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Similarities and Differences between EU & US GMPs (Good Manufacturng Processes)

V

vsankar

#1
Can anyone explain me the similarities and difference between the EU and US GMPs???
please send me some short notes so its easy for me to understand.

Thanks in advance
 

Ronen E

Problem Solver
Staff member
Super Moderator
#2
Can anyone explain me the similarities and difference between the EU and US GMPs???
please send me some short notes so its easy for me to understand.

Thanks in advance
Hello and welcome to the cove :bigwave:

What industry are you in - medical devices / pharma / food / cosmetics / other? That would help in providing a more focused response.

Cheers,
Ronen.
 

sagai

Quite Involved in Discussions
#3
One of the major difference is in the EU the QMS requirement is on ISO standard level and enforced by public companies (auditor firms) but in the US it is a law and enforced by governmental Agency (FDA).
The other radical difference is that for document and record control the requirements are more rigorously set forth in the US.
Well, on this general level, these would be my two cents.
Regards
Sz.

PS.: P is actually for Practice, not for Process.
 
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V

vsankar

#4
Similarities and Differences between EU & US GMPs (Good Manufacturng Processes)

I am in Pharmaceutical industry. i need full information about this step by step.
 
Last edited by a moderator:

sagai

Quite Involved in Discussions
#5
I tend to suggest to find training around your location.
It is such a huge subject and simple with a yes/no checklist can not be effectively transferred such gasoline of information.
Regards
 

bio_subbu

Super Moderator
#6
Similarities and Differences between EU & US GMPs (Good Manufacturng Processes)

I am in Pharmaceutical industry. i need full information about this step by step.
I don't have detailed comparison chart but below links would be helpful to you..

EU EudraLex - Volume 4 Good manufacturing practice (GMP) Guidelines

USFDA TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER C--DRUGS: GENERAL PART 211 CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS

ICH ICH Guidelines Q7- GOOD MANUFACTURING PRACTICE GUIDE FOR ACTIVE PHARMACEUTICAL INGREDIENTS

Regards
S.Subramaniam
 
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