cGMP Guidance: Sterile Drug Products Produced by Aseptic Processing

  • By: Staff Editor
  • Date: November 30, 2016
  • Source:
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cGMP Guidance: Sterile Drug Products Produced by Aseptic Processing

This guidance is proposed to aid manufacturers of sterile drug and biological products meet the FDA cGMP requirements when manufacturing these products under aseptic processing. This guidance replaces the 1987 Industry Guideline on Sterile Drug Products Produced by Aseptic Processing.

For sterile drug products that are subjected to a new or abbreviated drug application (NDA or ANDA) or a biologic license application (BLA), this guidance document should be used in conjunction with the guidance entitled Guideline for the Submission of Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products.

This guidance document does not address all aspects of aseptic processing. Although it explains CGMP issues relating to the sterilization of components, containers, and closures, terminal sterilization of drug products is not discussed.

Summary of Requirements

The Guidance details the requirements for:

  • Building and Facilities: This includes requirements for critical areas-Class 100, supporting clean areas, clean area separation, air filtration and design of the aseptic area
  • Personnel training, qualification and monitoring
  • Preparation and inspection of containers/closures
  • Establishing endotoxin control
  • Time limitation for each phase of the aseptic processing
  • Validation of aseptic processing and sterilization
  • Laboratory controls including environmental monitoring, microbiological media and identification, prefiltration bioburden, alternate microbiological test methods and practical monitoring.
  • Sterility testing including microbiological controls, sampling and incubation, and investigation of sterility positives
  • Review of all the batch records and process control documentation

Related Training:

Guideline to Aseptic Technique and Clean Room Behavior

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