GMP News

To face the possibility of a Hard Brexit, the MHRA has issued updated guidance proposing some necessary arrangements in regard of Clinical Trials of IMPs.

There are regulations for cleaning validation in the pharmaceutical sector and in the manufacture of active ingredients. But what about the cleaning validation of medical devices?

In its "Medical Device Enforcement and Quality Report", the FDA has published current data on its monitoring activities with regard to medical device manufacturers. Find out what's new.

With the implementation of the ICH Q9 document, risk management has become mandatory in virtually all GMP areas. This also applies to cleaning validation. But what can such a quality risk management approach look like for cleaning validation? The American Society of Testing and Material (ASTM) has recently issued a guideline on a Science-Based and Risk-Based Cleaning Processes Development and Validation. What does the Guide suggest?

In a previous News you could already read about the cleaning issues at a US-American pharmaceutical company. Now, the Warning Letter issued provides much more information - also with regard to process validation.

Data integrity is still topic number 1 for national and international authorities. In 2016, the US-FDA presented a draft guidance on that in form of a questions and answers document. Now, it was finalised on 12 December 2018. Read more about the Guidance for Industry "Data Integrity and Compliance with CGMP".

The European Commission has reviewed their list of questions and answers regarding safety features and issued it as version 12. Find out what changed in the Q&As on safety features.

As a result of repeated deviations in the area of aseptic manufacturing, a Korean manufacturer has received a Warning Letter from the FDA.

The Ph. Eur. Commission decided to restructure Ph. Eur. Section 3 on materials and containers. A new Subsection 3.3. has been added to cover items that are classified as medical devices according to EU legislation. Read more about 3.3. Containers for human blood and blood components, and materials used in their manufacture; transfusion sets and materials used in their manufacture; syringes.

In the course of an inspection conducted in October 2018, the Italian health authority discovered several GMP deviations in the areas of sterile manufacturing, packaging and QC testing at an Italian manufacturer. Read more details about the Non-Compliance Report which can now be found in EMA's inspection database.

The FDA published a new Draft Guidance on Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis. The recommendations contained in this guidance apply to the collection of blood and blood components, except source plasma.