GMP NEWS 2017

EMA's "Reflection Paper" from May 2016 on dissolution testing for immediate release of oral dosage forms deals with the specific requirements concerning the tests which should be taken into consideration when submitting applications for a marketing authorisation. Get the details about EMA's Reflection Paper on dissolution specification.

During the inspection of an Indian API facility, FDA investigators found that basic requirements for GMP-compliant manufacturing weren't complied with. This led to a Warning Letter. Read more about the detailed deficiencies in cleaning and validation of test methods, and the maintenance of analytical devices.

A draft for Ph. Eur general chapter 3.2.3. Sterile plastic containers for human blood and blood components has recently been published for comments in Pharmeuropa. It is proposed to delete the abnormal toxicity test (2.6.9) (ATT) from the Tests section.

What do storage requirements like, for example "ambient", "room temperature" and "cold chain" exactly mean? Worldwide, there are different definitions for these storage requirements.

In the draft revision of Annex 15 of the EU GMP Guide (Validation / Qualification) there were significant changes in the chapter on cleaning validation threshold determination. Which of these changes will still to be found in the final document? Read on here.

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 has released version 5 of its Questions and Answers on safety features and the German initiative securPharm has just published the Status Report for 2017. Read more about the SecurPharm Status Report 2017 and about the EU's Q&A document on safety features.

Certificates of Analysis (CoA) have to be issued for excipients, APIs, packaging materials and finished products. Regarding those certificates, there are a number of guidelines. A closer look at these guidelines shows that there are several regulatory requirements which are often unknown. Read more about GMP/FDA compliant Certificates of Analysis (CoA).

The European Pharmacopoeia's revised monograph 169 on water for injection (WFI) will become effective by the 1st of April 2017. For the first time in Europe, a monograph will allow the production of WFI with other methods than distillation. But there are still unanswered questions, e.g. how to deal with HPW systems which have been already producing water with WFI quality. Read more about the revision of the Monograph on WFI.

The Drug Commission of German Pharmacists (AMK - Arzneimittelkommission) regularly informs about batch recalls - e.g. due to quality defects. Now, there have been more and more reports about batch recalls due to counterfeit medicines. According to a report of the German newspaper "Deutsche Apotheker Zeitung" edition 5/2017, the company axicorp Pharma is facing such a counterfeits case. Read more about it here.