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 How is it possible that almost all of the CEPs withdrawn by the EDQM due to GMP inspections come from Asia, especially from India and China?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.
On the web page of the WHO Prequalification of Medicines programme, public inspection reports (WHOPIR) are published. A WHOPIR reflects the inspection report and gives a summary of the observations and findings made during the inspection, mainly at sites in India and China. Read more.
The relevant guidelines on stability testing of active pharmaceutical ingredients and finished medicinal products provide hardly any information on the stability data of pharmaceutical bulk products that have to be included in the dossier for a marketing authorisation. Now the EMA gives answers to the most important questions in its Q-and-A section. Read more here.
The Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human, CMD(h) has published an updated version of its Q&As on Variations according to Commission Regulation (EC) 1234/2008. In the latest revision, a question regarding pharmacopoeial updates was added. Read more.
In Vol. 75, No. 121 of the Federal Register, the FDA announces the inclusion of remanufacturers of hospital single-use devices in the cGMP/QS rules (21 CFR 820). The FDA intends to bind the remanufacturers fully to the requirements. Read more here.
Jean-Marie Geoffroy, PhD, from Takeda Global Research & Development, USA, explains which factors are important in order to achieve modern concepts of process validation or even continuous verification instead of traditional process validation. You'll find further information here.
With the revision of the WHO Technical Report Series No. 957 in June 2010, the WHO has also published a new Annex 7 "Guidelines for the preparation of a contract research organization master file". Read more.
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.
The US Food and Drug Administration, FDA issued a draft guidance for industry, CMC Postapproval Manufacturing Changes Reportable in Annual Reports, providing recommendations to drug applicants about the types of changes that may be included in annual reports. Read more.
The USP General Chapter 1050 - "Viral Safety Evaluation of Biotechnological Products Derived from Cell Lines of Human or Animal Origin" is under revision. After 10 years, the document will be updated now with respect to the developments in the field of viral clearance. Read more here.
The Danish Medicines Agency (DKMA) is running a web page on FAQs on Annex 13 of the EU GMP Guide (Manufacture of investigational medicinal products). One interesting Q&A is dealing with validation of critical manufacturing processes. Read more.