What about GMP/GxP for Medical Devices?

For anyone working with Quality Management in the pharmaceutical industry the abbreviation GxP  is very familiar. In the European regulatory environment for Medical Devices, those abbreviations are not so commonly used.
The Medical Device industry in the US on the other hand may be more familiar to them. The Quality System requirements for medical devices is actually also called CGMP (21CFR 820 Quality system Regulation/Current Good Manufacturing Practice).

In a similar way, if you do preclinical studies evaluating the safety of a device, the FDA in certain cases expects firms to comply with Good Laboratory Practices for those studies .
Also coming to the Clinical evaluation of Medical Devices, in the same way, FDA refers to Good Clinical Practices .

Even though the terminology may differ between US and EU, the Regulatory systems still has a lot in common. All data generated to support the safety claims for a medical device of course has to have integrity and be trustworthy.
The ISO 10993 (Biological Evaluation of Medical Devices) series of standards has a lot in common with the GLPs in the US. And of course clinical evaluations or clinical studies involving human subjects and performed to support the CE marking of a Medical Device in EU cannot be done without ethical considerations and stipulated permissions in place .

Coming back to the comparison between Quality Management Systems and GMP,  the recently updated version of ISO 13485:2016 now has very much in common with other international regulatory requirements especially the 21CFR820. So even though GxP or GMP still may be unrecognized in Europe for Medical Device companies, the general concept of quality management has become more and more internationally harmonised.

So in general, the regulatory framework and the different guidelines about how to comply with the legal requirements, have a very similar setup even though terminology may differ.

GMP for Medicinal products QMS for Medical Devices

#qualitysystem #qualitymanagement #gmp #gxp


Do we have a problem with Quality within the pharmaceutical industry?

One could think that high quality is a significant attribute within the pharma and medical device industry but is that really true?

I recently read an article in the PDA Letter1 that 64% of the drug shortages in the USA were caused by quality issues. I also saw an interesting benchmark in Pharmaceutical Engineering2 (ISPE) where Pharma was compared to Automotive, Aerospace, Computer and Consumer Packaged Goods industries in several areas that was honestly quite depressing, i.e. “First-pass yield – zero defects” in Pharma was 60% compared to 90-99% in all other sectors except Aerospace (70-90%).

I do not have a good answer why this is the case but I strongly believe that a “better” attitude towards GMP and quality is needed. I still see organizations where QA and Production almost fight each other – Production blames QA for slowing them down and putting unrealistic demands on them and QA blame Production for not documenting properly or doing good enough investigations. I also do see good examples of course and I will spend some time in a future Blog post to discuss that.

What do you think about the Quality Mindset within you own organization? How would you grade it on this scale?



Anna Lundén

Anna Lundén
Training manager and part owner
Key2Compliance AB

1 PDA Letter, Nov/Dec 2014, page 41-42
2 Pharmaceutical Engineering, Sep/Oct 2014, page 42



New guideline releases in EU

March 19 EUR-Lex published two new guidlines we have been waiting for - the GDP for API and the GMP for Excipients.