Validation management, the glue that makes everyone understand the higher purpose

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When I first started working with validation, in my mind, it was simply about writing documents to keep the regulatory bodies satisfied so they continue to allow production. As long as the documentation is in place, the work is done. The mindset did not inspire me, nor did it bring out my passion. Back then, validation was simply “work”.

With several years as a validation engineer under my belt and have had the honor of working with truly inspiring and passionate people in the field, I now understand that validation is much more than simply “work”.

Validation is about gathering everyone together, to determine the best plan and solution for the end result. The requirements from the regulatory authorities can be frustrating and seem irrelevant, but they have a purpose: To ensure that all produced medicine have the consistent and intended effect and that the right processes and routines are in place to guarantee that.

For example, a User Requirement Specification (URS) is the base of any validation and the foundation of any project. It details the finished product or equipment’s function or capability. It is often the validation engineer’s responsibility to write the URS that reflects the needs of the business and the requirements of the regulatory authorities. By understanding the requirements, I can communicate and explain to other disciplines the purpose of the requirements and the way to reach an optimal solution. I assist with the design with engineering, inspect installations with maintenance, investigate disinfectants for the cleaning personnel and set up validation batches with planning. Everyone plays a part in validation and the validation engineer is simply the glue. Everyone has a purpose and a role in improving health and life for the user of the product, and my role is to make sure everyone understands that.

Knowledge matters

To fulfill my duty as a validation engineer, knowledge matters. From understanding how to interpret the EU Commission’s annexes to how to implement quality control systems in production lines. Knowledge is not only about the outlined texts in a regulatory document but also understanding about how my work will impact the user. There should never be an exclusivity to knowledge. Though we may be of different organizations, companies, or constellations, we all work for a common goal.

Knowledge-sharing increases the client value

It was with this belief I and my close colleagues started the “Validation Management Initiative”, to share knowledge and foster collaboration. Consultants with validation responsibility all have different experiences. Some have worked with large-scale production lines, unique in the world. Others with auxiliary equipment, designed to serve an oft-forgotten but just as a critical part of the process. A subject one consultant might have just stepped into, another has worked with for years. By arranging and participating in digital workshops and presentations, we share information freely within Knightec. An extra effect is that it brings colleagues closer together so that there is always somebody to turn to when the need arises.

For example, a new draft of the Eudralex Annex 1(*) was published this year, detailing new qualification routines for clean rooms and relevant media systems. With an experienced consultant sharing his/her knowledge via a digital platform, Knightec consultants across Sweden are better equipped to handle the oncoming challenges our clients will experience. Combining the stronger knowledge base with the consultants’ ability to perform, time and cost is reduced as well as the feeling of frustration that can hamper progress.

We want the clients to know that they are not limited to the expertise and experience of the individual consultant alone, but also the accumulated knowledge of Knightec. And we want the assigned consultant to feel that they are not alone, that they have the backing of colleagues who have overcome the same challenges. We do this together.

Validation is more than just “work”

Documents are tangible evidence of quality assurance, but what truly matters is the value added to the product, the process and ultimately, the user. With validation, I can make a difference to my clients, to my colleagues and to the users affected by my work. Which is why I see validation as more than just “work”.

Author

Hung Nguyen works as a senior consultant within validation and has many years of experience of validation and qualification in the Pharmaceutical Industry. Hung is a member of the Validation Management Initiative, working to deepen Knightec’s competence within Validation Management.

References
(*)European Commission. (2020). Second targeted stakeholders’ consultation on the revision of Annex 1, on manufacturing of sterile medicinal products, of Eudralex volume 4. Available at: https://ec.europa.eu/health/medicinal_products/consultations/2020_sterile_medicinal_products_en (Accessed: 2020-09-25).

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