Manufacturing
Quality Control
Quality Control for API / PM, Finished Products & In-Process Control is as follows:
We have a modern and well-equipped Quality Control (QC) laboratory, which ensures that our products are pure, safe, effective and are released only after thorough analysis as per stringent specifications, methods and procedures developed according to international guidelines. Our QC department has all necessary instruments for analysis of API, finished products, packaging and related materials used.
The QC department performs following activities:
- RM/PM analysis (Flowchart)
- Finished Products analysis (Flowchart)
- In-process Checks (Flowchart)
- Stability Studies
The QC activities are managed through four sections:
- Instrumental Analysis and Finished Products
- Wet Analysis Laboratory
- Microbiological Testing Laboratory
- Packaging Material -Testing Laboratory
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 Sch.M & WHO-GMP certification.
- 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.
Quality Assurance Department handles the following activities:
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.
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.
