iSpeak Blog

Women in Pharma® Member Spotlight on Mei Ping Lee, Chair of the ISPE Malaysia Affiliate’s Women in Pharma®

24 October 2024

With over 23 years industrial hands-on experience in establishing and managing quality management systems within the pre-clinical, clinical and pharmaceutical as well as medical device manufacturing industries, Mei Ping Lee, who goes by Mae, is currently the Quality Assurance Manager at Winwa Medical Sendirian Berhad, Malaysia, a pharmaceutical and complementary products manufacturer and...

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Pharma 4.0™ and Annex 1 Implementation: A New Era for Aseptic Manufacturing

23 October 2024

The pharmaceutical industry is in the middle of a transformative shift, driven by the dual forces of Pharma 4.0™ and the updated Annex 1 guidelines. These changes are introducing innovations that not only enhance the quality and safety of sterile manufacturing but also leverage new technologies to optimize efficiency and compliance. The

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ISPE Releases Updated ISPE GAMP® Good Practice Guide on Validation and Compliance of Computerized Good Clinical Practice (GCP) Systems and Data

8 October 2024

The use of digital information in clinical trials has evolved and expanded rapidly in recent years, raising concerns about data integrity, patient safety, and patient privacy, while also prompting new requirements by regulatory bodies. In response, ISPE has released the