Validation Master Plan - Reading and Guidelines
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.”
Back to Paul...
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:
- A list of all validation activities: prospective, concurrent, and retrospective
- A list or copies of any parallel Validation Plans
- References to existing documents such as Policy Documents, SOP's and Validation Protocols/Reports
- A list of facility management who have agreed upon the master plan
- A statement of the firm's validation policy
- General description of the scope of the operations of the firm which describes the facilities, processes, and products
- The time and location of validation activities (ideally prioritized)
- A list of personnel responsible for the VMP, SOPs and protocols
- A list relevant validation reports and documents
- A list of personnel (roles) who provide approval
- Description of any tracking systems used for reference and review
- Validation training program plans - either the plans as appendices or references to the plans as separate documents
Here are other important documents on validation – worth reviewing before beginning your VMP:
ICH Quality Guidelines (QbD: ICH Q8, Q9, and Q10)
- FDA Guidance; Process Validation: General Principles and Practices (2011 Jan, Revision I)
- EMA Draft Guideline on Process Validation (March 29, 2012)
- Public Consultation on the revision to Annex 15 to the EU Guide to Qualification and Validation
There's a lot of reading to do!