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Back to the forum  Query: 2017-12-11 18:21 CET (UTC+1h)
 
Helmut
Hero
Homepage
Vienna, Austria,
2017-03-03 11:42

Posting: # 17124
Views: 1,284
 

 GMP: EMA and FDA – mutual recognition of inspections [GxP / QC / QA]

Dear all,

regulators in the European Union (EU) and the United States (US) have agreed to recognize inspections of manufacturing sites for human medicines conducted in their respective territories on both sides of the Atlantic – see yesterday’s press releases (EMA, FDA) and the full text of the agreement.

[image]Regards,
Helmut Schütz 
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The quality of responses received is directly proportional to the quality of the question asked. ☼
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nobody
Senior

2017-03-03 16:15

@ Helmut
Posting: # 17129
Views: 1,049
 

 GMP: EMA and FDA – mutual recognition of inspections

...to avoid double-inspections and put more focus on other regions.

Kindest regards, nobody
Helmut
Hero
Homepage
Vienna, Austria,
2017-11-10 11:19

@ Helmut
Posting: # 17969
Views: 392
 

 USA ⇔ AUT, ESP, FRA, GBR, HRV, ITA, MLT, SWE

Dear all,

the EC already confirmed that the FDA has the capability, capacity and procedures in place to carry out GMP inspections at a level equivalent to the EU.
With November 1st, the FDA confirmed the capability of eight EU Member States (Austria, Croatia, France, Italy, Malta, Spain, Sweden, and United Kingdom). The remaining inspectorates will continue to be assessed until 15 July 2019. See also the EMA’s press release.

[image]Regards,
Helmut Schütz 
[image]

The quality of responses received is directly proportional to the quality of the question asked. ☼
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ElMaestro
Hero

Denmark,
2017-11-10 19:10

@ Helmut
Posting: # 17970
Views: 370
 

 GMP: EMA and FDA – mutual recognition of inspections

Hi all,

I am so worried because of all this.

They make it sound like unnecessary inspections are the big problem and that this agreement is the method to get rid of the problem. It sounds right, sensible use of resources, almost LEAN, tax payers money at work, blahblahblah.

But in fact I have never heard of unnecessary inspections, not even when FDA and EMA 'by chance' have been at the same place more or less simultaneously. Especially not when FDA and EMA 'by chance' have been at the same place more or less simultaneously, actually.

I am totally afraid this means less inspections overall, and that would absolutely be a step in the wrong direction. Fraud is on the rise and it is big business - as it is now, it makes good sense to cheat or cut corners because the chance of getting caught is small to state it bluntly. The financial gain is extremely high, unless you just happen to be unlucky enough to get caught.

You will see me happy and singing and dancing when I see inititative towards
  • more inspections (more inspectees per year)
  • more frequent inspections (more inspectinos per inspectee per year)
  • more inspections taylored towards the type of corner-cutting that we have recently among producers and CROs recently (and note the present agreement doesn't cover anything beyond CMC).
  • guidelines that force rather than suggest the industry to up the game in terms of vendor oversight.
A good weekend to all of you.

I could be wrong, but…


Best regards,
ElMaestro

A potentially biased estimator may be a relevant estimator. The case of REML speaks volumes.
DavidManteigas
Regular

Portugal,
2017-11-14 15:47

@ ElMaestro
Posting: # 17980
Views: 285
 

 GMP: EMA and FDA – mutual recognition of inspections

Thumbs up for El Maestro post! :clap:

Although I may understand the cost issue, I can't understand why pharmaceutical companies that outsource most of their R&D and manufacturing activities don't think and behave as you've described. They should be as interested as the regulatory authorities in assuring that the highest standards are followed by their vendors. When something goes wrong, and as the "vigilance" decreases the probability of lack of compliance increases, it's their brands and products that feel the consequences, as well as the market as a whole. Unless they all believe that there isn't such thing as bad publicity.
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