Questions On Risk from my recent webinar on the Master Validation Plan:

My response:

 

Ques. 1: How would you structure or link design documentation for a hardware system and the disposable sets used on that system?

Ans: It depends on whether the disposables are your company's designs/ supplied by you, or purchased separately from another company by the user.  If yours, you would address them / their design/risk the same as the basic system, either in the system's DHF, or in additional / supplemental DHF's, referencing the original DHF.  If another company's, you would address your product's interfaces to the outside products, for all that you claim compatibility with, e.g., standard luer fittings, et al, in your DHF / Risk files. 

Ques.2: On Risk Management Files, you say that overall residual product risk is acceptable and that not every residual risk must be disclosed. 

ANS:  If the supporting data, FME[C]As, FTA, et al, show residual risk then you make the determination as to whether the residual risk is acceptable and analyze that conslusion in your Benefit / Risk (to patient/user) Analysis .  All residual risks are shown in the supporting documents, FTA, FME[C]As..., but not all have to be specifically analyzed, only those that pose important risks to the user/patient. 

 

(A) How would you summarize individual risk into an overall product risk?

ANS:  That's a decision your company's product experts would have to determine, and define in your design control DHF / Risk Management File SOP(s).  The overall Product Risk is the sum total of all your product's individual risks from design issues, production failures, and use errors, etc.

 

(B)Would you not disclose your full FMEA document to the FDA?

ANS: Of course you'd disclose it/them..  Your DHF and Risk Management File ( and Human Factors File, if used) are all to be accessible to an FDA inspector, and some may be submitted to the FDA in a Marketing Authorization submission (510(k), De Novo, PMA...) to show your product's risk in general and in relation to a predicate device, or in response to a 483 remediation, or ...

-- jel@jelincoln.com  05/18/2026

 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 (per SOP VVV).

-- jel@jelincoln.com  05/12/2026

- Added a SOP to "Revalidation" - JEL, 05/16/26

-  Note:  As a virtual company, much of the CGMP requirements would be addressed in a Quality Agreement, between the parent company and the CMO, outlining who does what.  However, it is still the parent (virtual) company's responsibility it ensure all CGMP requirements are done. - JEL, 05/25/26