The Enterey Blog

3 Simple Steps for Successful Process Validation Gap Analysis

Posted by Tita Tavares on Wed, Mar 30, 2011 @ 11:43 AM


FDA: NEW Guidance for Industry
Process Validation: General Principles and Practices

FDA issued its final guidance on Process Validation (Revision 1) on January 24, 2011. This guidance replaces the 1993 guidance.


This guidance reflects FDA’s current thinking on the topic and outlines the general principles and approaches that FDA considers appropriate for process validation for the manufacture of human and animal drug and biological products, including finished products, APIs, and combination products, and collectively referred to as drugs or products in the guidance.


This guidance aligns process validation activities with the product lifecycle concept and with existing FDA guidance, including FDA / ICH guidances for industry Q8 (R2) Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System. Although this guidance does not repeat the concepts and principles explained in these guidances, FDA encourages the use of these development concepts, QRM, and QS at all stages of the product and manufacturing process lifecycle.


FDA has the authority and responsibility to inspect and evaluate process validation performed by manufacturers. Process validation for drugs is a legally enforceable requirement under section 501(a)(2)(B) of the Act (21 U.S.C. 351(a)(2)(B). CGMP regulations for validating pharmaceutical manufacturing can be found in 21 CFR Parts 210 and 211.


Although FDA guidance documents are recommendations, pharmaceutical manufacturers are already assessing the scope of the new guidance and performing a gap analysis to initiate corrective action and remediate the gaps in their current standard operating procedures to enhance and align their process validation activities with FDA recommendations.


Successful Process Validation in 3 Steps

Step 1: read the FDA guidance for industry documents.

Step 2: complete a gap assessment.

Step 3: determine an action plan via CAPA to correct the gaps and maintain the changes to your
process validation activities and Quality System.

Published by: Jim Anthony, Enterey | Director 

Follow these steps and you’re on your way!
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Up next: Highlights in the new guidance document.

Tags: Corrective Action, FDA New Guidance for Industry, Process Validation, ICH Q8, ICH Q9, ICH Q10, Gap Analysis, Quality Risk Management, Pharmacautical Quality System, Steps to Successful Process Validation, CAPA