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Guidance for Industry PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance



Published on CMKC


This guidance is intended to describe a regulatory framework (Process Analytical Technology, PAT) that will encourage the voluntary development and implementation of innovative pharmaceutical development, manufacturing, and quality assurance. Working with existing regulations, the Agency has developed an innovative approach for helping the pharmaceutical industry address anticipated technical and regulatory issues and questions. This guidance is written for a broad industry audience in different organizational units and scientific disciplines. To a large extent, the guidance discusses principles with the goal of highlighting opportunities and developing regulatory processes that encourage innovation. In this regard, it is not a typical Agency guidance. FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.


FDA. 2004, 1-16

Type of publication



  • U.S. Department of Health and Human Services
  • Center for Drug Evaluation and Research (CDER)

Article Classification


Classification Areas

  • PAT
  • Regulatory