This article explains what a master validation plan is, when is it appropriate to have a master validation plan, and when you need one.
Master Validation Plan
In the United States, there are two applicable regulations for medical device manufacturing process validation: 1) 21 CFR 820.75, and 2) ISO 13485, Clause 7.5.2. Neither the QSR regulation nor the ISO 13485, include any mention of a master validation plan. There is a requirement for product realization planning, and a master validation plan could be an essential part of that planning. However, master validation plans are not mentioned anywhere.
MDD – Master Validation Plan?
For companies that manufacture CE Marked products, the term validation appears in the MDD (93/42/EEC as modified by 2007/47/EC) a total of two times. Only one of those references is specific to process validation, but there is no mention of a master validation plan. The single mention of validation appears in Annex VII, and the reference is specific to the requirement for including a copy of the sterilization validation report in a technical product file.
CMDR – Master Validation Plan?
For companies that hold one or more Canadian Medical Device Licenses, “validation” appears in the Canadian Medical Devices Regulations (CMDR) a total of eight times (four times as part of the French translation). The first four references are part of the definition of validation, where the CMDR is referring to design validation. The remaining four references specifically mention the requirement for the inclusion of process validation and software validation in a medical device license application for Class IV devices. None of those references say of a master validation plan.
Not only is there no mention of a requirement for master validation plans in any of the medical device regulations, but there is also no mention of installation qualification (IQ), operational qualification (OQ), or performance qualification (PQ). The only mention of validation protocol or report appears in 21 CFR 820.70 as it refers to using validation protocols for validation of software controlling automated equipment.
21 CFR 210 or 21 CFR 211 requirements?
The requirements for medical devices historically are derived from pharmaceutical regulations–which included the requirement for process validation. However, neither 21 CFR 210 nor 21 CFR 211 mention master validation plans (need to verify). They also don’t mention IQ/OQ/PQ requirements.
Where did the idea for Master Validation Plans Come From?
GHTF/SG3/N99-10:2004 is the guidance document that was created by the Global Harmonization Task Force’s Study Group 3 for guidance on process validation. The guidance even includes templates for a master validation plan, IQ, OQ, and PQ. The guidance indicates that the purpose of a master validation plan is to plan validation and revalidation activities. There are other planning documents that could be used instead. For example, design plans include process validation as part of the design transfer activities when a new product is being developed. Quality plans are used for facility expansions and construction of new facilities. Some companies even include validation and revalidation plans in their process validation procedure and/or sterilization validation procedure.
For companies that have equipment that requires validation, I like to use an equipment register that identifies calibration, preventive maintenance, validation, and revalidation requirements as part of the equipment register. This allows me to use one single document to manage all the planning of calibration, preventive maintenance, and validation. If there are no validation requirements, then the appropriate column of the equipment register will indicate “n/a.”
What is a Master Validation Plan?
A master validation plan (MVP) is simply a plan for your equipment and process validation activities. All the equipment, processes, and software requiring validation should be included in the MVP. The plan should reference the applicable protocol and report for each item in the plan. If there are revalidation requirements, the plan should indicate when the last validation was performed and what the frequency of revalidation should be. Ideally, similar equipment will use the same validation protocols that are controlled documents and pre-approved. Over time the number of reports referenced will increase, but the plan should only reference the most recent approved protocol(s).
Some companies include the rationale or triggers for revalidation in the plan–just as you would for a record retention table. However, other companies will include this detail in the validation protocol and/or in the process validation procedure. The rationale for revalidation only needs to be in one of three places, and duplication of the information just encourages errors and audit non-conformities.
Procedures & Templates
We also have a process validation procedure.