Guidelines for the Compilation of a Product Dossier for Submission in the Assessment Procedure for New and Multi-Source (Generic) Products Used in the Treatment of Malaria: Section 4. Finished product: Section 4.1 Formulation

Guidelines for the Compilation of a Product Dossier for Submission in the Assessment Procedure for New and Multi-Source (Generic) Products Used in the Treatment of Malaria
(11 pages)

Table of Contents

	Section 1. Details of the product
	Section 2. Regulatory situation in other countries
	Section 3. Active pharmaceutical ingredient (s) (API)
		Section 3.1 Properties of the active pharmaceutical ingredient(s)
		Section 3.2 Sites of manufacture
		Section 3.3 Route(s) of synthesis
		Section 3.4 Specifications
		Section 3.5 Stability testing
	Section 4. Finished product
		Section 4.1 Formulation
		Section 4.2. Sites of manufacture
		Section 4.3 Manufacturing procedure
		Section 4.4 Specifications for excipients
		Section 4.5 Specifications for the finished product
		Section 4.6 Container/closure system(s) and other packaging
		Section 4.7 Stability testing
		Section 4.8 Container labelling
		Section 4.9 Product information
		Section 4.10 Patient information and package inserts
		Section 4.11 Justification for any differences to the product in the country or countries issuing the submitted WHO-type certificate(s)⁶
	Section 5. Efficacy and safety
		Section 5.1 Bio-equivalence study report
		Section 5.2 Artemisinin containing drug products
		Section 5.3 Summary of pharmacology, toxicology and efficacy of the product

Section 4.1 Formulation

Provide the formulation for a typical batch and for an administration unit, e.g. one tablet, 5 ml of oral solution, or the contents of an ampoule or bag of large volume parenteral solution, etc.

Include excipients that may be removed during processing, those that may not be added to every batch (e.g. acid and alkali), and the qualitative and quantitative composition of any tablet coating, capsule shell and inked imprint on the dosage form. State any overages. State the function(s) of each excipient (e.g. antioxidant, lubricant, binder).

Indicate any substances whose content may be varied (e.g. inked imprint, tablet coating). Ranges in the content of excipients need justification and explanation how the content is decided for each batch.