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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.

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Untitled Document