GMP NEWS 2016

Module V of the Guideline on Good Pharmacovigilance Practice (GVP) has been revised by the European Medicines Agency (EMA). Deadline for Comments is May 31, 2016. Module V covers the topic "Risk Management". Find out more about the revised GVP Module V.

Related to the current issues with the ZIKA virus, the FDA published a new guideline about Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products.

The CAT monthly report of the January meeting 2016 provides you with information about statistical data, classification of ATMP, scientific advice and more on ATMP. Read more about application procedures, guidelines and related documents on advanced therapies.

Since 1st October 2012, special regulations have been applying to the US Type II Drug Master Files. This year in February, the FDA published a new Guidance for Industry. Read here what the DMF holder has to consider when submitting data about the API Drug Master File.

After the revision of the General Chapter on quality testing of sterile medicinal products in the US American Pharmacopoeia had already been announced last year in the USP 38-NF 33, the USP is planning a new revision. Read more about the revision of Chapter <1>.

A Task Force initiated by the ECA Foundation has developed a Guidance document which aims to support Responsible Persons (RPs) for Good Distribution Practice (GDP).  Please read more about the Code of Practice for RPs.

Supplier Qualification is more than auditing. Supplier qualification can be seen as a risk assessment tool. But what are the exact requirements for qualifying suppliers?

The Heparin Scandal has changed the regulation and the enforcement actions against API manufacturers like no other case in the last 20 years. Now, it seems that falsified Heparin was detected again at a manufacturer in China. Read more about the background of the Heparin case and the GMP Non Compliance Report issued in EudraGMDP for Dongying Tiandong Pharmaceutical.

On 2 February 2016, the EMA published the comprehensive minutes of the HMPC Meeting on 23-24 November 2015. Herein, you can find a lot of information about the work of the HMPC in the past year. Read more about the HMPC meeting last November.