Skip to content
Arab Experts’ OfficeArab Union of Manufacturers of Pharmaceuticals and Medical Appliancesالعربية

Manufacturing and quality

Stability and shelf life

At the check date, EMA lists Q1A(R2) as effective and consolidated Q1 as a Step 2b draft. Distinguish draft proposals from adopted product and market requirements.

Sources and scope checked: 3 October 2026 · Guide version 1

Scope: Do not generalise one stability condition or shelf life to every product and market.

View my progressPractise in the lab

Prepare your evidence before a decision

Mark the prompts for which you have organised evidence. Completion tracks preparation; it does not establish product or site compliance.

You can use and print this checklist without electronic saving.

Ticks are saved only in this browser. No documents or patient data are sent. The download includes prompt status and source links.

Continue to practice

Open the related tool or pathwaySearch Office resources