Technology Transfer :
Validation :
- Receipt of product design documents from Research Center.
- Distribution of documents received from Research Center (RC).
- Checking & approval of documents generated based on RC documents i.e. Batch Manufacturing Record.
- Scale-up and validation of product
Validation :
- Preparation of validation plans for facility / equipments / process including cleaning.
- Approval of protocols for validation of facility / equipment / product / process.
- Team member for execution of validation of facility / equipment / product / process.
- Controlled distribution and archiving of documents.
- Control of changes made by proper change control procedure.
- Approval of all documents
- cGMP training
- SOP compliance
- Audit of 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
- Feedback received from the compliance team
- Proposals for corrective & preventive actions
- Annual products review
- Trend Analysis of various quality parameters for products, environment & water.
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