End of December the USP published its revised chapter <381> Elastomeric Closures for Injections which became official on January 1, 2018.
The FDA's Office of Pharmaceutical Quality has published a new MAPP document (Manual of Policies and Procedures) on acceptance criteria and specifications for impurities. In provides principles on the determination of specifications and acceptance criteria for non-mutagenic impurities in authorisation applications, based on clinical relevance. Read more about the Office of Pharmaceutical Quality's new FDA document.
Up-to-date monitoring systems produce vast amounts of data, e.g. pressure, humidity and temperature in clean rooms. In pharmaceutical production practice, there are different approaches to handle this electronic data - alarms especially. Not all of them are ideal from a GMP viewpoint.
ICH Q9 is the major guideline providing principles and examples of tools for Quality Risk Management (QRM). But how do competent authorities look at these systems in their GMP inspections?
The final "Detailed Commission guidelines on GMP for IMPs for human use" have been published in Annex 13 of the EU GMP-Guidelines. What has changed in comparison to the previous Annex 13 in regard to complaints and recalls?
In the current EU GMP Annex 1, the monitoring of 0.5 and 5 µm particles in clean rooms is a requirement. It refers to technical document ISO 14644, Part 1 for measurement. However, the limit for 5 µm for class ISO 5 (ISO 4.8) has been removed from this document. That is why there had been great expectations for the revised Annex 1 draft.
The PIC/S draft guideline "Good Practices for Data Management and Integrity" requires every company to have a data governance system in place in addition to their existing QM system. But how can such a system be implemented? Find out more about the requirements and specifications of the PIC/S guideline for the pharmaceutical Data Governance System.
A company in Canada had sourced products from a supplier who was listed on FDA Import Alert. Therefore, the FDA declared an immediate import ban in this company, as well. Find out more about the FDA Warning Letter to Aztex Enterprises.
The European GDP Guideline which has been published in a revised version on 7 March 2013 has caused a lot of discussion since then. Many requirements leave room for interpretation. On the GDP Association Webpage a section has been set up with frequently asked questions (FAQs). Please read more about the new Questions and Answers on GDP
The British Medicines and Healthcare Products Regulatory Agency (MHRA) has published a report summarising GDP inspection deficiency data from its 2016 inspections.