GMP News - APIs and Excipients


ICH Q11 Draft Gelling On Lifecycle/Change Management and Control Strategy Components

The lifecycle management section of the newest working draft of ICH's Q11 guideline on drug substance development and manufacturing provides allowance for applicants to include change management proposals in their original submissions. Read one here.



Revision or Renewal of CEPs: Requirements for Notifications to the EDQM

The EDQM has to deal with an increasing number of deficiencies in the notifications regarding revisions or renewals of CEPs which makes the procedure inefficient and which could be easiliy avoided. Here you can read more about the most common deficiencies found in the documents submitted to the EDQM.



ICH Q7 How to do Guide - Video Presentation of APIC Conference available

During the APIC Conference in Barcelona end of October the new "How to Do" Guide of the APIC, the Association of European API Manufacturers, was introduced and commented. The presentation was recorded, and the video is now available. Read more here.



Frequently asked Question: How do I find all CEPs suspended by the EDQM?

For a number of reasons, for example when an inspection reveals that a production site does not comply with GMP requirements defined in ICH Q7, a CEP for an API can be suspended. Click here to read more about the list of suspended CEP´s and their holders.



GMP Problems cause the Suspension and Withdrawal of further CEPs

GMP compliance problems identified during inspections resulted in the suspension and withdrawal of further CEPs. Go here to read more.



WHO starts Pilot Programme for pre-qualifying APIs

The World Health Organisation (WHO) started a new pilot programme for pre-qualifying pharmaceutical APIs. This programme completes the already existing pre-qualification programme for medicinal products. Find out more here.



The APIC revises the "ICH Q 7 How to do" Document

The APIC's "How to do" Document is one of the most important documents for the interpretation of the GMP requirements for API manufacturers defined in the ICH Q7 Guide. This document was recently revised. Read more here.



MHRA requires active Maintainance of API Manufacturing Sites

Through its inspection programme, the MHRA has encountered numerous examples of API manufacturing sites that are named on marketing authorisations but are not currently used and not fully maintained as approved suppliers. Please go here to read more.



What Is Wrong with APIs from China and India?

API manufacturers from India and China have more and more explaining to do. How is it possible that almost all of the CEPs withdrawn by the EDQM due to GMP inspections come from Asia, especially from India and China? Read more here.



WHO Adopts GMP for APIs from the ICH Q7 Guideline - additional explanations added

In the recently published Technical Report Series No. 957, the WHO revised a number of annexes. For Annex 2 the wording of the ICH Q7 Guideline was adopted as a whole. The appendices that have been added to this annex in order to clarify some important GMP issues are highly interesting. Read more.



Part 2 EU GMP Guide on APIs Will No Longer Be Identical to ICH Q7

The European Commission published a revised Part 2 text on GMP for APIs which will enter into force by 31 July 2010. Click here to read more.



FDA Plans to Revise cGMP Guide Focussing on Outsourcing and Raw Materials

The FDA is going to revise 21 CFR 210/211 as part of their initiative to update cGMP requirements in a stepwise approach. Click here to read more



Comprehensive Study about Verification of GMP Compliance at API Manufacturers published by DMA

On 20 May 2010 the Danish Medicines Agency (DMA) published results of a survey to examine the extent to which manufactureres of medicinal products comply with their obligation to ensure that APIs used in the manufacture of medicinal products comply with the GMP regulations. A number of deficiencies have been identified which need to be remedied in the future. You will find more here.



New Template for Drug API Quality Agreements

The Bulk Pharmaceuticals Task Force (BPTF)* has developed and published a Quality Agreement template. Read more.



Further CEPs suspended and withdrawn by EDQM

The EDQM continues to inspect manufacuturers of APIs - especially in Asia. As a consequence further CEPs were suspended or withdrawn. You will find more information here.


GMP Newsletter

Sign up for the free of charge newsletters.

Sign up now!

GMP Conferences by Topics