Quality Assurance
Rhombus Pharma Pvt. Ltd. quality policy is mandated and supported by the Executive Management and coordinated by an independent Quality Assurance (QA) Department.
Highlights:
- Pharmaceutical plant with ISO 9001, revised Ch.M.& WHO-GMP certification.
- Quality Assurance is independence of Manufacturing.
- In-Process quality is checked during manufacturing.Validation of facilities, equipment’s, process, products & cleaning as per Master Plan.
- Complaint Handling.
- Storage of quality record and control samples.
- Stability Studies.
Quality Assurance Department handles the following activities:
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.
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: 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.
