SOP on Stability Studies

1.0 Purpose: This SOP describes the criteria for the stability studies of finished products.

2.0 Scope: This SOP applies to Quality Assurance staff.

3.0 Responsibility: Quality Assurance Manager to ensure that the procedure is followed.

4.0 Materials and Equipment: As required.

5.0 Procedure:  It is accepted that before any product is placed on the market, there must exist convincing evidence that during the time between its manufacture and its use by the consumer, it will not undergo any change that will adversely affect its performance, render it less acceptable to the consumer or cause it to represent a risk to the user i.e. it must be known to have an adequate shelf life.

Stability studies can be classified into three types – 

5.1 Accelerated Stability Studies: Studies, usually under accelerated conditions to predict a tentative shelf-life for a new or modified product or process. For a new drug substance these studies usually commence with a preformulation evaluation. The effect of stress conditions such as temperature, humidity and light provides useful information to manufacture a drug product.

 

The accelerated studies at elevated temperature allows extrapolation to provide a tentative shelf-life.

5.2. Storage Stability Studies:  Studies under conditions appropriate to the market, or those defined in the product labeling, are used to provide real time data for confirmation of the predicted tentative shelf-life.

5.3 Stability Studies on Concurrent Production: Studies are carried out for established products on some ongoing batches to confirm that current production is behaving in a similar manner. This is to detect the possible impact of any subtle or unknown changes to the component or process. In the event that a change is observed, it will be necessary to perform a root cause analysis.