2006-05-19 09:56
(6641 d 15:51 ago)

Posting: # 129
Views: 14,355

 GCP Guidelines [Regulatives / Guidelines]

Dear Sir,

I would like to go through various GCP guidelines issued by different regulatories like ICH, WHO, EU etc.....

I will be very thankful to you, if can you provide such infomation on this site.
Vienna, Austria,
2006-05-19 15:25
(6641 d 10:23 ago)

@ patel_prakash79
Posting: # 131
Views: 11,537

 GCP Guidelines

Dear Prakash!

You made a valuable suggestion.

But unlike BA/BE, which is generally covered only in guidelines (except - as always - in the USA and Brazil), GCP is part of the legal framework in many countries.

This has some drawbacks for interested 'outsiders':
  • national medicines acts are published only in the national language(s) of the countries,
  • may not be available online,
  • may not even exist in a consolidated version (i.e., the last update may contain phrases like 'Article 7, Section 2, Paragraph 3, last sentence is replaced by ...'), which renders the entire text useless unless you have access to all previous versions.
Anyhow, I will add links to some documents (ICH, WHO,...) to the guidance page within the next couple of weeks.

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