must comply. The sterility tests published in editions of the BP and Ph. Eur. prior to 1998 are not acceptable. The TGA guidelines for sterility testing of therapeutic goods provide guidance for sterility testing of sterile therapeutic goods supplied in Australia for human use. These guidelines, however, are not mandatory for industry. Non-sterile products The (Chapter 4F) set out microbial limits which apply to non-sterile dosage forms. All non-sterile dosage should include limits for microbial content in the finished product batch release and expiry specifications. Microbial specifications for solid oral or dry powder products may not be necessary if it can be justified in the application by establishing during product development that the product is at a very low risk of contamination and microbial growth is not supported. It is not a requirement that every batch of a product be tested at batch release. Once it has been demonstrated that the manufacturing processes do not permit contamination by excessive numbers of microorganisms, by testing a number of routine production batches to establish a product history, testing could be reduced to once every 6 to 12 months or on a selected basis (eg. every tenth batch). Products with a significant water content (eg. creams, gels and oral liquids) are likely to support microbial growth. Such products should include tests and limits for microbial content in both the batch release and expiry specifications. In addition, for products containing an antimicrobial preservative(s), both the batch release and expiry specifications should include physicochemical tests and limits for content of preservatives. Given that the effectiveness of many preservatives is pH dependent, the specifications for such products should usually include requirements for pH which will ensure preservative efficacy. Product modifications Sponsors may not implement changes to pharmaceutical data for registered products without prior approval from the TGA, except in accordance with Chapter 11, , and then only in accordance with the specified conditions.
must comply. The sterility tests published in editions of the BP and Ph. Eur. prior to 1998 are not acceptable. The TGA guidelines for sterility testing of therapeutic goods provide guidance for sterility testing of sterile therapeutic goods supplied in Australia for human use. These guidelines, however, are not mandatory for industry. Non-sterile products The (Chapter 4F) set out microbial limits which apply to non-sterile dosage forms. All non-sterile dosage should include limits for microbial content in the finished product batch release and expiry specifications. Microbial specifications for solid oral or dry powder products may not be necessary if it can be justified in the application by establishing during product development that the product is at a very low risk of contamination and microbial growth is not supported. It is not a requirement that every batch of a product be tested at batch release. Once it has been demonstrated that the manufacturing processes do not permit contamination by excessive numbers of microorganisms, by testing a number of routine production batches to establish a product history, testing could be reduced to once every 6 to 12 months or on a selected basis (eg. every tenth batch). Products with a significant water content (eg. creams, gels and oral liquids) are likely to support microbial growth. Such products should include tests and limits for microbial content in both the batch release and expiry specifications. In addition, for products containing an antimicrobial preservative(s), both the batch release and expiry specifications should include physicochemical tests and limits for content of preservatives. Given that the effectiveness of many preservatives is pH dependent, the specifications for such products should usually include requirements for pH which will ensure preservative efficacy. Product modifications Sponsors may not implement changes to pharmaceutical data for registered products without prior approval from the TGA, except in accordance with Chapter 11, , and then only in accordance with the specified conditions.