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.
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'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.
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 How is it possible that almost all of the CEPs withdrawn by the EDQM due to GMP inspections come from Asia, especially from India and China?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.
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.