Quality Control System

Quality Control department has experienced and qualified staff. The head of the quality control department has sufficient experience in Quality control functions, as applicable to pharmaceutical formulations.

Quality control personnel are responsible for sampling and analysis as per approved specifications. Release/ reject authority for all raw materials, packing material and finished product lies with the quality control only, but the final release authority for product lies with Quality Assurance.

The laboratory has designed and equipped with facility for chemical, instrumental, microbiological and stability testing. Microbiological area is provided with laminar air flow and other facilities to carry out microbiological testing and environmental monitoring.

Quality Control Activities
* Preparation and approval of detailed instructions for carrying out tests, based on the specifications laid down by Loan License parties and Pharmacopoeia. Instruction include test methods for raw materials, chemicals intermediates, in-process materials, packaging materials and finished goods. (Q.C)
* Sampling of Raw materials, Packaging materials in-process and Finished Products as per the sampling plan. (Q.C)
* Testing of Raw materials, packaging materials, in process and finished goods. (Q.C)
* Releasing / rejecting raw materials and packaging materials. (Q.C)
* Establishing and revising control procedures and specifications. (Q.C)
* Evaluating the stability of finished goods. (Q.C)
* Ensuring that Good Manufacturing Practices are adhered to during all manufacturing operations. (Q.A)
* Reviewing and approving batch manufacturing records prior to release. (Q.A)
* Releasing/Rejecting finished goods. (Q.A)
* Documentation, this include preparation of SOPs & maintenance of records. (Q.A)
* Investigation of market complaints, maintaining records and suggesting corrective actions. (Q.A)
* Conducting Internal GMP Audits. (Q.A)
* Examination of goods returned from the market and suggest redressing/Destruction of the same. (Q.A)
* Validation of process. (Q.A / Q.C / Prodn)

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