As detailed in my other related posts in this Forum, FDA for example has made it clear that it requires process verification/validation to be completed before design release. In a nutshell, there appears to be no FDA regulatory (or ISO) provision made for "limited commercial release". Indeed, such a release is in my opinion just an invention of an overly pressured engineering or sales agenda. Not only does such an approach seem to contravene regulatory requirements, but I've seen time and again that it's a fabulous recipe for cooking up costly and embarrassing recalls.
From a pure regulatory standpoint, there are only two statuses for a design: released and unreleased. To be released, all of the design control tasks through design transfer need to be completed. Releasing product into the marketplace before its manufacturing process is verified and/or validated would be a clear violation of the associated FDA regulatory (and ISO) requirements, and consequently an opportunity for a potentially serious FDA 483 Observation or ISO Nonconformity. Via my various other design control posts in this forum, I've recited the clear regulatory bases for the unequivocal FDA regulatory (and ISO) requirement that manufacturers pursue and finish the design and development of the device and the manufacturing process prior to product release. FDA's interpretation of the design control regulation doesn't permit us to declare the verification/validation activities finished until the product and process verification/validation activities are complete. Although it is often logistically necessary to pair process verification/validation activities with design transfer, FDA has repeatedly shown that it considers process verification/validation to be part of the overall design verification/validation. If process verification/validation isn't finished yet, then design verification/validation isn't finished yet.
If there is any traction possible for the "limited commercial release" concept, then it would lie in the degree of verification/validation. Specifically, if the statistical rationale for the process verification/validation sample sizes is defensible commensurate with the risk and complexity of the product and process, then that could be a possible avenue. But for such an approach to survive regulatory (and common sense) scrutiny, it must be possible to conclude that no further verification/validation is needed at all to assure the production of consistently safe and effective medical devices. If the safety profile of the product and process demand further verification/validation than what was done to support the "limited commercial release", then it would be an intrinsic indication that the initial verification/validation was incomplete and insufficient to justify any form of release.
Hope this helps.
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Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
ComplianceAcuity, Inc.
Golden, CO
United States
www.complianceacuity.com© Copyright 2019 by ComplianceAcuity, Inc. All rights reserved.
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Original Message:
Sent: 09-Dec-2019 10:57
From: Anonymous Member
Subject: Limited Commercial release - place in design control flowchart
This message was posted by a user wishing to remain anonymous
Hello,
I am struggling to understand if Limited commercial release can be added in the design control flowchart. Is Limited commercial release really a part of design control? If yes, where in the process it may fit in?
My colleagues wants to add it in between verification and validation completion and design transfer. I see Limited commercial release as any other release and am a bit hesitant to add it in the design control process flowchart. If it has to be added it should be after Design transfer (Product release) has happened, in my view point. However, the argument here is that for a one product company where the manufacturing is of a very small scale - manufacturing process validation and design transfer does not happen immediately and takes time and the commercial team should be able to sell the product once the verification and validation activities are complete.
Has anyone else faced a similar situation? Any thoughts/suggestions on what should be done to help the commercial team, however, still be confident that we are not falling under the non-compliant category?
Thanks in advance!