Fitwel's quality policy is mandated and supported by the Executive Management and coordinated by an independent Corporate Quality Assurance (CQA) Department.
- Quality Assurance is independence of Manufacturing.
- In-Process quality is checked during manufacturing.
- Validation of facilities, equipments, process, products & cleaning as per Master Plan.
- Complaint Handling.
- Storage of quality record and control samples.
- Stability Studies.
- Registration Documents (DMF)
Quality Assurance Departmenthandles the following activities :
Technology Transfer :
- Receipt of product design documents from Fitwel Research Centre (FRC).
- Distribution of documents received from FRC.
- Checking & approval of documents generated based on FRC documents i.e. Batch Manufacturing Record.
- Scale-up and validation of product
- 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.
Documentation Control :
- Controlled distribution and archiving of documents.
- Control of changes made by proper change control procedure.
- Approval of all documents
Assuring Quality of Products:
- 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
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.