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TGA has published guidance regarding the interpretation of the PIC/S Guide to GMP for compouned medicines

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TGA has published guidance regarding the interpretation of the PIC/S Guide to GMP for compouned medicines

If you hold a TGA licence to manufacture compounded medicines, you should be reading it to understand what tests are required for your quality control.
 
Some important points that are mentioned are as follows.

  • Environmental Monitoring data must be available
  • For non-sterile products
    • appropriate microbiological testing of starting materials and products should be in place to demonstrate compliance with TGO 77 requirements
  • For sterile products
    • A documented sterility test programme must be in place. This could include sterility testing, endotoxin testing, media fills studies and container closure testing
    • Appropriate disinfectants that shows effectiveness in reducing particulates to an "acceptable" level are to be used in clean areas
    • the identification of all microorganisms in Grade A areas should routinely be to species level
    • Isolates from Grade B should be identified to at least genus level except when:
      • High individual counts are recovered
      • Negative trends indicating a deterioration in environmental control emerge
      • Recovery of potentially objectionable organisms

Click here to read the full guide.
 
Contact us if you require assistance on any of the tests mentioned.