To face the possibility of a Hard Brexit, the British MHRA has issued an updated guidance proposing some necessary arrangements.
EMA has published a strategic reflection paper "EMA Regulatory Science to 2025". As a consequence, the regulatory landscape, including GMP requirements and standards, needs to be adapted.
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.
The Association of German Engineers (VDI ="Verein Deutscher Ingenieure") has recently released two new draft guidelines from the area of clean room technology: one regarding central air handling systems, and the other one regarding air filter systems.
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 In 2016, the US-FDA presented a draft guidance on that in form of a questions and answers document.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.
The European Pharmacopoeia (Ph. Eur.) Commission adopted 16 new texts including the general chapter on PAT - Process analytical technology (5.25).
In a current Warning Letter from November 2018, the FDA criticised insufficient cleaning validation and verification at a pharmaceutical manufacturer. They referred to 21 CFR 211.67 (a). What was the reason for this?
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.