These guidance documents describe the minimum approach considered to be acceptable to achieve validation of the test procedures used for complementary medicines (products) and starting materials for use in complementary medicines. Each document also contains details of mandatory validation requirements, a glossary of terms, references and a flow chart to assist in determining the need for validation.
Guidance development
Draft documents were prepared by the Office of Complementary Medicines (OCM) / Industry Consultation Group (OICG) with input from other areas of the TGA. The draft documents were then circulated to the industry associations requesting comment on behalf of their members.
The OICG reviewed the comments received from industry and amended the documents to reflect agreed changes.
Scope
This guidance does not extend to medicines other than complementary medicines nor is it applicable to other medicines containing a complementary medicine component.
- Starting material analytical procedure validation for complementary medicines
Test procedures for starting materials used in complementary medicines must use analytical methods that are validated for that purpose. - Finished product (medicine) analytical procedure validations for complementary medicines
Testing of complementary medicines, either at initial release or during a stability study must use analytical methods which are appropriately validated for that purpose.