Updated Guide to Microbiological Control for Non-Sterile Pharmaceuticals – 2023


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This Guide is relevant to non-sterile pharmaceutical, cosmetic and toiletry manufacturing industries. There have been significant changes in the microbiological regulations, controls, and testing of non- sterile products. Much of the changes has been prompted by the many recalls of non-sterile products worldwide.

This publication has been updated with the current best practices, regulatory updates and references and covers:

  • Microbiological testing and data handling
  • Facility and equipment design
  • Objectionable microorganisms
  • Cleaning & disinfection
  • Risk assessment & data management
  • Environmental monitoring
  • Regulatory expectations for non-sterile manufacture

This publication is a practical guide for experienced and non-experienced Microbiologists, Quality Assurance Personnel and Qualified Persons.