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Manufacturing Sterile Products to Meet EU and FDA Guidelines

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Manufacturing Sterile Products
to Meet EU and FDA Guidelines

In drug and device manufacturing, sterile means precisely what it says: The total absence of viable microorganisms. Obviously, not everyone is meeting this standard:
  • A meningitis outbreak kills 64 in 20 states. It is traced back to steroidal injections manufactured by a New England compounding center.
  • A Nevada-based compounder recalls all its sterile compounded products after the FDA issues warning for lack of sterility assurance and general quality control.
  • A China-based contract manufacturer and contract sterilizer, receives a warning letter for shortfalls in sterilization validation.

Poor microbial contamination control is now a top Form 483 observation. The focus to date has been on compounding pharmacies, but no FDA- or EU-regulated manufacturer is exempt from its country’s purity laws.

Now’s the time for a hard look at your manufacturing processes.

This timely new management report from FDAnews spells out how U.S. and EU manufacturers must handle sterile processing, focusing first on the basics:

  • Qualified and well-trained personnel
  • Suitable premises
  • Suitable production equipment
  • Validated methods for all critical manufacturing steps
  • Documentation of environmental conditions and in-process controls

You’ll examine in-depth the two methods to manufacture sterile medicinal products:

  • Terminal sterilization
  • Aseptic processing

Equally important — primary product packaging. This report offers clear guidance to the appropriate package sterilization method for every sterile product you offer.

Here’s just a sampling of specifics covered:

  • FDA and EU regulatory requirements sterile products must meet
  • How to set up workspaces and carry out manufacturing of terminally sterilized products
  • How to set up workspaces and manufacture sterile products under aseptic conditions
  • Cleanliness grades for clean rooms, personnel and materials, and how to achieve them
  • How to design and construct air locks to ensure the quality of clean room conditions
  • How to conduct risk-based validation for all sterile processes to meet GMP requirements
  • Advantages and disadvantages of common filling methods
  • How to prepare, implement, document and report a media fill
  • Measures to take when acceptance criteria are exceeded
  • About the freeze-drying process, including qualification and validation
  • About microbiological monitoring, including methods, equipment and contamination sources
  • And much more

The New England Compounding Center (NECC) has just agreed to a $100 million settlement in the meningitis case. That’s the last thing your company wants to face.

 

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Table of Contents

  • Air Lock Concepts
  • Manufacture of Terminally Sterilized Products
  • Sterilization Processes
  • Aseptic Processing
  • And More …

View the entire TOC

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