Transfer of manufacturing processes and analytical procedures between facilities or laboratories is a necessary part of pharmaceutical development and commercialization. Technology transfers take the outputs of process...
The 2020 ISPE Europe Annual Conference is Europe’s most comprehensive event on the latest innovations in pharmaceutical manufacturing. This year’s programme is packed with 40+ content-rich sessions led by a dynamic line...
How will the new EC GMP Guide Annex 1 impact the future of aseptic processing? What are some of the latest developments in barrier/isolator technology? Jörg Zimmermann, 2020 ISPE Aseptic Conference Chair, Vice President...
Good Practice Guide: HVAC & Process Equipment Air Filters
The ISPE Good Practice Guide: HVAC and Process Equipment Air Filters aims to be a valuable reference on the selection, application, specification, testing, and operation and maintenance of filters in the pharmaceutical industry. This Guide is intended to be used as supplement to the ISPE Good Practice Guide: Heating, Ventilation, and Air Conditioning (HVAC), providing detailed information into the subject of air filters in HVAC and process equipment applications.
The ISPE Good Practice Guide: Asset Management provides practical guidance for establishing an asset management system that enables organizations to realize increased value from their assets, both physical and non-physical. This Guide identifies best practices in strategic asset management as outlined in the ISO 55000 series of standards. An effective asset management system translates the organization’s objectives into asset-related decisions, plans, and activities using a risk-based approach. This Guide provides recommendations, examples, and resources to help organizations in the development or improvement of their asset management system.
Baseline Guide Vol 4: Water & Steam Systems 3rd Edition
The ISPE Baseline Guide® Water and Steam Systems (Third Edition) aims to assist with the design, construction, operation, and lifecycle management of new and existing water and steam systems. It is intended to help meet Good Manufacturing Practices (GMPs) and comply with regulations and related guidance.
The ISPE Baseline® Guide: Commissioning and Qualification (Second Edition) provides practical guidance on the implementation of a science and risk-based approach for the Commissioning and Qualification (C&Q) of pharmaceutical manufacturing facilities, systems, utilities, and equipment to demonstrate that they are suitable for the intended purpose.
We recognize that the ever-changing nature of this novel virus is concerning and is requiring many of us to adjust our standard practices. Still, we want to assure you that ISPE is here to support your knowledge and connectivity needs.
In this issue of Pharmaceutical Engineering®, we address an array of sustainability topics. This article surveys topics that will likely have a significant global impact on the way we conduct our business over the coming...
Whether networking at events or collaborating through our Communities of Practice, the value of an ISPE membership is in the connections made between pharmaceutical industry professionals and Regulators to collaborate on solutions to common goals and challenges.