Finished pharmaceutical products

Norma técnica: Guía de especificaciones de producto farmacéutico terminado (Technical Standard: Guide to specifications for finished pharmaceutical products) (37 pages, in Spanish)

The notified guide seeks to contribute to establishing a set of comprehensive specifications for pharmaceutical products. It provides guidance on establishing and justifying acceptance criteria, and selecting analytical testing procedures for pharmaceutical products produced from active substances of synthetic or biological origin.

Pursuant to Ministry of Health Supreme Decree No. 3 of 2010, approving the Regulations of the National Control System for Products for Human Use, the specifications are set out in a technical document that defines the attributes of a raw material, material, product, service or other, and determines which of their variables must be evaluated, describing all the tests, trials and analyses used to determine and establish the acceptance or rejection criteria (Article 5(29)). As such, the specifications are critical quality standards that are proposed and justified by the manufacturer/registration holder, and approved by the Chilean Public Health Institute as compliance conditions.