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Who we are

ISPE is committed to the advancement of the educational and technical efficiency of its members through forums for the exchange of ideas and practical experience.

ISPE returns to China for the first time since 2017 as ISPE Shanghai. ISPE was founded in 1980 by a handful of people who believed the pharmaceutical industry needed an organization that would deal with practical applications of science and technology for technical professionals. The much-needed forum provided by ISPE began with a Membership of engineers in North America. In time, ISPE Membership expanded beyond engineering to include a broad representation from pharmaceutical professionals.

We lead and facilitate the development of next generation process technologies and innovative technical solutions. On matters of regulation, our focus is on those requirements that impact — or will impact — the licensing of facilities, manufacturing processes and operations, and the sustainability of the supply chain over the product lifecycle. ISPE provides a neutral environment where our individual Members and experts belonging to Regulatory Authorities can engage in open dialogue on issues that will ultimately benefit patients around the world.

ISPE provides support for the Global Pharmaceutical Manufacturing Leadership Forum (GPMLF).

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Guidance Documents

GAMP 5 Guide: Compliant GxP Computerized Systems
  • February 2008
Ten years after its publication, the ISPE GAMP® 5 Guide: A Risk-Based Approach to Compliant GxP Computerized Systems is regarded as the definitive industry guidance on GxP computerized system compliance and validation for companies and suppliers and is referenced by regulators worldwide.
GAMP Good Practice Guide: Manufacturing Execution Systems
  • February 2020
The ISPE GAMP® Good Practice Guide: Manufacturing Execution Systems - A Strategic and Program Management Approach uses a complete lifecycle approach to the development and use of MES for regulated manufacturing as a collection or domain of manufacturing related functions that integrates business and process controls, information flow, and human interaction to facilitate the operation of an organization.
GAMP Good Practice Guide: Enabling Innovation
  • September 2021
The drive within life sciences to improve patient safety and product quality, and provide value to society, while reducing costs requires constant and effective innovation. However, because the pharmaceutical industry operates in a highly regulated sector, some practitioners may apply unthinking, prescriptive, and rigid approaches that are not commensurate to the needs of the process, the nature of the system, and the real risk to the product and the patient.
Cleaning Validation Lifecycle – Applications, Methods and Controls
  • August 2020
Regulatory agencies expect the development and validation of a compliant cleaning program. This critical activity ensures that the risks of contamination, product carryover, and cross contamination are controlled, minimized, and monitored to safeguard patient safety and product quality.
Good Practice Guide: Process Validation
  • March 2019
Guide contributor (co-lead) Robert Beall, PMP, ProPharma Group, shares why process validation is an essential part of the pharma industry and how you’ll benefit from the ISPE Good Practice Guide: Practical Implementation of the Lifecycle Approach to Process Validation.
Good Practice Guide: Technology Transfer
  • December 2018
Transfer of manufacturing processes and analytical procedures between facilities or laboratories is a necessary part of pharmaceutical development and commercialization. Technology transfers take the outputs of process or method development activities and transfer the knowledge to a different location where a process or analytical procedure will be operated.

Not A Member Yet?

Whether networking at events or collaborating through our Communities of Practice, the value of an ISPE membership is in the connections made between pharmaceutical industry professionals and Regulators to collaborate on solutions to common goals and challenges.

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