The 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:
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The "ISPE GAMP® Good Practice Guide: Enabling Innovation – Critical Thinking, Agile, IT Service Management" discusses how critical thinking based on product and process knowledge and quality risk management can enable...
iSpeak Blog

Competitive advantage and sustained business results depend on leaders building and maintaining a strong culture. This has been reinforced by the increased challenges in attracting and retaining talent. The FDA is also placing significant focus on Quality Management Maturity. But how do leaders know if they are on track? Assessing leadership systems is often overlooked or much more difficult...

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As we approach the end of this year, we want to thank each of you–members, volunteers, leaders, and staff. Through all the challenges faced this year, we appreciate your patients, great work, commitment, and dedication...
iSpeak Blog

Vaccine Manufacturing

The industry is experiencing an acceleration in the development and approval of novel prophylactic and therapeutic vaccine modalities. Concurrently, many biopharmaceuticals are experiencing the benefits of manufacturing process intensification (PI). Describing such advances for cell-culture based processes is challenging in the field of vaccinology because of...

News & Press Releases
09 December 2021
ISPE announced the release of the ISPE Guide: Advanced Therapy Medicinal Products (ATMPs) – Autologous Cell Therapy , a first-of-its-kind guide about the development and design of manufacturing facilities for ATMPs. ATMP therapies include cells...
20 January 2022 - 20 January 2022
The Commissioning & Qualification and Validation (C&Q&V) BeNeLux Community of Practice (COP) will be a new COP linked to the Belgium and Netherlands affiliate of the ISPE. The COP will consist of a Steering Committee (SC) and members. The...
iSpeak Blog

It is a great honour and pleasure for me as Chair of the ISPE Board of Directors and Chair of the 2022 ISPE Aseptic Conference Program Committee to give you an overview of the upcoming conference including information about the knowledge that will be shared, a look at some of the speakers, and details about a few of the networking opportunities.

17 August 2022 - 19 August 2022
>>> ADD TO CALENDAR Visit Our Event Website Conference Tracks include: ✔ Regulatory, Quality & Compliance ✔ Pharma 4.0 & Digitization ✔ Continuous Processing ✔ Sterile & Aseptic Operations ✔ Contamination Control, CQV ✔ Single Use Technologies ✔...
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