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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
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