Specifications and control tests on the finished product - Scientific guideline

This guideline applies to human and veterinary medicines.

This document aims to facilitate the application of Part 2, section E of the Annex to Directive 75/318/EEC, as amended. It provides guidance on the information to be included in the marketing authorisation application on specifications and control test on the finished product.

Keywords: Specification, finished product, chemical, control, test, acceptance criteria, limit, release

Current effective version

Specifications and control tests on the finished product

Adopted Reference Number: 3AQ11A Legal effective date: 01/06/1992