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ICHQ7 & Q11 (2 of 7)

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This document discusses an interactive discussion forum on ICH Q7 and Q11 guidelines for good manufacturing practices. The discussion focused on whether a drug product can ensure safety if manufactured from a non-compliant active pharmaceutical ingredient. Participants also considered whether good manufacturing practices are required for pharmaceutical ingredients, processes, and products.

Discussion Forum on ICH Q7 & Q11
Interactive Opening Discussion
Dr. Obaid Ali
Deputy Director, DRAP
Member ISPE, PDA
23 April 2017 (Program A)
21 May 2017 (Program B)

Interactive Opening Discussion
Q7 Q11

ICHQ7 & Q11 (2 of 7)

ICHQ7 & Q11 (2 of 7)

Ingredients Process Product

Can a drug product manufactured from a
non-compliant API ensure safety???

SM IM API Excipients
Capsule
shell
Is GMP required? Yes / No

ICHQ7 & Q11 (2 of 7)

More Related Content

ICHQ7 & Q11 (2 of 7)

1. Discussion Forum on ICH Q7 & Q11 Interactive Opening Discussion Dr. Obaid Ali Deputy Director, DRAP Member ISPE, PDA 23 April 2017 (Program A) 21 May 2017 (Program B)

2. Interactive Opening Discussion Q7 Q11

5. Ingredients Process Product

6. Can a drug product manufactured from a non-compliant API ensure safety???

7. SM IM API Excipients Capsule shell Is GMP required? Yes / No