INDUSTRIAL PROCESS VALIDATION OF SOLID DOSAGE FORMS: A REVIEW

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. Here this article concentrates on the process validation of solid dosage forms, protocol preparation and regulatory basis for process validation with special emphasis on tablets in industry. It gives in detail the validation of each step of the manufacturing process through dry granulation.