GMP News

The EDQM published a draft for a new Ph. Eur. general chapter regarding pyrogen inactivation or removal from primary packaging materials and equipment. Read more about depyrogenation of items used in the production of parenteral preparations.

The Warning Letters sent to API manufacturers in the last few months are a source of comprehensive information. A detailed analysis of them unveils interesting facts and trends on GMP violations with regard to the handling of raw data, OOS results and data integrity.

In June you could already read about the Q&As of the European Medicines Agency (EMA) on the use of PDE (HBEL) values in connection with cross contaminations and cleaning validation. The EMA has now published a report which describes how these questions and answers came into being.

The safety features required for the implementation of the Anti-Counterfeit Directive will have to be implemented by the 9th February 2019. The European Commission released version 10 of the questions and answers catalogue on safety features in July 2018. The specific question of bundle packaging has also been addressed. Get more information about bundle packaging in EU's Q&A document on the safety features.

In August, the Association of German Engineers (VDI ="Verein Deutscher Ingenieure") released three interesting VDI guidelines. The topics addressed are tightness of containment systems, identification of critical impurities in the manufacturing process of medical devices as well as requirements on the planning and implementation of central HVAC systems. Find out more about the new VDI guidelines.

The EMA has published the estimated roadmap of important IT projects. This includes, inter alia, the initial application date of the EU portal for clinical studies. The application had originally been scheduled for the second half of 2019. Now, the initial application is supposed to be possible in 2020.

The European GDP Association has published new Question & Answers on Chapter 3 of the EU-GDP Guide (Premises and Equipment).

The UK Government has released advice regarding the consequences of the Brexit on clinical trials.

In April 2018, the CMDh published a document to clarify questions which arose from the original Q&A document dated March 2017 on the implementation of the Falsified Medicines Directive. Read more about the document "CMDh clarifications on questions received on the implementation of the Falsified Medicines Directive".

In a four-page Warning Letter to a contract manufacturer who produces semi-solid OTC products, the FDA criticizes amongst others the missing tests of starting and finished products.

The topic microbiological environmental monitoring was one of the main focuses of an FDA Warning Letter. Read more about the deviations listed in the FDA Warning Letter issued to the Taiwanese company Taiwan Biotech.