PROCESS VALIDATION OF SOLID ORAL DOSAGE FORM AND PROCESS VALIDATION GUIDANCE FOR INDUSTRY

Validation is one of the important steps in achieving and maintaining the quality of the final product. Validation of the individual steps of the processes is called the process validation. Process validation's main objective continues to be the generation of a process which yields a product which meets pre-determined quality criteria. It is an important component in the design, prototyping and manufacturing process and one, if done correctly, that can save a considerable amount of time, money and resources. End-product testing by itself does not guarantee the quality of the product. Therefore Quality assurance techniques must be used to build the quality into the product at every step and not just tested for at the end. Process Validation performs this task to build the quality into the product at every step. FDA has released various guidelines for process validation. This guidance incorporates principles and approaches that all manufacturers can use to validate manufacturing processes. FDA considers appropriate elements of process validation for the manufacture of human and animal drugs and biological products, including active pharmaceutical ingredients