Production & Packaging

Handling Produced Goods

The batches when ready for packing, are segregated and stored in quarantine with proper identification labels. The Quality Control Department, samples and analyst every batch of products, at the bulk and final stage. On the clearance from the Quality Control Department, the batch is released for further processing and packing. Reference samples are collected and maintained by Quality Control Department. After packing of the batch is completed, the same is transferred to BSR and kept segregated with identification tag, to indicate its status of "Under Test".

The Quality Control Department, then carries out necessary testing of samples of finished products. In-process records are evaluated and Batch Manufacturing Records are audited, then only Quality Control Department releases the batch for distribution. Records of the same are maintained by the Quality Control Department. A detailed procedure is mentioned in the 'Methodology' file maintained by the Quality Control Department.

 

Handling Rejected Materials & Products

All raw materials and packing materials are sampled and analyzed by the Quality Control Department. In case the sample fails to comply with the laid down specifications, 'Rejected' label is affixed to the concerned lot of the Raw materials. The Stores Department initiates further action on the material as per the laid down procedures.
 
In case of raw materials, the rejected lot is returned to the vendor, and all printed packing materials are destroyed at the premises as per the laid down procedures.

Process Validation Policy

Prospective process validation are done by R&D during development stage. Concurrent validations are done by R & D and production department during transfer of technology. Retrospective validations are done by Production and Quality Control Department.
 
Certain key processes and equipments like Sterile area filling machine after change over from corticosteroid to non-corticosteroid products etc. are validated routinely and the records are maintained by Quality Control Department.
 
Few processes are validated by Quality Control Officer in co-ordination with the Production officer and records are maintained thereof. These validated processes are re-validated routinely.

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