Questions from one of my recent webinars on Validation Master Plans:

My responses:

Ques:  Attendee Query: 

“I asked two questions in the session chat and was hoping to have them answered live. Since that did not happen, could you please provide the answers via email? 

I work for a virtual company. As a virtual company, are we required to write our own Master Validation Plan, or can we rely on our CDMO’s Master Validation Plan? 

 Ans:  Sorry, I never saw these questions. The short answer is you can do either.  However, Virtual or not, if you are the top level company, you are ultimately responsible to the FDA for all the CGMP compliance, even if you contract / PO / or Quality Agreement that out to a CMO (Contract Manufacturer). So you have to continually monitor and periodically audit for compliance with those you contact to do the actual work to insure that they do it and are in compliance while doing it. And/or do yourself what's lacking.

Ques:  Do we require a Master Validation Plan for commercial packaging validations?

Ans:  Yes, fhe MVP should include any packaging equipment and its software. However if contracted organizations have their own MVP you can reference them in your's without going into further details, but have to ensue they are following their plan.  As mentioned in the webinar, someone's MVP should address all validatable (per FDA) systems in the company / under the company's product's requirements / needs / control, and how you address them, e.g.,  by validation per an SOP(s) (cited), or by calibration (per SOP), or by Preventative Maintenance, or User Standardization, or contracted, or some combination of those.

Ques:  If a Master Validation Plan is required for a virtual company, do you have a template we can use?

Ans:  One was provided in the webinar.  However, here it is, as a suggestion, as the FDA doesn't specify a specific format / content:

 

VMP / MVP -– A  Typical  Entry:

 

Production / Test Equipment [Description]:

•  V&V per SOP VVV

•  Software / Firmware V&V per SOP FFF

•  Annual V&V Review per SOP VVV

•  Maintain State of Validation and Statistical Control (DHR reviews,  

      CpK studies, Control Charts …) per SOP SSS

•  Calibration Program per SOP CCC

•  PM Program per SOP PPP  …

•  Revalidation, if / when required.

-- jel@jelincoln.com  05/12/2026