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Questions & Answers document regarding Distribution Activities for Active Pharmaceutical Ingredients (APIs) -

EDQM - Q&A on reference standard
The ICH Quality Implementation Working Group (Q-IWG) has issued volume 4 of the ICH guideline Q8, Q9 and Q10 - Questions and Answers Document
This Questions and Answers document (Q&A) refers to the current working procedure of the ICH Q-IWG on implementing the guidelines of Q8, Q9 and Q10 which have been approved by the ICH Steering Committee.
The benefits of harmonizing technical requirements across the ICH regions can only be reached if the various Q-ICH guidelines are implemented and interpreted in a consistent way across the three regions. Implementation Working Group is tasked to develop Q&As to facilitate implementation of existing guidelines.

References ICH Q8(R2)

Pharmaceutical Development

Part I: ‘Pharmaceutical Development’

Part II: ‘Annex to Pharmaceutical Development’

Aug. 2009
Nov. 10 2005
Nov. 13 2008


Quality Risk Management

Nov. 09 2005


Pharmaceutical Quality Systems

Jun. 04 2008

EMA Q&A on Post Approval Change management protocol
Q & A on Guideline on the limit of genotoxic impurities by EMA
MHRA -Good Manufacturing Practice (GMP) - Quality risk management: Frequently asked questions - MHRA_Quality Risk Management_FAQ
FDA Q&A on Current Good Manufacturing Practice for Finished Pharmaceuticals

ICH Q&A on Q8, Q9 & Q10
This is a ICH Q&A section on quality guidelines of pharmaceuticals development, quality risk management & pharmaceuticals quality. For download click ICH - Q&A - Q8, Q9 & Q10
EMEA publishes the answers to frequently asked questions on GMP following discussion and agreement of the GMP/GDP Inspectors Working Group. For download click EMA-GMP-Inspections
This is a standards frequently Asked Questions to USP. For view click USP -Standards -FAQ

FDA Q&A - Residual solvents
This is FDA Q&A on revised USP general chapter<467> with respect to information of residual solvents in ANDA submission.

The USP Q & A is collected from USP monthly newletter which are relevant to Pharmaceutical quality control laboratory. For detailed information click link
Question - April - 2011

How can I tell if a monograph in USP 34 has changed from USP 33 Reissue?

Look in the Front Matter section of USP 34 under USP Annotated List to see General Notices, Monographs, General Chapters, Reagents, and Tables Affected by Changes Appearing in USP 34 .

Question - March -2011

Why didn’t I receive the January–February issue of Pharmacopeial Forum (PF 37(1))?

It is now a free online-only service. Learn more and access the new PF today!
(Please note: a one-time, free registration is required.)
Question - February - 2011
How can I tell if a particular monograph is harmonized?
Answer: For monographs or chapters that are completely harmonized no indication is given in the monograph or chapter, check General Chapter <1196> for the status and ICHQ4B Annexes for regulatory interchangeability. For monographs or chapters that are harmonized by attributes, an explanation can be found at the beginning of the monograph or chapter.
A USP webpage on harmonization is coming soon. The page will have an updated list of harmonized chapters and monographs, as well as links to sign-off cover pages which will list non-harmonized attributes and harmonized attributes
Question - January -2011
When is USP 34–NF 29 official?
Answer:USP 34–NF 29 is official May 1, 2011.

For previous year's USP Q & A click archival
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