ISPE’s new Advancing Pharmaceutical Quality (APQ) Guide: Process Performance and Product Quality Monitoring System (PPPQMS) focuses on the key aspects of maintaining and establishing an effective PPPQMS. An effective PPPQMS is crucial to establishing and maintaining a state of control. It enables continual improvement and is key to proactively identifying the need for product quality and...
The Commissioning and Qualification (C&Q) CoP was one of the first Communities of Practices to be established at ISPE. One of its founding members, Steve Wisniewski, Principal Consultant, CAI, said the Communities of Practice was formed in 2004 to identify and promote more efficient approaches that resulted in pharmaceutical facilities being fit for their intended purpose.
As one of the founders of Cheme Engineering, Nik Krpan was instrumental in the start-up of the company. He became president of the company in 2012. Nik says that leading the company through continued growth has been an exciting aspect of his career. “We started with five people and now we have more than sixty. It’s been really rewarding to be part of a creating an environment where people can...
More than 200 people celebrated the 2022 Facility of the Year Award Winners at a reception and banquet Sunday night at the 2022 ISPE Annual Meeting & Expo at the Gaylord Palms in Orlando, Florida.
For nearly a century, production of water for injection (WFI) was universally accepted to be distillation-based. As emphasis on costs and environmental concerns has grown, pharmacopeias around the world have focused on the quality attributes of WFI to allow for consideration of other production technologies.
Combination Products is one of ISPE’s newest Communities of Practice (CoPs). It started as a Special Interest Group to help people in the industry collaborate and learn from each other.
