At the May 2024 PDA Good Aseptic Manufacturing Conference, Austrian (AGES) GMP inspector Christina Meissner reviewed the shortfalls that inspections are revealing with Annex 1 implementation since it came into force in August 2023. Our feature story provides a lot of valuable insights from Meissner on the do’s and don’ts of applying quality risk management, deploying contamination control strategies, transferring materials, and process retrofitting and the deployment of emerging aseptic technologies.
Along with a feature story on a presentation given at a recently held conference by a leading regulator that addresses the challenges and developments in a key area of concern, our Weekly Supplements include a summary listing of the “Updates in Brief,” drug GMP warning letters and recalls, and EMA non-compliance reports that have been posted on IPQ’s website during the week. Subscribers can then click through to the full posting.
Also provided, where applicable, are links to the parts of in-depth stories and Monthly Updates that have been released during the week.
Appended to the issue is a chronological listing of the headlines of the in-depth stories that IPQ has released since 2020. Readers of the Weekly Supplement are invited to click through to those that are of particular relevance to the regulatory presentation, news briefs, or compliance developments provided in the issue. Those of especially high relevance to the featured regulator story are indicated with a red star.
