GMP NEWS 2010

Chapter 6 of the EU GMP Guide provides general guidance on the Quality Control Department and Good Quality Control Laboratory Practice. EMA's Concept Paper on the Revision of Chapter 6 recommends that this chapter should be reviewed and that guidance for the transfer of analytical methods from one laboratory to another should be included. For more information please go here.

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.

The European Guideline on the Investigation of Bioequivalence came into effect on 1 August 2010. Further details can be reviewed here.

A recently introduced quality management model discusses new processes and their compliance with international developments and governmental expectations as e.g. expressed in the ICH Q10 guideline. Read more.

Together with Health Canada, the Canadian health authority, the FDA has published a report evaluating a pilot programme of third party audits of medical device manufacturers concerning the reduction of resources. Read more here.

Chapter 5 "Production" of the EU GMP Guide has been revised and was recently published on the European Commission's GMP-information page. The changes offer some surprises and concern the points 5.25, 5.26 and 5.27 on the qualification of suppliers of starting materials.... read on  here.

Dated September 2010, the International Society of Pharmaceutical Engineering (ISPE) has published a new baseline entitled "Risk-Based Manufacture of Pharmaceutical Products" (Risk-MaPP). The title implies a broader field of application than actually described in the baseline - read on for more details...

To address some of the so far not adequately addressed issues in the quality control environment the ECA Foundation decided to establish a new Working Group on Analytical Quality Control. Please read here for further details.

The ISO Technical Committee 209 has been working on a revision of the ISO standard 14644-1 for the last four  years to adopt it to current industry thinking and requirements. After a meeting in Oktober 2010 now there are the first news availibe, mentioning the points likely to be changed. The points under discussion will affect all clean rooms used in the pharmaceutical industry as the FDA Aspectic Guide and the EU GMP Annex 1 refer to this standard. Read more.