How to Comply with FDA cGMP Requirements for Phase 1 Investigational Drugs?

  • By: Staff Editor
  • Date: February 20, 2017
  • Source:
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How to Comply with FDA cGMP Requirements for Phase 1 Investigational Drugs?

The phase I of a clinical trial involves the initial introduction of the investigational new drug (IND) into the human beings. Consequently, it is important to regulate these studies to ensure patient safety. The FDA guidance outlines the current good manufacturing practices (cGMP) for most of the investigational drugs used in phase 1 clinical trials.


Almost all of the investigational new drug and biological products including placebos that are used during the phase I of human clinical trials are covered under this guidance. The guidance applies to phase 1 drugs including investigational recombinant and non-recombinant therapeutic products, vaccine and allergenic products, in vivo diagnostics, plasma derivative products, blood and blood components, gene therapy and somatic cellular therapy products.

However, the guidance does not cover the following phase 1 investigational products:

  • Human cell or tissue products controlled uniquely under § 361 of the Public Health Service Act.
  • Clinical trials for products that are subjected to the device approval or clearance provisions of the FD&C Act.
  • Already approved products that are used during phase 1 of human clinical trials e.g., for a new indication.
  • Positron Emission Topography (PET) drugs subjected to § 501(a)(2)(C) of the FD&C Act and new PET cGMP in 21 CFR part 212 when finalized.

Related Training:

FDA's GMP Expectations for Phase I and First-in-Man Clinical Trials

Guidance for Industry: CGMP for Phase I Investigational Drugs

Summary of Requirements

The cGMP guidance details the requirements for:

  • Personnel education, experience, and training.
  • Roles and responsibilities for quality control (QC) function.
  • Facilities and equipment’s used for manufacturing phase 1 investigational drug.
  • Control of components, and containers and closures.
  • Maintaining records for manufacturing and process control procedures.
  • Laboratory controls.
  • Packaging, labeling and distributing investigational Phase I drugs.

The guidance further addresses the recommendations for special manufacturing products including biotechnology and sterile products to ensure clarity in adhering to the FDA cGMP requirements.

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