Deriving and assessing stability data for medicines

Guidance

The NHS Pharmaceutical QA Committee has published five standard protocols to advise on
– designing and undertaking stability studies
– evaluating the suitability of published stability studies
– evaluating stability data provided by suppliers of unlicensed medicines

Attachments

• Standard Protocol for Deriving and Assessment of Stability: Part 1 - Aseptic Preparation (small molecules)Opens in a new window · PDF · 307 KB
• Standard Protocol for Deriving and Assessment of Stability: Part 2 - Aseptic Preparations (Biopharmaceuticals)Opens in a new window · PDF · 784 KB
• Standard Protocol for Deriving and Assessment of Stability: Part 3 - Oral Liquid MedicinesOpens in a new window · PDF · 159 KB
• Standard Protocol for Deriving and Assessment of Stability: Part 4 - Parenteral NutritionOpens in a new window · PDF · 488 KB
• Standard Protocol for Deriving and Assessment of Stability: Part 5 - Sterile ProductsOpens in a new window · PDF · 290 KB