Quality Assurance
Our Quality Assurance (QA) team is responsible for the overall control of the documentation system, all activities relating to compliance with this procedure and all cGMP requirements.
Documentation Control
- Controlled distribution and archiving of documents
- Control of changes made by the proper change control procedure
- Approval of all documents
Quality Improvement Plans
- Feedback received from the compliance team
- Proposals for corrective & preventive actions
- Annual products review
- Trend Analysis of various quality parameters for products, environment & water
Validation
- Preparation of validation plans for facility / equipment / process including cleaning
- Approval of protocols for validation of facility / equipment / product / process
- Team member for execution of validation of facility / equipment / product / process
Assuring Quality of Products
- cGMP training
- SOP compliance
- Audit of the facility for compliance
- Line clearance
- In-process counter checks
- Critical sampling
- Record verification
- Release of batch for marketing
- Investigation of market complaints
- Stability of products