Analytical procedure validation for complementary medicines
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.
Analytical procedure validation - starting materials
Test procedures for starting materials used in complementary medicines must use analytical methods that are validated for that purpose. In determining the minimum validation activities to be applied to a test procedure, a risk-based assessment should be undertaken.
This guideline document describes the minimum approach acceptable to achieve validation of the test procedure used for starting materials for use in complementary medicines.
Starting material analytical procedure validation for complementary medicines (pdf,116kb)
Analytical procedure validation - finished products (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. Only starting materials which are approved by the testing facility (for example, the manufacturer of the medicine or contracted testing laboratory) using suitably validated tests, can be used as ingredients in medicines. In determining the minimum validation activities to be applied to a test procedure, a risk-based assessment should be undertaken.
This guideline document describes the minimum approach acceptable to achieve validation of the test procedure used for complementary medicines (products).
Finished product (medicine) analytical procedure validation for complementary medicines (pdf,117kb)