ISPE Good Practice Guide: Operations Management

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Operations Management Guide Cover

Published: April 2016
Pages: 166

Table of Contents ( 621 KB)

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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:

  • Supply Chain Strategy and Management
  • Manufacturing Operations Strategy and Management
  • Key Performance Indicators
  • Continual Improvement and Innovation
  • Methods and Tools for Continual Improvement

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:

  • Provide reference, guidance, and support to pharmaceutical operations managers in selecting the most appropriate solutions for the identification and completion of the objectives of their manufacturing operations within the framework of their company organization, including external stakeholders and regulatory bodies.
  • Provide operations management with a robust basis for understanding how compliance and continual improvement/innovation can be achieved simultaneously.
  • Define a common language and provide guidance for performance measurement, benchmarking, and improvement.
  • Identify new performance improvement tools, clarifying what is applicable and what is not, for pharmaceutical operations.

This Guide is intended to assist pharmaceutical professionals and others wanting to obtain a detailed understanding of operations management in the functions of:

  • Production
  • Quality
  • Engineering
  • Sourcing and Procurement
  • Logistics
  • Finance
  • Regulatory

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