3.2.P.1 DESCRIPTION AND COMPOSITION OF DRUG PRODUCT

3.2.P.1 Description and Composition of the Drug Product [{Drug Product Name}, {Dosage Form}] 1 A description of the drug product and its composition should be provided. The information provided should include, for example: Description of the dosage form. Composition (ie, list of all components of the dosage form and their amount on a per unit basis (including overages, if any)) the function of the components, and a reference to their quality standards (eg, compendial monographs or manufacturer’s specifications) Descriptions of accompanying reconstitution diluents. For a drug product supplied with reconstitution diluent(s), the information on the diluent(s) should be provided in a separate part “P”, as appropriate. Type of container and closure used for the dosage form and accompanying reconstitution diluent, if applicable Overfill information (Justification for overfill belongs in 3.2.P.2.2.1) Reference ICH guidances Q6A and Q6B. 3.2.P.1 Description and Composition of the Drug Product [{Drug Product Name}, {Dosage Form}] Guidance on Using this template Typographical Conventions Black Text Text (mostly headings) that agency reviewers are expecting to see in your document, based on the ICH guidances and EMEA guidelines. Red Text General guidance and instructions to authors, taken from ICH guidances and EMEA guidelines. Use this text to help you develop the appropriate content for your document. Can be turned on or off using the Show or Hide Hidden Text button on the StartingPoint toolbar. Highlighted Yellow Text Sample Text – wording or tabular format suggested by Octagon Research Solutions, based on our experience and best practices. 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A description of the drug product and its composition should be provided. The information provided should include, for example: Description of the dosage form. Composition (ie, list of all components of the dosage form and their amount on a per unit basis (including overages, if any)) the function of the components, and a reference to their quality standards (eg, compendial monographs or manufacturer’s specifications) Descriptions of accompanying reconstitution diluents. For a drug product supplied with reconstitution diluent(s), the information on the diluent(s) should be provided in a separate part “P”, as appropriate. Type of container and closure used for the dosage form and accompanying reconstitution diluent, if applicable Overfill information (Justification for overfill belongs in 3.2.P.2.2.1) Reference ICH guidances Q6A and Q6B. 2