You know you need a validation master plan, but what should it include and what separates a strong validation master plan from an ineffective one?

Marie Thibault

We asked Ken Link, director of quality systems and compliance at NAMSA for his insights on the validation master plan in a short Q&A. Link will be leading a session on "Standardizing Your Validation Master Plan" on Tuesday, June 9 at the MD&M East Conference in New York City. 

MDDI: What are the key components of a Validation Master Plan (VMP)?

Ken Link: The key components to include in a Validation Master Plan (VMP) would be the Background (provides context to the validation effort), Process Flow Chart (show the interrelationships between all of the processes included in the scope of the VMP), and the Process Matrix (a key element that identifies each process, associated equipment, and all related validation protocols).

MDDI: Are there any areas or items that are often overlooked in an VMP?

Link: Often the Background section is either overlooked entirely or completed in a very superficial manner. This is a missed opportunity as this section can provide valuable history, context, and overview of the validation work covered in the VMP. Basically it can help tell the story behind the validation work.

MDDI: In the eyes of an FDA inspector, what is the most important thing to see in an VMP?

Link: Although a VMP is not actually a requirement in a regulation or standard, it is an expected document by external auditors and regulators, especially for large projects such as a facility move or new product development project. That said, one of the most important elements in a VMP is the process matrix listing all of the processes covered under the scope of the VMP including reference to specific IQ/OQ/PQ protocols.

MDDI: What special considerations, if any, should companies with multiple product categories (devices, pharma, diagnostics) keep in mind when creating a VMP?

Link: If using a VMP to cover all the validation activities at a given facility, the plan can be broken out into sections covering each one of the different product categories. However, another common approach is to use a different VMP for each product family/category. Regardless of the way the plan is structured, if pharma products are involved then there are specific guidance documents regarding process validation that need to be taken into account when developing and executing the VMP.

What are the repercussions of having a weak VMP?

Link: If a VMP is unclear, inaccurate, or not well organized, then it is possible that certain required elements of the validation effort could be inadequately executed or missed altogether resulting in potential compliance issues and/or processes that do not perform as intended.

Marie Thibault is the associate editor at MD+DI. Reach her at [email protected] and on Twitter @medtechmarie. 

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