GMP News

The US FDA recently published a discussion paper addressing artificial intelligence in the manufacturing of medicinal products. The FDA is considering the extent to which its risk-based regulation is applicable to AI technologies in the manufacturing of medicinal products.

Just recently, you could read about the Good Manufacturing and Distribution Practice Symposia 2023, organized by the Medicines and Healthcare products Regulatory Agency (MHRA) on 21 and 22 February 2023. A summary of the GDP part was now published on the MHRA Inspectorate blog.

More than 60 participants attended the ECA Webinar "GDP Update 2023" in March. Many interesting aspects were discussed in the Q&A session. In total, about 20 questions were addressed to the speaker, Dr. Christian Grote-Westrick, which he answered in writing afterwards. We have compiled a selection of the questions and answers for you. You can read Part 2 here.

In the Pharmacopeial Forum, PF 49(3), a proposal of a revised USP General Chapter <711> Dissolution has been published for comments. The background to the publication is the efforts of international harmonization of monographs and general analytical methods of the European, Japanese, and United States pharmacopeias. The new draft represents the Pharmacopeial Discussion Group (PDG) harmonized document.

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.

EMA has published a new version of the "3-year work plan for the Quality domain". This also includes partly renewed timeframes for the revision of GMP specifications.

The USP published the draft monograph for Dronabinol Capsules in PF 49.3. Comments can be sent to the USP until end of July.

In February and April 2023, the "IRIS guide to registration and RPIs" was updated again and is now valid as version 2.13. Like the "IRIS guide for applicants" and "IRIS guide to parallel distribution applicants", the latest versions of this document are available on the EMA website.

The CMDh (Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human) updated the Q&A document on "Renewals" in March 2023 and published it on the HMA (Heads of Medicines Agencies) website in the CMDh - Questions & Answers section in April.

In the Pharmacopeial Forum, PF 49(3), a proposal of a slightly revised USP General Chapter <781> Optical Rotation has been published for comments.

The U.S. Food and Drug Administration (FDA) has recently published a new Warning Letter. An OTC manufacturer received information indicating that the finished drug products produced with isobutane propellants were contaminated with benzene. The company's own analyses as well as results of the FDA laboratory testing confirmed the presence of this impurity. The company failed to perform adequate investigations and so far, the root cause of the benzene contamination is not understood.

Pharmaceutical water systems (PW and WFI) require a ventilating filter on the storage tank. It prevents dirty ambient air from being sucked into the system when water is withdrawn from the tank. This is often referred to as a sterile filter. However, there are numerous requirements for "real" sterile filtration according to the current EU GMP Annex 1. But is sterile filtration even necessary for this application?