GMP NEWS 2021

Questions & Answers on Good Distribution Practices (GDP) - Part 5

In October 2020, the ECA Academy offered the Live Online Training "The GDP Compliance Manager". During the Q&A sessions, many interesting questions were posed to the speakers' team. The ECA would like to share a selection of these Q&As sorted by topic. Part 5 deals with questions related to deviations.

More

Will Cannabis for Recreational Purposes be available in German Pharmacies?

According to the German Liberal Democrats (FDP), adults in Germany should be able to purchase cannabis for recreational purposes at pharmacies and specially licensed shops.

More

Will the EU Concept of a Qualified Person spread the World?

PIC/S is planning to adapt EU GMP Annex 16 and has started a consultation/ adoption process.

More

EUDAMED - Current Status of the Database for Medical Devices

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.

More

EU-Switzerland: MRA for Medical Devices no longer valid

Due to the new EU Regulation on Medical Devices (2017/745) and failed negotiations between Switzerland and the EU, the corresponding Mutual Recognition Agreement (MRA) will become obsolete. This has far-reaching consequences.

More

New Version of the Q&As on Safety Features for Track & Trace

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.

More

Ph. Eur. General Notices Chapter - New Structure and Content

The European Pharmacopoeia Commission adopted a revised version of Ph. Eur. chapter 1. General Notices to provide greater clarity for users.

More

Foreign Matter in Herbal Drugs

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).

More

International Inspections: TGA and the Management of GMP Compliance Signals

The Australian Therapeutic Goods Administration (TGA) has published a guidance on the management of so-called GMP compliance signals for domestic and foreign manufacturers of medicinal products and biological products.

More

Herbal Drugs - What is Well-Established Use?

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?

More

US Implementation of ICH Q12

The US FDA recently issued a draft guidance to help manufacturers implement ICH Q12 by explaining how to submit ECs. In addition, the agency provides general guidance about the elements that are considered ECs for the device constituent part of combination products.

More

Copies in the GMP Environment / True Copies

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?

More

The GMP Requirements for Supplier Qualification

Supplier Qualification is more than auditing. Supplier qualification can be seen as a risk assessment tool. But what are the exact requirements?

More

Problems at Emergent BioSolutions Plant even worse

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.

More

Medical Cannabis in Greece

Greece is currently discussing a new bill about medical cannabis products. Its purpose is to allow medical cannabis companies in Greece to produce medical cannabis and export it to Europe.

More

New USP Chapter on Visual Inspection of Parenterals?

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.

More

Unexpected Deviations and the Role of the QP

Did you know that EMA's Questions and Answers Section to Annex 16 further clarifies the role of the QP in the context of handling unexpected deviations?

More

Recall of Product Samples from U.S. Market Due to Improper Storage Temperature Conditions

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).

More

Questions & Answers on Good Distribution Practices (GDP) - Part 4

In October 2020, the ECA Academy offered the Live Online Training "The GDP Compliance Manager". During the Q&A sessions, many interesting questions were posed to the speakers' team. The ECA would like to share a selection of these Q&As sorted by topic. Part 4 deals with questions related to documentation.

More

FIFO, FEFO, LIFO: What is the meaning?

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?

More

GMP Newsletter

Sign up for the free of charge newsletters.

Sign up now!

GMP Conferences by Topics