On behalf of the event programme committee and the ISPE International Board of Directors, we want to thank our attendees for participating in this event and supporting continuous innovation and improvement within the pharmaceutical industry!
Daniel Boergel, Director Microbiology & Aseptic Technique | Quality Management Generics, Fresenius Kabi Deutschland GmbH highlighted key updates during his session "New Annex 1 Challenges for LVP Bag Manufacturing" at the 2022 ISPE Pharma 4.0™ and Annex 1 Conference.
In the new Annex 1, SVP bags are added to the list of “containers closed by fusion” that will require 100 % container closure integrity testing (CCIT) as final product control. Implementing a 100 % CCIT technology for filled flexible containers presents unique technical challenges and is contrary to the recent year's industry development toward process analytical technology (PAT)
With the Annex 1 implementation period being one year, what are the next steps if the current technology doesn't exist today? Daniel Boergel, Director Microbiology & Aseptic Technique | Quality Management Generics, Fresenius Kabi Deutschland GmbH addressed this question during his session "New Annex 1 Challenges for LVP Bag Manufacturing" at the 2022 ISPE Pharma 4.0™ and Annex 1 Conference.
Regulation has a powerful impact on innovation: it can stimulate ideas and block their implementation. Given this, how much do regulators understand and support Pharma 4.0 initiatives, and how will they regulate this area in the future?
During the 2022 ISPE Pharma 4.0™ and Annex 1 Conference session "Regulatory View on the Holistic Control Strategy and Digital Maturity," Mark Birse President, Technical, Parexel, explored the role regulators can play in advancing innovation.
Annex 1 of the EC GMP Guide "Manufacture of Sterile Medicinal Products" has a long history. First published in 1989, there have been a total of 5 adaptations in 1996, 2003, 2005, 2007 and 2009, but no complete revision. In 2012, there was a proposal for a complete revision which resulted in a concept paper in 2015. The first draft for comments from industry stakeholders was...
The 2022 ISPE Pharma 4.0™ and Annex 1 Conference takes place in Vienna, Austria and virtually on 7-8 December, and will offer attendees several unique perspectives, case studies and site tours. This...
