GMP News - Quality Assurance

In April 2023, the Questions & Answers documents related to centralised marketing authorisation procedures were revised and published on the European Medicines Agency (EMA) website. The Q&As, which can be used by marketing authorisation holders and applicants of centralised procedures, provide answers to potential questions at different stages of the centralised marketing authorisation application process.

The U.K Medicines and Healthcare products Regulatory Agency MHRA is working on a new international recognition framework, including EMA and FDA.

In March 2023, the ECA offered the Live Online Training "How to register APIs in Brazil". With regard to Brazil's Registration procedures for APIs, a set of the most important questions raised during the training and the respective answers provided by the speakers Ms Marieke van Dalen, Global Regulatory Specialist, Aspen, The Netherlands, and Ms Susan Swiggers, Customer & Regulatory Support Officer, Aspen, The Netherlands, are listed in the following.

If you are a non-EU based company exporting drug products into the EU, it is essential to understand the role of a QP. It's also helpful to understand all other EU-GMP requirements to be better prepared for inspections.

In October 2022 you could already find out in a news that the FDA does not accept the manufacture of medicinal products on equipment that is also used to manufacture non-pharmaceutical products. But what are the consequences if the FDA does discover such manufacturing?

The EMA has published a Guidance for Industry on "Good practices to ensure continuity in the supply of human medicines, prevent shortages and reduce their impact". It provides ten recommendations for various stakeholders.

Due to deficiencies found in an FDA inspection, a US pharmaceutical manufacturer has now received a Warning Letter. Among other things, a dead leg in the pharmaceutical water system is listed as a deficiency.