Dear Paul, I'm a QA manager in a pharmaceutical company. We need to create a Validation Master Plan, can you offer some guidance from your experience in the field? Thanks in advance!/M
HI M, Thanks for contacting me! First, it's important to remember: A Validation Master Plan is not technically a regulatory requirement in the US. The actual regulatory requirement is that you have a clearly defined and documented validation program. However, a VMP is a regulatory requirement in Europe so I defer to my colleague Piritta Maunu here...
In my experience, you are subject to receiving a note of deficiency if you don't have a Validation Master Plan in place. Even if you have documents that are equivalent to a Validation Master Plan, it's preferred to have them in a master plan. EU GMP Vol. 4 Annex 15 says: “The key elements of a validation programme should be clearly defined and documented in a validation master plan (VMP) or equivalent documents.”
Thanks Pirre! Anyhow, a Validation Master Plan even in the US is an extremely good idea because it helps give sense and organization to your validation efforts, and an understanding of how it supports the goals of your facility. And, it makes auditors happy because they are used to seeing validation plans. My recommendation, for a starting point, is to do a web search on "validation project plan" and "validation master plan". You'd be surprised what kind of free materials and advice are out there. A search turns up these gems: Validation Master Plan from the Institute of Validation Technology (Note: The IVT is a great US organization and a good source for document templates) Pharmaceutical Master Validation Plan – by Syed Imtiaz Haider (Slideshare) So, there is guidance available! As for my own experience, please forgive me for recycling some advice, but a while back we created a Validation Master Plan checklist, so here it is again: So, there is guidance available! As for my own experience, please forgive me for recycling some advice, but a while back we created a Validation Master Plan checklist, so here it is again: I always worked under a Validation Master Plan. And while it's standard in the field, the Code of Federal Regulations will not yield a single mention of a "Validation Master Plan." However, the VMP is mentioned in many peripheral documents (see the links below). More importantly, if you scan Warning Letters and Notice of Observations (483s) you will see in the deviations Validation Master Plan. Obviously, if you are being inspected, you can expect to be asked for your VMP.
Essentially a VMP must outline the processes and equipment that require validation, and the job roles responsible for validating. A regulatory inspector wants to see a summary of the validation practices, listed by priority. Another source for information on this is The Pharmaceutical Inspection Co-operation Scheme has published a document called: "Recommendations on the Validation Master Plan, Installation, and Operational Qualification, Non-Sterile Process Validation/Cleaning Validation." This document, in combination with the PIC/s's "Good Practices for Computerised Systems in Regulated 'GxP' Environments" briefly outlines a Validation Master plan like so:
Here are other important documents on validation – worth reviewing before beginning your VMP:
ICH Quality Guidelines (QbD: ICH Q8, Q9, and Q10)
There's a lot of reading to do!
Paul Daniel is the Senior Regulatory Compliance Expert at Vaisala. He has worked in the GMP-regulated industries for over 20 years helping manufacturers apply good manufacturing practices in a wide range of qualification projects. His specialties include mapping, monitoring, and computerized systems.
At Vaisala, Paul oversees and guides the validation program for the Vaisala viewLinc environmental monitoring system. He serves as a customer advocate to ensure the viewLinc environmental monitoring system matches the demanding requirements of life science and regulated applications.
Paul also shares his GMP experience through regular blog contributions, webinars, and seminars around the world. Paul’s expertise in the demanding GxP world is applicable to any industry where measurement is critical to product quality. Paul is a graduate of University of California, Berkeley, with a bachelor's degree in biology.
Piritta Maunu has 15 years of experience in biotechnology, having worked in several quality management positions. Maunu holds a degree of M.Sc. (Cell Biology) and is certified to teach with a specialty in General Biology, both degrees from the University of Jyväskylä, Finland. In her role at Vaisala, she supports the sales department, assists the quality department with audits, creates educational content for life science customers, and provides application support to R&D teams creating solutions for monitoring critical environments.
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