Module 3 Presentations

07/05/2024

Guidelines for stability testing: EMA Guidelines (without adopted ICH guidelines and draft versions)

Reference Number

Title

EMA/CHMP/CVMP/QWP/4410 71/2011 Rev. 2 CPMP/QWP/122/02 Rev. 1 Corr. CPMP/QWP/609/96 Rev. 2

Stability testing for applications for variations to marketing authorisation Stability testing of existing active ingredients and related finished products Declaration of storage conditions for medicinal products particulars and active substances (Annex) In-use stability testing of human medicinal products Maximum shelf-life for sterile products for human use after first opening or following reconstitution

CPMP/QWP/2934/99

CPMP/QWP/159/96 Corr.

Source: EMA, https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/scientific-guidelines/quality-guidelines/quality stability

The Organisation for Professionals in Regulatory Affairs

45

Regional Stability Guidelines – Association of South East Asian Nations (ASEAN) – others Climatic zones and long term stability conditions

– Brazil – China – India – Eastern Mediterranean Region – South Africa – Southern Africa – Central America and Panama – Caribbean Islands

The Organisation for Professionals in Regulatory Affairs

46