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 3.5 Stability testing

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)

Índice de contenido

	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 3.5 Stability testing

Provide the results of stability testing of the API.

Describe the methodology used during stability studies; if this is identical to methodology described elsewhere in the data set, a cross-reference will suffice. If different methodology was used, provide validation of tests for impurities and assay and for other tests as necessary.

For well established API, studies should be conducted according to WHO¹ Guidelines. For new API and products, ICH² guideline should be used. Results should be included for physical as well as chemical tests, e.g., (where relevant) particle size and polymorph form.

¹ WHO Expert Committee on Specifications for Pharmaceutical Preparations, Thirty-fourth report. Geneva, World Health Organization, 1996: 65-79 (WHO Technical Report Series, No 863).

² http://www.ifpma.org/ich5q.html#stability

Indicate the proposed shelf-life (or retest date) that is justified by the stability testing.