GMP NEWS 2021

The European Commission published Questions & Answers on 26 May 2021, the day of application of Regulation 2017/745 for medical devices. The Questions & Answers are related to the requirements and tools for the safety of medical devices, including EUDAMED.

The European Commission has published Version 18b of the "Questions & Answers" on safety features. In particular the update took into account the new ISO standard for Packaging Tamper verification features.

A revised version of Ph. Eur. Chapter 2.8.2 Foreign Matter is available. It clarifies the requirements for other foreign matter like moulds and animal contamination and any other unwanted matter (e.g. glass, metal, plastic).

Herbal medicinal products can be registered via the well established use approach within the EU. But what is needed for the simplified registration and how to demonstrate well established use?

In the context of data integrity, copies and how to deal with them play a central role. How are copies defined, what do the regulations require and what does an inspector expect?

You can't actually believe what you read in the Form 483 that the FDA issued to the Emergent BioSolutions site in Baltimore - the site that suffered a mix-up in the manufacture of a Covid-19 vaccine.

In the current Pharmaceutical Forum PF 47(3), a Stimuli article describes the weaknesses in the current specifications for testing parenterals for particles and how these could be addressed in a new USP chapter.

A global healthcare company is voluntarily recalling 1,468 product samples from the U.S. market because they were stored at temperatures below storage requirements. The products affected are used to lower blood glucose levels in people with diabetes. The recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).

FIFO, FEFO and LIFO are the three main strategies for warehouse management. But what do the three abbreviations actually stand for and what exactly do they mean?