Journal article Open Access

IN-PROCESS QUALITY CONTROL: A SYSTEMATIC APPROACH TO CONTROL CRITICAL STEPS IN FINISHED PHARMACEUTICAL PRODUCTS

Varsha Kshirsagar

The main objective of pharmaceutical industry is to manufacture the quality products. Quality cannot be tested in the product it should be built- in by design and verified during the process with careful attention to the extent possible rather than depend alone on the end product testing. Many factors are responsible to give assurance of the quality of product. One of them is In-Process Quality Control Checks (IPQC). Critical points of all stages of the manufacturing process being checked by In-Process Quality Control according to standard operation procedures (SOPs). These applied SOPs vary from one finished dosage form to another. The acceptance criteria for the critical steps are also varying from product to product; it is close to the final release specification. The aim of In-Process Quality Control checks is to monitor and improve effectively the whole applied operations at the every stage of the finished pharmaceutical products. The In-Process Quality Control check ensures that the finished dosage form fulfills all quality requirements.

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