For practical intents and purposes, remember that 21 CFR part 58 and the GLP requirements therein become mandatory only when three criteria are met:
- the studies are non-clinical laboratory studies performed on animals, plants, microorganisms or subparts thereof;
- the purpose of the studies is to characterize the safety of the product;
- the studies are submitted, or are conducted for submission to, the FDA in support of an investigational or marketing approval/clearance.
If the studies do not meet these three criteria, then they are outside the intended scope of the GLP regulations.
Accordingly, GLP controls aren’t required for routine bioburden studies, assuming that “routine” means post-clearance/approval studies performed to periodically monitor the bioburden of either a) manufactured devices and/or b) the manufacturing environment. Instead, it is more appropriate to apply controls such as ISO 11737-1 (Sterilization of health care products—Microbiological methods—Part 1: Determination of the population of microorganisms on product); and if applicable, the ISO 14644 series of environmental/cleanroom standards (or something similar that standardizes environmental bioburden monitoring / air sampling).
Although each compliance scenario needs to be carefully considered on its own merits, the application of standards like ISO 11737 and 14644 is, in all likelihood, sufficient to satisfy the manufacturing control requirements of 21 CFR 820.70 (and/or the ISO 13485 analogs).
Finally, remember also that medical device manufacturing/environmental “validation” [as carefully and deliberately defined by the FDA in 820.3(z)(1)] is only required when the thresholds of 820.75 are met. This is a significant difference when contrasted with the more liberal usage of the term “validation” for drug GMP. Admittedly, it is sometimes of value to perform device process "validation" voluntarily. But due to the inherent rigors of process validation, a device firm’s bottom line is usually best served by ensuring that manufacturing “validation” [820.3(z)(1)] be limited to processes meeting the 820.75 threshold, rather than pursuing such rigors for all 820.70 processes.
Hope this helps,
------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Canada, Europe)
Principal Consultant
ComplianceAcuity, Inc.
Golden CO
United States
Copyright 2016 by ComplianceAcuity, Inc.
Original Message:
Sent: 04-26-2016 12:21
From: Bobbi Siddoway
Subject: GLP Requirements
The question has come up on whether or not we need to be using GLP for our routine bioburden and dose audit monitoring for our Class 11 orthopedic implants. Any help would be greatly appreciated.
Thank you,
------------------------------
Bobbi Siddoway
Regulatory Specialist
West Jordan UT
United States
------------------------------