GMP News - Quality Assurance

In January you could read about the publication of the revised ICH Q9 guideline. What is new with regard to quality risk management (QRM)?

In the EudraGMDP database, results of European inspectors are published in so-called Non-Compliance Reports. In the period October-November 2022, there were two reports in the area of GMP, both of which were issued due to cross contamination.

Furthermore, the "Falsified Medicine Directive (2011/62/EU)" requires a "Written Confirmation" for the import of active pharmaceutical ingredients (APIs) from third countries. The APIs imported from countries on the so-called "White List" are an exception to this. In future, Canada will also be listed on this "White List".

In December 2020, you could already read about the ICH announcement to revise the ICH Q9 Quality Risk Management Guidelines. The final version has now been published.

There is currently an ongoing discussion about the microbiological quality requirements for medical Cannabis depending on the route of administration. To move forward authors from the FDA recently published an article about a microbiological study of bulk Cannabis.

In October 2022, the Center for Devices and Radiological Health (CDRH) published a list of new guidances planned for fiscal year 2023 (1 October 2022 - 30 September 2023), as well as older guidances to be reviewed for topicality. What is planned?

The Q&A document "Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products", which was jointly prepared by the EMA and the CMDh, has been updated and the latest version published on the EMA website.