Quality Control

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  1. To approve or reject all components, drug product containers, closures, in process materials, Packaging materials, labeling and drug products.
  2.  Review production records to assure that no errors have occurred, or if errors have occurred,  that they have been fully investigated.
  3. Provide adequate facilities for required testing.
  4. Approving or rejecting all procedures or specifications impacting on identity, strength, quality & purity of the drug product.
  5. Validation of test methods.
  6. Maintaining records.
  7. Evaluate, maintain & store reference standard for substances.
  8. Monitor stability of products.
  9. Participate in complaint investigation.
  10. Participate in environmental monitoring

Semi-finished and finished products are released for packing and for sale or distribution by Quality Assurance department after ascertaining process control clearance. Quality Assurance draws samples of each product and each batch at appropriate interval during entire batch production as per the sampling program. Complete analysis is done as per the releasing specifications by Quality Control. Results are recorded in test protocols and reports.

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