Why ICH-Q7 Guideline not revised from Nov-2000

GOOD MANUFACTURING PRACTICE (cGMP)
1

Dear All,

I have one drought, why ICH-Q7 Guideline not revised/ updated from Nov-2000 onwards, is any equal or better guideline available for ICH-Q7

Regards,
Murali krishna Reddy

2

Many documents pertaining to Quality systems, Traceability, Drstribution, Storage, Supplier qualifications which are primary pillars to ICHQ7A were updated and even new additions were published.
Q7A is the base. You need to look other documents too.

3

you can use EU GMP Guide Part-II

Please see the attachment.
[attach]520[/attach]

EU GMP GUIDE PART-2.pdf (451.5 KB)

4

There is a ICH Q7A discussion document. It runs for about 90 pages. It tells you what to do and what not to do. It gives a better explanation and detailed references.

5

thank you sir,