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ISPE: International Society for Pharmaceutical Engineering

Who They Are & What They Create

The International Society for Pharmaceutical Engineering (ISPE) is a non-profit organization that develops standards and provides educational resources for the pharmaceutical and biopharmaceutical industries. ISPE’s guides and standards, particularly their Good Automated Manufacturing Practice (GAMP) series, are widely adopted as best practices for a wide range of processes, from facility design to quality control and validation.

Industries Supported

  • Pharmaceutical Manufacturing
  • Biotechnology
  • Medical Devices
  • Regulatory & Quality Control
  • Engineering & Facility Design

Detailed History

ISPE was founded in 1980 by a group of pharmaceutical engineers. The organization was created to provide a forum for professionals to share knowledge and best practices in an industry that was becoming increasingly regulated. ISPE’s focus on operational excellence, quality, and compliance has made its guides an essential resource for companies and regulators alike. The GAMP 5 guide for computerized systems is a prime example of their influence in establishing industry-wide benchmarks for validation.

 

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