PROCESS VALIDATION FOR SELECTED SOLID DOSAGE FORM AS PER FDA GUIDELINES

Rajender Singh*

An ultimate goal for science and technology should be the betterment of humanity and the welfare of human beings. In view of pharmaceutical industry, process validation is very important to deliver quality product for human beings. As per US Food and Drug Administration (FDA) guideline “Process Validation: General Principles and Practices” Process validation involves the collection and evaluation of data from the process design stage throughout commercial production that establishes scientific evidence that a process is capable of consistently delivering a quality drug substance. The purpose of this work is to present an introduction and general overview on process validation of pharmaceutical manufacturing process (CPP-Critical process parameters) with special reference to the requirements stipulated by the US Food and Drug Administration (FDA) of selected solid dosage form (Paracetamol).