Introduction to ICH :The Quality Guidelines :Q 1 – Stability Testing

• @ The “Q-Family” 

• Q 1 – Stability Testing 

• Q 2 – Analytical Validation 

• Q 3 – Impurities 

• Q 4 – Pharmacopoeias 

• Q 5 – Biotechnological Products 

• Q 6 – Specifications 

• Q 7 – Good Manufacturing Practices 

• Q 8 – Pharmaceutical Development 

• Q 9 – Quality Risk Management Q 

• 10 – Pharmaceutical Quality System 

ICH Q 1 – Stability Testing 

A set of originally five guidelines (Q1A to Q1F) defining - 

• General aspects of stability testing (storage conditions, batch size and number, length of time...) 
• Photostability
• Application to new dosage forms 
• Possibilities for reduced test designs (bracketing and matrixing)
• Statistical evaluation of stability data and possibilities for extrapolation 
• Storage conditions for stability testing in climatic zones III and IV (withdrawn)

ICH Q 1 A (R2) – Scope

• For new API and related medicinal products 
• To provide evidence on how the quality of an API/finished product changes with time under the influence of environmental factors such as temperature, humidity and light and to establish a re-test period/shelf-life for the API/finished product

ICH Q 1 A (R2) – In a Nutshell

• Stress testing required for API 
• Long-term and accelerated testing required for API and product, where necessary intermediate testing 
• Minimum of three representative batches 
• Testing over a minimum of 12 months at LT and 6 months at accelerated conditions (with defined testing frequency) 
• Storage conditions for the “general case”, aqueous products in semi-permeable containers, products to be stored in a refrigerator and a freezer 
• Stability commitment

ICH Q 1 B – In a Nutshell

• Describes requirements on photostability testing and defines light exposure to be applied 
• To be tested on API 
• if not photosensitive, no further testing required 
• If photosensitive, to be continued on exposed finished product and product in primary package, product in marketing package, where relevant 
• Where necessary, impact of light during manufacturing process to be evaluated 
• Confirmatory testing required, where applicable

ICH Q 1 C – In a Nutshell

• Additional guidance to ICH Q1 A(R2) on new dosage forms (“line extensions”) for new substances 
• Reduced requirements as regards time to be covered at LT storage conditions at time of dossier submissions

ICH Q 1 D – In a Nutshell

• Describes possibilities to apply reduced test designs, i.e. bracketing and matrixing 
• Defines situations where reduced testing can be applied without additional justification, with justification or where it is not applicable 
• Bracketing: testing of extremes only 
• Matrixing: testing of a different samples of factor combinations at different time points during the study 
• Provides example designs

ICH Q 2 – Analytical Validation will continue....next post..