ISPE Releases ISPE Good Practice Guide: Process Validation
BETHESDA, Md. (PRWEB) March 28, 2019 -- The International Society for Pharmaceutical Engineering (ISPE ) announced the release of their latest guide, ISPE Good Practice Guide: Practical Implementation of the Lifecycle Approach to Process Validation. This guide provides professional insights for fundamental principles, process lifecycle approaches, and changes in validation practices.
“Patient requirements and product attributes represent the initiative of new approaches within process validation and ISPE’s guide supports current developments,” said Robert Beall, PMP, Director, Product Lifecycle Management, ProPharma Group and Guide Co-Lead. “The guide is a technical and scientific advisory resource to help organizations understand process validation through carefully constructed theories to establish defendable processes in addition to offering assistance with global regulatory requirements.”
From this guide, users will learn:
- The different terminology used by regulators and the similarities in underlying fundamental principles
- Practical implementation advice, including how each of the three validation stages may be implemented and how the stages are linked
- About statistical rationale and information that may be applied at different stages of the lifecycle
- How to maintain a state of control throughout the product lifecycle
In addition to this new Good Practice Guide, ISPE offers a variety of resources to further knowledge and education on Process Validation. These include but are not limited to: 2019 ISPE Process Validation Workshop, Process Validation Training Course, Quality Management Systems Training Course, and Process Validation Discussion papers.
The new ISPE Good Practice Guide: Practical Implementation of the Lifecycle Approach to Process Validation is available online at http://www.ISPE.org/Publications/Guidance-Documents.
About ISPE
The International Society for Pharmaceutical Engineering (ISPE) is the world’s largest not-for-profit association serving its members through leading scientific, technical, and regulatory advancement across the entire pharmaceutical lifecycle. The 18,500 members of ISPE are building solutions in the development and manufacture of safe, effective pharmaceutical and biologic medicines, and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters and training center in North Bethesda, Maryland USA, and its operations center in Tampa, Florida USA. Visit http://www.ISPE.org for more information.
For more information, contact:
Maria Robertson
Senior Director, Marketing Communications
International Society for Pharmaceutical Engineering (ISPE)
Tel: +1-301-364-9207
Email: [email protected]
http://www.ISPE.org
Maria Robertson, International Society for Pharmaceutical Engineering (ISPE), http://www.ISPE.org, 301-364-9207, [email protected]
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