Germany/Austria/Switzerland Affiliate
Germany/Austria/Switzerland Affiliate
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Global News
|VideoThe 2022 ISPE Biotechnology Conference will focus on themes to level up agility in the new normal. Register now today to learn what’s in store for the future of biopharmaceutical manufacturing, examining how companies...
|26 May, 2022iSpeak BlogA panel discussion held on 26 April during the 2022 ISPE Europe Annual Conference focused on Sustainability, Annex 1 Revision Implementation, and Good Engineering Practice and...
|25 May, 2022iSpeak BlogA panel discussion held on 27 April 2022 during the 2022 ISPE Europe Annual Conference focused on Digital Transformation. -
Global Events
GAMP® Data Integrity 21 CFR Part 11 Training Course
This GAMP Data Integrity 21 CFR Part 11 Training Course will cover data integrity, electronic records and signatures, and the compliant operation of GxP Computerized Systems...Pharma Facilities Project Management Training Course
Specifically targeted to the needs of facility projects within the regulated pharmaceutical industry and demonstrates the value inherent in the use of “good practice” project...Biopharmaceuticals: CMC Aspects
Biopharmaceuticals: CMC Aspects Training Course (T67) New Course! Overview This new instructor led course is an advanced level course on Chemistry, Manufacturing and Controls... -
Videos
|VideoThe 2022 ISPE Biotechnology Conference will focus on themes to level up agility in the new normal. Register now today to learn what’s in store for the future of biopharmaceutical manufacturing, examining how companies...
|VideoRegister for the ISPE Expert Xchange: Regulatory Summit on ICH Q9 Revision on 9 June from 1000–1330 ET to learn from and collaborate with global regulators—including members of the ICH Q9(R1) Expert Working Group. Get a...
|VideoThe past two years have seen unprecedented innovations in the development and manufacturing of pharmaceuticals. Sessions, panel discussions, and workshops at the 2022 ISPE Annual Meeting & Expo will provide you with...
Guidance Documents
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Good Practice Guide: Membrane-Based WFI Systems
Good Practice Guide: Membrane-Based WFI Systems
PublishedThe ISPE Good Practice Guide: Membrane-Based Water for Injection Systems provides expert guidance on the design, operation, maintenance, and quality aspects of membrane-based WFI systems, including generation, storage, and distribution. This Guide reflects an industry wide collaborative effort by a diverse range of industry experts that include equipment providers, engineering firms, consultants, and pharmaceutical manufacturers. The information presented in this guide is the combination of proven technological solutions, microbial control methods, process analytical technology, and operations and maintenance practices. -
Good Practice Guide: Continuous Manufacturing of Oral Solid Dosage Forms
Good Practice Guide: Continuous Manufacturing of Oral Solid Dosage Forms
PublishedThis Guide reviews the unit operations typically employed in continuous manufacturing and aims to establish a set of minimum equipment requirements for each system to function as part of an integrated process train. While most of the units are well-understood and used in batch manufacturing, the Guide considers the changes in physical and automation requirements that will allow each unit to work in concert as part of a successful continuous manufacturing platform. Operations unique to CM, loss-in-weight feeding and continuous blending, are discussed, including how these systems affect upstream and downstream operations. -
APQ Guide: Change Management (CM) System
APQ Guide: Change Management (CM) System
PublishedThe change management system is a fundamental element of the PQS described in ICH Q10. Effective change management enables quality improvement and ensures a continued state of control. The ISPE APQ Guide: Change Management System provides a quality management framework for assessing and advancing change management systems. -
Good Practice Guide: Controlled Temperature Chambers 2nd Edition
Good Practice Guide: Controlled Temperature Chambers 2nd Edition
PublishedThe Guide has been revised to align with current industry practice, particularly with respect to the ISPE Baseline® Guide: Commissioning and Qualification (Second Edition), presenting a cost-effective way of demonstrating and maintaining compliance. The most significant changes are:
Realizing the promise of any novel viral vector therapeutic depends on the innovator’s ability to constantly meet evolving program requirements set in the product’s preclinical; clinical; chemistry, manufacturing, and controls (CMC); and market strategies. A...
