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Validation as applied for Pharmaceutical Processes

Abdrhman Mahmoud Gamil


As a part of cGMP validation is the quality assurance tool through which the drug process design assures that the process can withstand the variations during the process. Using the worst-case conditions, the critical process steps could be evaluated in the light of critical acceptance criteria. It starts with the qualification of the facility, utilities and equipment regarding the design, installation, operation and performance. Stages of PV involve the process design, process qualification, and continuous process verification. Validation may be prospective, concurrent or retrospective. Process control guidance and revalidation assures that the quality was built into the product. There should be a validation master plan; all activities are documented including protocols, reports and other supportive documents and team. For product development; traditional, continuous process verification, hybrid and design space techniques should be carried out. Cleaning validation for equipment and facility should be done on specific limits as traces of contamination may be drastic. The analytical methods if not validated will provide false results with it's consequences. Every step in the tablet manufacturing for example should be validated otherwise a deactivate procedure will have an extended impacts. Validation of sterile product manufacturing is absolutely vital. Terminal sterilization requires studies for heat distribution, penetration and biological elements used. Sterile filtration requires qualification of the facility, utilities and equipment. Invalidated sterile product manufacturing process may be life threating and risky. The end user, the regulatory bodies and the manufacturers are all wining the benefits of validation which should be the heart of the quality management systems.

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