- Process control
- Implementation of Quality systems
- Directive and controlling of cGMP operations.
- Control of material specifications
- The monitoring and control of the manufacturing environment.
- Personnel Health and Hygiene
- Qualification and Validation activities
- Training
- Internal inspection, Investigation, and taking of samples
- Evaluation and approval of all validation protocols.
- Specifying sampling procedures.
- Evaluation and approval of all final SOPs.
- Review and approval of all Batch Production Records prior to release of finished goods
- Audit and approval of vendors
- Evaluation and analysis of market complaints and batch recalls.
- Routine finished product stability.
- Validation Master Plan is maintained
- In Process Quality Assurance
- External audit and compliance of the findings
- Review of Results for Adequacy of Quality System
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