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Abstract

IN PROCESS QUALITY CONTROL: REVIEW

Manikanta Kumar Y.S.S.*, Deepthi R. and Srinivasa Rao Y.

Abstract

The drug development is a very tedious process which involves drug discovery, animal studies, laboratory testing, clinical studies and trails and regulatory registration. After approval of drug product several agencies like United States Food and Drug Administration (USFDA) require drug to be tested for its quality, purity, strength, identity and stability before it is released into the market for use. This testing is done to improve the effectiveness and safety of the drug. In this process Pharmaceutical Validation and Process control are the important aspects to encounter the problems of quality, safety and efficacy. Process control involves in inspection of raw materials, inprocess control and target for final products. These checks and tests are done before the manufacturing process is completed. Monitoring and if required adaptation of manufacturing process in order to meet the specifications are the functions of in-process quality control. This may also include control of environment and equipment. In-process materials should be tested for quality, purity, strength, identity and stability and should be approved or rejected by quality control unit at the time of production. The rejected in-process materials should be controlled, identified and stored under quarantine in order to prevent the use during manufacturing process.

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