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Impact from the Recent Issuance of ANVISA Resolution RDC-53/2015 on Pharmaceutical Small Molecule Forced Degradation Study Requirements

Tattersall P; Asawasiripong S; Takenaka I; Castoro JA;

This paper, published in American Pharmaceutical Review, discusses the recent RDC-53/2015 regulation.

Forced degradation studies (FDS) are essential in the development of stability indicating methods to gain understanding of the intrinsic stability characteristics of a Drug Substance (DS). Guidance on forced degradation used by industry comes via formal documents from ICH, FDA, and publications/reviews on the topic. Recently, ANVISA published the RDC53/2015 regulation outlining specific requirements with regard to reporting, identification and qualification of degradation products. The extension of FDS requirements necessitated a review and update of current accepted practices, and assessment of its impact to previously filed and registered products to ensure compliance. The forced degradation requirements are discussed herein in relation to study design, reports and interpretation of such requirements.