Validation master plan

[evan_kim90]

Hi,

During the last audit, the auditor mentioned the necessity of a Validation Master Plan (VMP). Currently, we maintain an Excel file that records all working processes and indicates whether each process requires validation or not.

Is this Excel file sufficient to present to the auditor, or should we have a formal Validation Master Plan Standard Operating Procedure (SOP)?

If we do require an SOP, could you please share a template?

Thank you in advance for your assistance.

Best regards,

 

[shimonv]

A master validation plan is formal record, so a live excel file will not do.
I don't think you need an SOP for master validation plan; you can merge the instructions with design control SOP or V&V SOP, if you have.
The master validation plan should include the list of V&V tests with description and references.

Shimon

 

[Tidge]

Years ago, but not long after "design controls" were required, I was at a company that had implemented a rather simple Master Validation Plan that was more-or-less "OK"... it was pretty much a commitment that all test methods and production processes would be assessed if they required validation, and if not... why not (allowing for outputs to be 100% verified). We (effectively) kept an excel list referencing all the documents generated to support the plan. There was slightly more to the MVP... for example, required periodic assessments of validated process, some magic words about "control plans", etc.

That was "OK" up until the point when folks began to use the MVP less as a "validation plan" and more of an "escape route" from having to do validations, re-assessments, or application of control plans. That company did get into trouble with regulators, and the outcome w.r.t. to MVPs was that even the majority of process validations that were well-handled got tainted by those that were pretty clearly not taken seriously.

That experience hinted to me that the people whose first instinct is to not validate "because outputs can be verified" are those people whose playbook relies heavily on "if someone has a problem with us not validating it, we'll just validate it when we have to."

 

[Philip B]

A VMP can be in any format you want provided you control it, same as you would for any other document. I find it useful to have one to summarise the approach to validation and to act as a planner for the current year's validation activities. I re-issue it at the end of the year.

 

[Chrisx]

Although a VMP is probably a good thing, there is no clear requirement in ISO 13485. This makes it difficult to impossible to define what a VMP is or how it is to be controlled. Personally, I have always found this expectation to be confusing. It's certainly a good idea to identify which processes are fully verifiable and which require validation. Certainly it is necessary to locate the supporting validations. However, there are many formats that have been used, due IMO to the lack of a requirement.

 

[Tidge]

I first saw "Validation Master Plan" explained in the GHTF Quality Management Systems - Process Validation Guidance document. There was potential for a little bit of confusion therein, because the term was defined (but not in the "definitions" section) as an over-arching document and then it was almost immediately used in a bullet point list that made it look subordinate to individual processes.

 

[Chrisx]

It is only briefly mentioned in the GHTF guidance without any detail as to what the contents of a VMP should contain. Maybe there is something in pharma guidances?

 

[Tidge]

I think this contains sufficient detail:

Many manufacturers develop what is referred to as a master validation plan which identifies those processes to be validated, the schedule for validations, interrelationships between processes requiring validation and timing for revalidations.

 

[Chrisx]

The GHTF guidance doesn't address any of the questions from the original poster.