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