FDA's Guidance on Development and Manufacture of Drug Substances

  • By: Staff Editor
  • Date: May 15, 2017
  • Source:
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FDA's Guidance on Development and Manufacture of Drug Substances

The US FDA, in November 2012, has announced its adoption of the ICH Q11 guideline on the development and manufacture of drug substances. The guidance explains both the traditional and enhanced approaches in developing and understanding the manufacturing process for a drug substance. It also offer details on the information that should be provided in Module 3 of the Common Technical Document (CTD) sections.

The guidance document is applicable only to the manufacturing of drug substance and is not valid to the finished drug products.

Related Training:

ICH Q11 - API Manufacturing

Key Focus Areas

One of the key requirements necessary for the manufacturer of quality drug substances is to develop a validated processes capable of producing repeatable results. Hence, the guidance requires adherence with quality principles such as: drug-substance quality linked to drug product; process-development tools; approaches to development; drug-substance Critical Quality Attributes (CAQs); linking material attributes and process parameters to drug substance CQAs and design space.

Additionally the guidance covers:

  • Description of manufacturing process and process controls
  • Selection of starting materials and source materials
  • Approaches to developing a control strategy
  • General principles for process validation and evaluation including principles specific to biotechnological/biological drug substance
  • Submission of manufacturing process development and related information in CTD format
  • Process of lifecycle management

The guidance further provides some examples to offer better clarity in understanding and complying with the requirements.

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