LOGFILE

Your GMP-Briefing
October 2, 2024
 

LOGFILE Feature: Insights from the PDA/FDA Joint Regulatory Conference 2024
Dear Colleagues,

Reading SOPs is not Training! This powerful statement was echoed in several sessions with the PDA/FDA Joint Regulatory Conference 2024. It highlights a critical point: training is more than just reading procedures – it requires performance evaluation.

Sabine Paris and Thomas Peither attended the event and have highlighted some of the other key takeaways in today’s feature.

The full report will soon be available on our online GMP knowledge portal, the
GMP Compliance Adviser.




MHRA: Guidance for Manufacturers Following Revised Brexit Deal

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued new guidance for wholesalers and manufacturers in response to the Windsor Framework, which updated the terms of Brexit.



Swissmedic: SwissGMDP Database Launched

Swissmedic has launched the SwissGMDP database, which gives public access to GMP and GDP certificates of all authorised Swiss pharmaceutical companies.



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GMP Question of the Week

Where can you find regulatory requirements for isolator technology?



EMA: New Q&As for Co-processed Excipients Used in Solid Oral Dosage Forms

The EMA has published for consultation new Q&As for co-processed excipients (CoPEs) used in solid oral dosage forms. The document outlines the quality requirements for CoPEs used in solid oral dosage forms in both human and veterinary medicinal products.



Anvisa: Dashboard with List of APIs Awaiting Registration

Brasil‘s Anvisa has launched a new tool, a dashboard, which allows you to consult the list of active ingredients in medicinal products for which registration applications are being assessed by the agency.





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