Published: April 2016
For the purposes of this Guide, operations are defined as the transformative process within a series of activities, along a value chain extending from supplier to customer. Operations Management designs, operates, and improves supply chain systems for getting work done. The ISPE Good Practice Guide: Operations Management aims to provide the pharmaceutical industry with a knowledge base to promote the use of best practices and operational excellence within pharmaceutical operations management.
The Guide addresses all operations along the supply chain, from the selection of raw materials through to the distribution of final product. Topics considered by this Guide include:
The Guide addresses how specialty, bulk Active Pharmaceutical Ingredient (API), and drug product manufacturing systems are organized and operated in order to guarantee the production, storage, and distribution of products while ensuring drug product quality throughout the supply chain.
This ISPE Good Practice Guide: Operations Management is intended to provide a framework for the management of pharmaceutical operations. It aims to identify and develop industry good practices to:
This Guide is intended to assist pharmaceutical professionals and others wanting to obtain a detailed understanding of operations management in the functions of: