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Clarifying the Difference in Equipment Qualification and Process Validation

June 10th, 2014 by

Process ValidationHow do you know your life sciences firm is maintaining compliance? While FDA audits and warning letters are obvious indicators, GMP guidelines give you a number of less-stressful ways to determine how well your equipment and processes are performing their tasks and whether they’ll continue to do so consistently.

Although equipment qualification and process validation seem to overlap in some areas, they’re two distinct practices, and your quality management system must attend to each in its own right.

Validation versus Qualification

In order to assure that a specific GxP-regulated endeavor will be successful, you have to assess all equipment used to complete the task. When evaluating the capability of a specific facility, system or piece of machinery to perform in accordance with defined acceptance standards, we use the term qualification.

Of course, it’s also important to compile verifiable evidence that the processes you rely on are going to create compliant output. When referring to the act of documenting such demonstrative information, the term validation is used.

Do Validation and Qualification Overlap?

In practice, validation and qualification are closely related. If you’ve qualified a specific piece of equipment yet fail to validate the operating procedures you’ll employ with it, your job is incomplete. If you want to validate a large-scale manufacturing procedure, you’ll also have to ensure that the relevant facilities, HVAC support systems, vendors and analysts have all been qualified.

This seems straightforward, but validation procedures can be complex. Firms that seek to validate cloud services, for example, may have to qualify numerous hardware components, server facilities and software packages along the way. While such tasks present potentially monumental workloads with systems whose components are already in place, life sciences firms may be able to lighten their burdens by working with consultants during the planning stages in order to implement more manageable quality systems.

Making Sense of Equipment Qualification and Process Validation

Many firms maintain some form of validation master plan (VMP) in order to make the overall process easier. These documents delineate different processes that need to be validated, and they also describe the specific steps involved in qualifying their components. Furthermore, the VMP is used to inform the necessary employees of the company as to when the next validation / qualification is to take place. Thus this document plays an essential part in the compliance strategy of any firm.

Validation master plans aren’t explicitly mandated by the FDA. Nonetheless, such agencies often request copies as supplements to medical device premarket applications or as part of compliance audits. A well-defined validation scheme that clearly indicates the reasons behind your quality control methodologies is essential to proving that your organization is responsible enough to bring a product to market.

Strategies to Maintain Compliance

With or without a master plan, your equipment qualification and process validation strategies are going to be scrutinized by regulators. Adopting a structured approach towards mastering these vital fields will make it easier to maintain compliance. It can also improve the way you manage your business.

By qualifying your IT infrastructures, manufacturing equipment and facilities, you ensure that your output will be consistent enough to meet stringent regulatory demands. By validating your processes, you’ll make it easier to implement a cost-effective compliance strategy.

Equipment qualification and process validation may be simplified when you work with consultants who have experience building comprehensive quality systems using integrated technologies and industry-vetted techniques. GxP-CC maintains a capable staff with almost three decades of real-world experience creating viable compliance implementations. Discover how GxP-CC can improve your compliance efforts by contacting them today.

 

About this author:

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For over 15 years Mr. Francum has worked in regulated environments directing and orchestrating the various components involved in assuring compliance of the most stringent regulatory requirements. He is an internationally recognized expert and has extensive experience in over 25 countries including, but not limited to, the regions of North America, Latin America, Europe and the Middle East.

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