GMP NEWS 2013

The European Commission has published the revised Chapter 2 on Personnel, which will come into operation on 16 February 2014. The basic principles of the chapter have been unchanged; however a few new approaches have been added. Read more.

The EDQM maintains a database that contains the relevant information about the Certificates of Suitability (CEP). Read more about the changes in the CEP database.

The EMA Guideline on the use of bovine serum in the manufacture of human biological medicinal products will come into effect at the end of 2013. Read more here.

Scientists at the U.S. Food and Drug Administration (FDA) have reported that studies performed in animals provide a proof of a concept that transfused UV-light damaged PLTs can mediate lung injury. Read more.

The APIC has published a guideline for the management and the qualification of contract laboratories. The guideline is supplemented by detailed checklists and questionnaires, which are very useful for practice. For more information read this news.

Frequently we receive questions with regard to the various inspection reports of the U.S. Food and Drug Administration (FDA). For that reason you can now find explanations to the three most important documents in this news.

Testing active pharmaceutical ingredients, excipients and packaging materials is one of the main tasks of the quality control units in the pharmaceutical industry. But how to reduce testing and comply with GMP? Read more in our GMP News

In July the WHO has published a revised version of their Guideline "Good Manufacturing Practices for Pharmaceutical Products: Main Principles" for comment. Read on.

There are no specific provisions regarding the traceability of medical devices in the European regulatory framework for medical devices. That’s why the EU Commission has now published "Recommendations on a common framework for a system of unique product marking for medical devices". Read more.