GMP NEWS 2015

In the Pharmacopeial Forum the USP has described the future requirements for packaging materials made of plastics. The original proposals were now revised, and new proposals were published with regard to the structure and content of the General Chapters on packaging materials made of plastics. For more information please see the Update of the USP Requirements.

In an EDQM paper published in March 2015 the topic production of WFI by means of membrane-based technologies is discussed again and not excluded any more. Read more about WFI from membrane-based technologies.

Just recently a so called "inspection tracker" was launched by Health Canada. Now, the agency offers an additional database which contains 3,821 inspections (per March 2015) which have been performed since 2012 - many of them outside Canada, e.g. in Europe or Asia. Please read more about the GMP Inspection database.

The implementation of the Guideline ICH Q3D provides a great challenge for both drug manufacturers and active substances producers. Here, you can see the practical advice that the "Industry Coalition" makes available for the Control of Elemental Impurities.

Counterfeit medicines in the legal supply chain are increasingly becoming a problem. Experts are sure that counterfeiters will try more and more to sell fake medicines not only via the Internet, but through "infiltrating" them into the legal supply chain - meaning pharmaceutical wholesalers and pharmacies. Another case became known now. Read more in the news about the counterfeit drugs in the legal supply chain.

A new Strategy Paper has been issued by the European Agencies. Read more about the Network Strategy to 2020.

Data Integrity has become one of the most important GMP compliance issues in the past two years. This has enormous consequences for the concerned companies but also for companies and authorities in EU and US.  Again the US FDA has identified a company that violates regulations and put patients at risk. The company IPCA was already known for not meeting the GMP requirements. Read more about the GMP findings at IPCA and the consequences for companies and authorities dealing with Indian partners.

The ZLG in Germany has published a new Aide Mémoire recently that provides inspectors with a guideline for the supervision of sterile manufacturers. Read more about the content of this New ZLG- Aide Mémoire for the supervision of sterile manufacturers.

The US FDA published data about Transfusion-Related Acute Lung Injury (TRALI) as a part of Advancing Regulatory Sciences . Read more about  TRALI data between 2007 and 2011.