PROCESS VALIDATION IN PHARMACEUTICAL INDUSTRY; AN OVERVIEW
Quality cannot be adequately assured by in-process and finished inspections and testing but it should be built in to the manufacturing process. These processes should be controlled in order that the finished product meets all quality specifications Validation is one of the important steps in achieving and maintaining the quality of the final product. If each step of production process is validated we can assure that the final product is of the best quality. Validation of the individual steps of the processes is called the process validation. Different dosage forms have different validation protocols. Quality is always an imperative prerequisite when we consider any product. Therefore, drugs must be manufactured to the highest quality levels. Process Validation is one of the important steps in achieving and maintaining the quality of final product. It gives a higher degree of assurance.KEY WORDS: Process validation, CGMP, GMP, Validaton protocol , SOP
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