Failure to Comply With CGMPs Equates to Adulterated Products in the Eyes of FDA!
The doctor is on an extended road trip this week so Dr. D will be brief, but hopefully entertaining, in this week’s guidance. I know the old doctor has pontificated in multiple blog articles on the importance of CGMPs and their application to support the design, development, and manufacture of medical devices that are safe and effective in their intended use. However, maybe the doctor’s message of compliance is just not reaching the correct audience.
People, what part of CGMPs are required for the design, development, and manufacture of medical device that are safe and effective in their intended use is not being understood? Seriously, this past week, FDA posted another warning letter with seven Form 483 observations noted. However, the real attention grabber was the following paragraph Dr. D extracted from the warning letter.
“This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act (21 U.S.C. § 351(h)), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.”
Although many readers may believe that discussing the virtues associated with CGMP requires some “sempiternal” (look-it-up) debate, the agency just isn’t in the debating mood. Remember, there is no such thing as minimum compliance or maximum compliance; there is just compliance. Enjoy!
Warning letter – 10 October 2014
As mentioned in the opening paragraph, this week’s winner of FDA’s warning letter sweepstakes received seven form 483 observations that essentially threw:
- CAPA – §820.100;
- Complaint Management – §820.198 (two observations);
- Process Validation (PV) – §820.75;
- Process Control – §820.70;
- Purchasing Controls – §820.50; and
- Control of Nonconforming Product – §820.90; under the big bus.
Considering CAPA, complaint management, PV, ongoing process controls, purchasing controls, and the handling of non-conforming product are salient requirements for an effective Quality Management System (QMS); there really is not much remaining. Dr. D is left wondering how such an establishment can be operating in the medical device space; just maybe toys are an option.
Compliance for dummies
I guess Dr. D could grab a ladder and climb onto his proverbial pulpit and start preaching but at times it feels like the message is falling on deaf ears. That being said, it is Dr. D’s humble opinion, all device establishments should hold annual refresher training for CGMP compliance. In fact, every-single member of a device establishment’s organization should participate in the refresher training. Why? Because sometimes the message of ongoing compliance is lost. All industry professionals, and the doctor uses the word “all” quite loosely; understand the need to sustain compliance to remain in the good graces of our friends at the agency.
In general, most device establishments, and once again the doctor uses the word “most” loosely; understand the importance of training employees to ensure CGMP is effectively maintained on a day-to-day basis. If your organization does not have a training program that reinforces the behaviors required for effective CGMP, Dr. D strongly suggests that such a training program is implemented, ASAP! In fact, if you need a presentation, please contact Dr. D. The doctor is sure he can find one for you.
Takeaways
For this week’s guidance the doctor will leave just on takeaway. It is not acceptable to have a QMS that does not support CGMP compliance. In fact, if an organization fails to practice CGMP compliance, chances are good that either the QMS is poorly constructed or the management team is clearly disconnected from the QMS process.
In closing, thank you again for joining Dr. D and I hope you find value in the guidance provided. Until the next installment of DG – cheers from Dr. D. and best wishes for continued professional success.
References:
- Code of Federal Regulation. (2013, April) Title 21 Part 820: Quality system regulation. Washington, D.C.: U.S. Government Printing Office.
- Devine, C. (2011). Devine guidance for complying with the FDA’s quality system regulation – 21 CFR, Part 820. Charleston, SC: Amazon.
- Devine, C. (2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon.
- FDA’s enforcement page. (2014, October). FDA.gov Website. Retrieved October 27, 2014, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm418730.htm.
Related Articles
-
The draft guidance proposes updates to clarify how the Breakthrough Devices Program may be applicable to certain medical devices that promote health equity, as well as considerations in designating eligible devices that may benefit populations impacted by disparities in health…
-
The updated guidance document clarifies what constitutes a statement of the basis for the deficiency and includes examples of well-constructed deficiencies and industry responses to facilitate a more efficient review process.
-
The new guidance is intended to establish confidence in automation used for production or quality assurance systems and describe various methods and testing activities that may be applied to establish computer software assurance and meet regulatory software validation requirements.
-
Manufacturers preparing premarket submissions should provide performance specifications for the quantitative imaging functions, supporting performance data, and sufficient information for the end user to obtain, understand and interpret the values provided.
