ISPE has released its Good Practice Guide on Maintenance. It provides current, established practices to help achieve technical and regulatory accuracy and cost-effective compliance. These are useful for a new program or when 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. It is focused on maintenance in current Good Manufacturing Practice (cGMP) areas where strategies, plans, and quality procedures and policy application are developed.
The guide is written by a group of professionals from pharmaceutical companies from around the world and has been reviewed by the US Food and Drug Administration
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