FDA Guidance on cGMP Requirements for Combination Products

  • By: Staff Editor
  • Date: February 02, 2017
  • Source:
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FDA Guidance on cGMP Requirements for Combination Products

The US regulatory pathway for combination products is not always very clear. As combination products include constituents that would normally be regulated under different types of governing authorities, they raise regulatory, policy, and review management challenges.

US FDA has recently issued a final guidance detailing the cGMP requirements for combination products including drug-drug, drug-device, device-biologic or drug-biologic combination products. The guidance follows the 2013 final rule on cGMP requirements for combination products.

Related Training:

Navigating the new FDA World of Combination Products

GMP Requirements for Combination Products for the Medical Products Industry

Combination Drug/Device Products CGMPs - Final Rule

Summary of Requirements

Key topics addressed in the guidance includes:

  • Overview of the 2013 final rule on CGMP requirements that apply to each of the constituent parts of the combination products.
  • Role of the lead centre and other Agency components.
  • Definitions and meaning of various terms related to combination products including manufacture, manufacturer, constituent part and component, device, container, closure and convenience kit.
  • cGMP requirements that apply to a product or a facility.
  • Provisions from the device QS regulations including management responsibility, design controls, purchasing controls and corrective and preventive actions (CAPA).
  • Provisions from the drug cGMPs including:
    • testing and approval or rejection of drug product components, containers, and closures
    • Calculation of yield
    • Tamper-evident packaging requirements for OTC human drug products
    • Expiration dating
    • Testing and release for distribution
    • Stability testing
    • Special testing requirements
    • Reverse Samples
  • Combination products that include biological products and Human Cells, Tissues, and Cellular and Tissue-based Products (HCT/Ps).
  • Application of cGMP requirements to special type of products including prefilled syringe, drug-coated mesh and Drug Eluting Stent (DES).

The guidance document also covers hypothetical scenarios that explain how to comply with certain cGMP requirements for specific types of combination products.

Click here to download the file
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