GMP NEWS 2016

Three new chapters of an interpretation of the EU-GDP Guidelines with temperature mapping templates have been published. Please read more about the new Guidance Chapters of the ECA/PQG Working Group.

Various competent authorities are performing inspections. But who is subject to such an inspection?

A draft for a new General Chapter "5.24. Chemical Imaging" has been published for comments in Pharmeuropa 28.2. Deadline for comments is June 30, 2016. Find out more about the proposed new Ph. Eur. general chapter 5.24. Chemical Imaging.

In a recent blog, the U.K. Medicines and  Healthcare Products Regulatory Agency reminds companies to assure their supply chain integrity. To support stakeholders, a three step guidance is given.

Currently, the CBER issued a draft guidance document on the bacterial testing of platelets intended for transfusion. The document is open for comments and should, when finalized, supersede the recommendation in regard to bacterial contamination testing in the document entitled “Guidance for Industry and FDA Review Staff: Collection of Platelets by Automated Methods”. Find out more in the draft "Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion".

Again, the US American FDA has issued a Warning Letter to a manufacturer of sterile medicinal products. Comprehensive and serious violations of GMP principles were observed at the Indian manufacturer Emcure Pharmaceuticals Limited. Part 1 of the News deals with the topic insufficient aseptic practices. Read more about the most significant deviations in the Warning Letter.

The new Annex 16 "Certification by a Qualified Person and Batch Release" will become effective as of 15 April 2016. The contents will reflect the coming state of expectations regarding the batch release.

The distribution channel and the storage of medicinal products have been strictly regulated since the introduction of the new EU Good Distribution Practice Guideline (EU GDP Guideline). Now, a German Court has decided a case in which a medicinal product had seemingly the quality required but had left the legal supply chain temporarily. Read more about the court judgement and the consequences for the GDP environment.

A new chapter of an interpretation of the EU Good Distribution Practice Guide (GDP) has been published jointly by the ECA Foundation Working Group on GDP and the Pharmaceutical Quality Group (PQG). Please read more about the new Chapter 8 of the GDP interpretation.