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Monday, January 30, 2017

Life cycle Approach to Process Validation” -Current Regulatory perspective & It’s Benefits

“Life cycle Approach to Process Validation” Part-1.





















“Quality has to be built-in into the process and cannot be relied on the testing of final product”

Definition of Process validation:

“The collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product.”


Process Validation (PV)” concept in pharmaceutical industry was first proposed by USFDA officials, namely, Ted Byers and Bud Loftus in mid-1970, who believed that, introduction of PV will help to improve the quality of pharmaceutical products. Though, initial proposal was in direct response to several problems in the sterility of large volume parenteral market and first validation activities were focused on the processes involved in manufacturing these products, which subsequently expanded to associated processes including environmental control, media fill, equipment  sanitization, purified water production, process equipment’s software, methods and processes etc.

First USFDA draft guidance document on “PV” came into existence in 1987. The objective of the guidance was to bring awareness among the pharmaceutical sphere in describing the agency’s thinking so as to produce safe and consistent quality of medicines to patients. As the new concepts of “Quality by Design/(QbD) ” emerge with the inception of ICH guidelines namely, Q8, Q9, Q10 & Q11 , which led to introduction of enhanced approach of validation as “Life Cycle Approach to Process Validation” explicitly outlined in the PV guideline released by USFDA in January 2011.

PROCESS VALIDATION – LIFE CYCLE APPROACH:

4 STAGE PROCESS:

The current life cycle approach to “Process Validation” divulges that PV is a journey and not a one-off event of just completing the 3 PV runs. All phases in the life of a product from the initial development through marketing until the product’s discontinuation are called life cycle approach to PV.
Enhanced PV model is a science and risk based approach aligning with the principles of “Quality by Design” articulated in ICH guidelines Q8, Q9, Q10 & Q11. A lifecycle approach is applied linking product and process development, validation of the commercial manufacturing process, and management of the process within the change management system to make sure maintenance of the process in a state of control during routine commercial production” is defined below:

Stage-1: Process Design: The commercial manufacturing process is defined during this stage based on knowledge gained through development and scale-up activities.

Stage-2: Process Performance Qualification (PPQ): The process design is evaluated to determine if the process is capable of reproducing commercial manufacturing.

Stage-3: Continued/Ongoing Process Verification PV/OPV): 
Ongoing assurance gained during routine production that the process remains in a state of control.

Stage-4: Change Management and Re-validation: 

Ongoing assessment of the process as part of change management system to ensure the re validation and maintain continuum validated state of control.


Author: Sanjeev Kumar Singh

Deputy General Manager - Corporate QualityAssurance at Mylan Laboratories Limited





Keywords: Process validations, Quality by Design, performance qualification, change management.





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