The event opened with the announcement of the preliminary results of the updated survey on the implementation status of the EU Guidelines for Good Manufacturing Practice: Annex 1 – Manufacture of Sterile Medicinal Products.
WASHINGTON, Oct. 8, 2024 /PRNewswire-PRWeb/ -- The Parenteral Drug Association (PDA) 2024 PDA Microbiology Conference, October 7-9, is underway at the Grand Hyatt in Washington, D.C.
This industry-leading event is bringing together industry experts, regulatory officials, and academic leaders to discuss the latest advancements in microbiology as they pertain to the pharmaceutical and biopharmaceutical sectors. Bridging science and compliance is the throughline of the conference.
The event opened with the announcement of the preliminary results of the updated survey on the implementation status of the EU Guidelines for Good Manufacturing Practice: Annex 1 – Manufacture of Sterile Medicinal Products.
In the PDA survey conducted after the anniversary of Annex 1's effective date, more than half (57%) reported 75%-99% compliance while only one-in-five (19%) reported 100% compliance. The least compliant areas identified in the survey were the Contamination Control Strategy, Barrier Technologies, and Premises/Facility. Full study results will be available after the conclusion of the Annex 1 workshop.
To continue to support industry on this topic, PDA is hosting an EU GMP Annex 1 compliance workshop convening regulatory authorities and industry leaders on November 5-6 in Dublin, Ireland as part of its ongoing initiative to provide current knowledge and strategies to pharma professionals to ensure patient health and safety. Founder and CEO, TM Pharma Group, Tracy Chapman emphasized that this workshop will "unlock the secrets to achieving sustained EU GMP Annex 1 compliance by providing insights from regulatory authorities and industry leaders at the PDA Annex 1 workshop". Senior Consultant-Microbiology, ValSource Inc., Frederic Ayers said this "workshop is a must-attend for anyone who wants to understand how the contamination control strategy is critical to Annex 1 implementation."
This year's Pharmaceutical Microbiology Conference also explores a range of microbiology topics, including a NASA presentation on the parallels between microbial contamination control in water systems on the international space station and those in pharmaceutical manufacturing facilities. Both situations face significant challenges in ensuring the production of high-quality water by employing advanced monitoring and sterilization techniques. Sharing insights and innovations from each will help enable the future success of space missions and the integrity of pharmaceutical products. The conference also covers emerging technologies and innovative solutions on the future of microbiome applications—from fecal transplants to living biotherapeutics—as well as the alignment of manufacturing practices with regulatory expectations around microbial contamination to produce life-saving medicines safely and reliably.
About PDA – Connecting People, Science and Regulation®
The Parenteral Drug Association (PDA) is the leading global provider of science, technology and regulatory information and education for the pharmaceutical and biopharmaceutical community. Founded in 1946 as a nonprofit organization, PDA is committed to developing scientifically sound, practical technical information and resources to advance science and regulation through the expertise of its almost 10,000 members worldwide. Go to https://www.pda.org/about-pda to learn more.
Media Contact
Walter Morris, PDA, Inc., 1 3016565900, [email protected], www.pda.org
Yuvi Singh, PDA, Inc., 1 301-656-5900, [email protected], www.pda.org
SOURCE PDA, Inc.
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