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 3. Active pharmaceutical ingredient (s) (API): Section 3.4 Specifications

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 3.4 Specifications

API described in a pharmacopoeia:

Tests and limits should, as a minimum, comply with relevant pharmacopoeial requirements.

Provide a copy of the monograph together with any test methods referenced but not duplicated in the monograph.

Provide details of any specifications additional to those in the pharmacopoeia.

Provide certificates of analysis for at least two batches produced at each site of manufacture by each synthetic method, including results for impurities.

API not described in a pharmacopoeia:

A list of tests and limits for results for the API is needed.

Include test methods in sufficient detail for them to be replicated by another laboratory.

Results of validation of the methods for assay of the API and of impurities are needed.