12. Product Specifications The product specification is a description of the product formulation, and the tests to be applied to batches of the product. The statement should contain (or make reference to): name of product; dosage form; product code; date of specification; revision or version number; name and signature of the appropriate company official; description of physical appearance; detail of physical tests performed (and limits) including total weight, weight variation, tests and limits, disintegration tests and limits; stage of manufacture; packaging type and closure; recommended storage conditions; recommended shelf-life; and details of the full formulation including all active and all excipient ingredients (including coatings and capsule ingredients). For every ingredient: give the Australian Approved Name (AAN); the quality standard and / or grade; state any overages used; the nominal (label claim) amount: Clearly identify whether the amount of substance is expressed in terms of the salt / complex, or base. If the label claim is not in the same terms, the amount in terms of the label statement should also be stated; and If the ingredient is herbal, the (Chapter 1, Section 3 Herbal Substances) offers useful – guidance. Include, for example, the botanical species, plant part and, if an extract, state the amount of the extract, the strength of the extract, and the equivalent amount of dried plant. The extracting solvent and diluting medium should also be described. Guidance on the identification of herbal materials and extracts is provided in the document titled Questions & Answers for the Identification of Herbal Materials and Extracts, available at <> on the TGA website; and If direct compression (DC) tableting materials are used, then, as with herbal extracts, describe the amount of DC material used, its equivalence to active substance, and describe the diluent.
12. Product Specifications The product specification is a description of the product formulation, and the tests to be applied to batches of the product. The statement should contain (or make reference to): name of product; dosage form; product code; date of specification; revision or version number; name and signature of the appropriate company official; description of physical appearance; detail of physical tests performed (and limits) including total weight, weight variation, tests and limits, disintegration tests and limits; stage of manufacture; packaging type and closure; recommended storage conditions; recommended shelf-life; and details of the full formulation including all active and all excipient ingredients (including coatings and capsule ingredients). For every ingredient: give the Australian Approved Name (AAN); the quality standard and / or grade; state any overages used; the nominal (label claim) amount: Clearly identify whether the amount of substance is expressed in terms of the salt / complex, or base. If the label claim is not in the same terms, the amount in terms of the label statement should also be stated; and If the ingredient is herbal, the (Chapter 1, Section 3 – Herbal Substances) offers useful guidance. Include, for example, the botanical species, plant part and, if an extract, state the amount of the extract, the strength of the extract, and the equivalent amount of dried plant. The extracting solvent and diluting medium should also be described. Guidance on the identification of herbal materials and extracts is provided in the document titled Questions & Answers for the Identification of Herbal Materials and Extracts, available at <> on the TGA website; and If direct compression (DC) tableting materials are used, then, as with herbal extracts, describe the amount of DC material used, its equivalence to active substance, and describe the diluent.
cm-argcm-p4-110825.docx