Some European Companies Selling in the US Aren't Playing By the Rules

As a consultant working with clients all over the world, I sometimes get push-back to a recommended action using reasoning similar to the following:

Most of the pharma facilities in this area are not following the cGMP rules, even though they sell to USA market.  This happens when if they bring in new equipment. The facilities here are almost 20-30 years old and they all seem to have the understanding that if they print the batch record on a paper then they are free from Part 11 requirements. They don't do cleaning after each run.  They claim they only use a paper system, and aren't under 21  CFR Part 11. Some companies are doing API manufacturing in a non-sterile environment, not good aseptic processing . Some are installing new equipment, but with no proper (or only haphazard)  verification / validation, and many other non-conformances. It doesn't appear that the FDA has been here for inspections. So, if my competitors are not obligated to follow the cGMPs, why should I?

I usually answer similarly to the following:

If the companies sell in the US they are required to follow the US FDA CGMPs for their
industry, e.g., 21 CFR 820 for devices, and 21 CFR 210, -211plus for drugs.  They don't need 

to follow 21 CFR11 if they used paper records and manual signatures, BUT all their people 

have to do that.  If some are using the e-records / e-signatures to do CGMP activities / 

records, then it doesn't matter what they say their policy is, they're viewed as under Part 11 

by the US FDA.  

The FDA has 11 resident posts located world-wide, outside the US, 3 in mainland China.  They

are still backlogged due to COVID19 in inspections, and they base the frequency of

those inspections on the company's products' risk to patient.  But I have worked with some 

EU companies that have had US FDA inspections and gotten Warning Letters, ditto Asia, so 

the FDA is currently inspecting some companies in the EU and Asia.  Those companies had 

previously had greatnotified body audits, incidentally.  The CGMP disconnects I see are usually with the biggest 

problems in CAPA, Trending, andthe definition of risk (the FDA focuses on patient safety, many EU and Asian companies also include      

financial, regulatory, schedules under risk as well).  I see a lot of problems with V&V all over the 

world, including in the US.Some validations not holding variables constant, e.g., with written P/Ns and specs, change control,

key variables not validated, no predetermined acceptance criteria set before running the V&V, et al.

Sad to say, I see the same things that you've mentioned.  As a consultant, I usually get called after 

an FDA Inspection, when the company gets a lot of 483 observations and/or a Warning Letter for

for things they should have been doing all along but weren't.

Some current Covid 19 vaccine start-up production issues, drug 

shortages, and baby formula shortage problems here in the US were due to failures in cross-

contamination controls, basic CGMPs. In some cases, they've been misinformed by another consultant.

I try to educate such companies and their personnel, but some feel I'm only requiring some document

to "pad my fee", so, sad to say they'll find out the hard way when they finally are inspected and get a 

Warning Letter, or are shut down after some of their customers in the field get sick or die.

-- jel@jelincoln.com