GMP NEWS 2018

A new draft EMA Guideline requires that GDP-Guidelines for medicinal products should be taken into consideration for IMP shipments.

There isn't much time left until the safety features required in the future will have to be implemented in order to comply with the Falsified Medicines Directive which will enter into force on 9 February, 2019. The German initiative securPharm has published a status report in this issue for the year 2018. Read more about the "securPharm Status report 2018".

If a company neglects basic GMP principles, it is not very likely for it to pass an FDA inspection. Read here, what violations concerning the testing of incoming materials, the final testing of finished products and the control of production processes lead to a warning letter.

A new PIC/S Guidance can help Competent Authorities (CA) prioritising resources for GMP inspections. It also serves as a model for the pharmaceutical industry for their risk based supplier qualification activities.

In April 2018, the EMA published the final version of the Q&A document on the use of Health-Based Exposure Limits (HBELs) without special notice. The draft version had become necessary in 2016 because the EMA had generated widespread uncertainty within the pharmaceutical industry with their guideline on setting these limits (PDE values as well). Find out more about the EMA HBEL Document.

The USP published a draft of a new general chapter on the Application of Moisture Vapor Transmission Rates for Solid Oral Dosage Forms in Plastic Packaging Systems. Additionally the general chapter Containers—Performance Testing <671> has been revised and published for comment in the same issue of PF.

The FDA recently published its final guidance on liposomes. Read more about the authority's guidance for industry on Liposome Drug Products.

Together with project partners from industry and research & development, five associations have agreed on a testing method for evaluation of migration from paper and paperboard. Read more about the migration standard.

Due to severe GMP violations, the US FDA has issued a warning letter after inspecting a Mexican pharmaceutical manufacturer. Major deficiencies have been found in the pharmaceutical water system as well as in microbial laboratory testing.