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ISPE, a global not-for-profit association of 25,000 pharmaceutical science and manufacturing professionals, has released its latest industry-impacting Good Practice Guide on Maintenance.
The ISPE Good Practice Guide: Maintenance provides current, established practices to help achieve technical and regulatory accuracy and cost-effective compliance whether in a new maintenance program or reviewing an existing program for effective strategy and efficiency. The Guide is intended to be used as a tool for the development, implementation, and execution of a maintenance program in a manufacturing environment. The guide is focused on maintenance in cGMP areas where maintenance strategies, plans, SOPs, and quality procedures and policy application are developed.
Because the guide was written by a group of maintenance professionals from many pharmaceutical companies from around the world – and reviewed by the U.S. Food and Drug Administration – it is in fact a benchmarking tool. The key concepts in this guide can be used knowing that they have general acceptance in the industry.
“ISPE is always grateful to the many industry leaders who volunteer their time, knowledge and expertise in an effort to bring useful information to their colleagues,” said ISPE president and CEO Robert P. Best. “The release of this latest guide is the culmination of their hard work and commitment to improving the industry.”
As with all ISPE technical documents, the ISPE Good Practice Guide: Maintenance utilizes a practical, pragmatic, non-theoretical approach, giving the reader guidance on solving problems and serving as a valuable tool for addressing regulatory inspections and compliance issues. Of particular interest in the guide is the “Reliability Curve” graphic illustration and the Table of Regulatory Citations. To view more of what is covered in the technical document visit the Table of Contents.
In tandem with the global release of the ISPE Good Practice Guide: Maintenance, is the offering of a live 60-minute Webinar, “Launch of the ISPE Good Practice Guide: Maintenance, “ being held May 19. This Webinar will identify how the new guide can provide solutions for structuring a maintenance program and provide practical tools that will help attendees ensure quality and compliance of maintenance operations. For more information, or to register for this event, please go to www.ispe.org/onlinelearning.
ISPE, the International Society for Pharmaceutical Engineering, is the society of choice for 25,000 pharmaceutical science and manufacturing professionals in 90 countries. ISPE aims to be the catalyst for "Engineering Pharmaceutical Innovation" by providing Members with opportunities to develop technical knowledge, exchange practical experience, and collaborate with global regulatory agencies and industry leaders. Founded in 1980, ISPE has worldwide headquarters in