responsible for evaluation and qualification of vendors of raw
material and packaging material.
4.2.4. QA
shall be responsible for sampling of in process materials; finished products
reserve samples and stability samples.
4.2.5. QA
shall be responsible to review and approve Validation Master Plan
and validation protocols, to review changes in product processes,
equipments, or any other changes as per Change Control Procedure SOP.
4.2.6. QA
shall be responsible for Line Clearance for Product change overs in process
quality control and Verification during dispensing of
materials.
4.2.7. QA
shall be responsible to release or reject the batch, after reviewing the Batch
Production Records to assure that the batch has been manufactured as per the
Master Batch Production Record and there are no deviations and if any, they are
recorded and authorized.
4.2.8. QA
department verify reconciliation of batch inputs, batch yields and finally
release the product for dispatch.
4.2.9. QA
shall be responsible for auditing methods, results, systems and processes and
for performing the trend analysis and preparation of annual review of drug
product quality.
4.2.10. QA shall
be responsible for self inspection and or quality audits which regularly
appraises the effectiveness and applicability of QA system.
4.2.11. QA shall
be responsible to release the finished products and to maintain the reserve
samples of finished product and batch production and control records.
4.2.12. QA shall
be responsible to investigate market complaints in co-ordination with concerned
department and to maintain market complaints investigation records.
4.2.13. QA shall
be responsible for issue, control, review and retrieval of worksheets, batch
production records, registers and files and ensure reconciliation.
4.2.14. QA shall
be responsible for disposition of Incidents/OOS and approval of deviations.
4.2.15. QA shall
be responsible for monitoring of stability studies.
4.2.16. QA shall
be responsible for annual product review and evaluate product and process
performance.
4.2.17. Head -
QA shall be responsible for initiating recall, monitoring quantity of recalled
material and final disposition.
4.2.18. QA shall
be responsible for handling of returned drug products for reasons other than
product recall.
4.2.19. Head -
QA shall be responsible for issuing the field alert for any situation leading
to a field alert.
4.2.20. QA shall
be responsible to ensure cGMP trainings and on the job trainings of all personnel.
4.2.21. QA shall
ensure compliance of national and International regulatory, cGMP / GLP
requirements; ensure implementation of amendments in specifications and
procedures as per current Pharmacopeial standards.
4.2.22. QA shall
ensure implementation of Pest and rodent controls, as per defined
schedules.
4.2.23. QA shall
be responsible for Environmental Qualification and Media fill assessment.
4.2.24. QA shall
be responsible for audit compliance.
5. ENVIRONMENT,
HEALTH AND SAFETY
Not Applicable
6. ABBREVATIONS
/ GLOSSARY
6.1. OOS :
Out of Specification.
6.2. GMP :
Good Manufacturing Practice.
6.3. GLP :
Good laboratory Practice
6.4. SOP : Standard
Operating Procedure.
6.5. QA : Quality
Assurance.
6.6. Ltd. : Limited.
6.7. e.g. : Example.
7. REFERENCES
Not Applicable
8. FLOWCHART
Not applicable
9. FORMATS
Not applicable
10. CHANGE
HISTORY
ConversionConversion EmoticonEmoticon