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May 2011

NEW US FDA guidance document on submission of summary Bio-equivalence data -FDA guidance document.
USP general chapter under revision in US PF 37 <3> - Elemental impurities- Limits & Procedure; Loss on drying -
Warning letter issued to Teva pharma -
Questions & Answers document regarding Distribution Activities for Active Pharmaceutical Ingredients (APIs) -

April 2011 viewed 10000 times. cGALP team thank to all readers for your support. Put your comments in guest book

New FDA draft guidance Document on “Dedicated facilities”-  Click draft of the new guideline.

Note for guidance on minimizing the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products (EMA/410/01 rev.3)  -note for guidance
EDQM - new draft general chapter - 2.9.47 entitled "Demonstrating of Uniformity of Dosage Units using Large Sample Sizes". – Abstract view here.
US FDA Warning letter – Ningbo smart pharmaceuticals 

March 2011

EMA plans for revision of EU GMP guide click for details

New US FDA guidance document for the calender year 2011. For complete list

Impurities:-Guideline for residual solvent Q3C(R5) finalised - You can find the new Guideline Q3C(R5) -Residual solvent

Warning letter to Sanofi Aventis - WL 

USP revised the general chapter <85> Bacterial Endotoxins Test
February 2011

A new ICH concept paper on Q3D -Impurities - Guideline on metal impurities.This new guidance is proposed to provide a global policy for limiting metal impurities qualitatively and quantitatively in drug products and ingredients. click for concept paper 
A new USP general chapter <1224> on Transfer of analytical procedure is proposed. To view login free in pharmacopeial forum
USFDA released statistics on cGMP deficiencies cited during inspection for the year 2010. To know top deficiencies click 

January 2011
cGALP -First anniversary on 14-January -2011. Thanks to all readers.
Process validation - US FDA guidance for industry released - Revision 1 - To read visit home page. 
US Pharmacopeial forum free online from January 2011- To log on register USPPF login 
The ICH Quality Implementation Working Group (Q-IWG) has issued volume 4 of the ICH guideline Q8, Q9 and Q10 - Questions and Answers Document
New EU GMP Guide Annex 11 "Computerised Systems"  & Chapter 4 "Documentation"
In Europe the EU GMP Guide Annex 11 "Computerised Systems" is the regulatory basis for GMP regarding IT systems in the pharmaceutical industry. The new version was issued on 3 January 2011 together with the EU GMP Guide Chapter 4 "Documentation". It will become effective on 30 June 2011.
FDA launches website to help regulated industries save time, resources
The U.S. Food and Drug Administration today introduced a new Web resource called FDA Basics for Industry ( to help companies and others save time and resources in their interactions with the agency.
The website includes basic information about the regulatory process, including information that is frequently requested by industry.

To see the previous year news click archival 


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