GMP NEWS 2019

A revised version of the Ph. Eur. Monograph Semi-solid preparations for cutaneous application has been published in Pharmeuropa.

The GMP regulations contain many indefinite legal terms. Procedures and processes should be appropriate, regularly repeated, or sufficient. Now, the question is how to concretise appropriate, regularly repeat and sufficient?

With the coming into force of the Advanced Therapy Medicinal Products (ATMPs) GMP rules as Part IV of the EU GMP Guidelines, a new chapter has been opened on the manufacture and quality control of ATMPs. Special requirements are placed on the QP when an ATMP is combined with a medical device.

Following incidents involving the transmission of multi-resistant germs during the use of faecel microorganisms for transplantation, the FDA has established additional measures to minimise the risk of transmission.

The 10th edition of the Ph. Eur. will be released in July 2019. The new and revised texts will become official on 1 January 2020.

The data integrity topic raises a number of questions. Current questions are addressed in a loose sequence of News. Question 4: Does the deletion of data have to be regulated in a SOP?

The US FDA has recently published a Warning Letter describing the deficiencies observed during an inspection performed in September 2018 at a US pharmaceutical manufacturer. One serious deficiency concerns leaking product containers. Furthermore, defects in the stability programme, in the CAPA system and in data integrity have also been reported.

The ICH E8(R1) draft Guideline on General Considerations for Clinical Trials reached Step 2b of the ICH Process in May 2019 and has entered the public consultation period.

The previous draft chapters were canceled. Therefore, USP´s General Chapters–Packaging and Distribution Expert Committee has published new proposals on elastomeric components.