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 Overview of Compliance for Biopharmaceutical Process Validation

Approximate Time: 2 hours

Who Should Attend:

This course is designed to provide a quick overview of compliance considerations for validating a biopharmaceutical manufacturing process. Personnel in Development, Manufacturing, Validation, QA, and QC involved in process validation and process control should attend.   Course assumes the attendee has a basic understanding of the GMP regulations.  

Course Description: 

Firms manufacturing biotechnology-derived pharmaceuticals face special requirements in the validation of their processes and rigorous scrutiny from Regulatory Agencies that are well aware of the extent to which the process defines the product in this field.  This course reviews and interprets the specific regulatory requirements, provides examples of the required documentation, and discusses current industry trends and regulatory hot topics. 

A mindset is presented to include consideration for Process Validation in all aspects of manufacturing, including describing the Quality Assurance role, what must be accomplished as early as the process development lab bench, compliance considerations for raw materials, how process tolerances and uncertainties affect critical parameter ranges, assay issues, scale up issues, and considerations in technology transfer.

In addition to demonstrating that the process itself is under control, several key additional process characterization studies are required for biopharmaceuticals.  Requirements for these are discussed in detail, including genetic stability, DNA and host-cell protein removal, clearance of process additives, viral clearance/inactivation, process pool hold times, buffer hold times, chromatography cleaning, storage and reuse, and membrane cleaning and reuse. 

Course Topics include:

bulletIntroduction to Biotech Process Validation
bulletQA Role in Process Validation
bulletProcess Validation Documentation
bulletEvaluating Process Parameters
bulletProcess Validation Support Studies
bulletProcess Validation and Product Approval

NOTE:  This course is also available in an expanded 2 day version that covers many more details of the applicable regulations, as well as including many more examples and participant exercises to ensure the material has been assimilated.


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CBER on Process Validation

You need to remember one thing, I would say 'know thy process and thy product'  ... because if you understand the process and the product, you will make validation much, much easier. Your explanations when you are evaluating critical processes and operating parameters should clearly be supported by the data -- the selection of those, and for the validation part. And a clear emphasis on statistics is appropriate for the specific task (for example: determining what is the probability of detecting a virus in your systems; and also maintenance statistical process control to let you know when you are starting to err prior to it happening.)

Christopher Joneckis, FDA
FDA/PDA Joint Conference
September 2000

Copyright 2003 Compliance Net, Inc.

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