Qualification/Validation Pitfalls: Why Is It So Hard? By Frank Caldwell and Gary Ruthrauff, R. Donnelly & Associates
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After more than 30 years of qualifying and validating equipment, processes, and facilities, it would seem unlikely that pharmaceutical companies do not have a well honed viable and value added system to run qualifications. The reality is that many firms still struggle with aspects of the qualification process and view it as "a necessary valueless evil." Opportunities to train personnel, reduce or eliminate costly down times and assure compliance to company goals are lost when the qualification process is not set-up or executed properly.
In this article, we are garnering our experiences, both good and bad, and allowing the reader to determine if they can use the good and weed-out the bad in their own situation. We have seen many well run and value added qualifications in our 30 years but have also seen just as many that have failed their intended purpose and forever gave the word "qualification" a poor name.
The majority of the time there are three items that enter into the decisions which lead to the loss of value:
- Expectations
- Time allotment
- Planning
Frank Caldwell
Senior Validation Consultant, R. Donnelly and Associates, Inc.
Frank is an experienced validation and operations professional in the pharmaceutical and biotech industries. He has been employed for 40 years in the industry with several firms and has provided skills for initiating, writing and implementing training, validations, project management, manufacturing procedures and regulatory compliance. Formally educated in Biology/Chemistry and business administration at Cleveland State University and Cuyahoga Community College he has also attended numerous courses, workshops and seminars in management, training and pharmaceutical industry to stay current with the latest developments.
Gary Ruthrauff
Senior Validation Associate, R. Donnelly and Associates, Inc.
Gary is an experienced Quality Assurance and manufacturing professional with over 30 years of pharmaceutical experience in small volume parenterals and ophthalmic/otic products. He has extensive knowledge in equipment, systems and process validation, client and regulatory audits and pharmaceutical manufacturing. Formal education is in Biology/Chemistry at Millikin University and has recently attended ISPE and validation courses and workshops.
•White Paper: Qualification/Validation Pitfalls: Why Is It So Hard?