Expiry and retest dating
Article 49
1. Where an intermediate is intended to be transferred outside the control of the manufacturer and an expiry or retest date is assigned, supporting stability information shall be available (e.g. published data, test results). 2. The expiry or retest date of an active substance shall be based on an evaluation of data derived from stability studies. 3. Preliminary active substance expiry or retest dates may be based on pilot scale batches where the following conditions are fulfilled: (a) the pilot batches employ a method of manufacture and procedure that simulates the final process to be used on a production scale; (b) the quality of the active substance represents the material to be made on a production scale.