Retention of samples
Article 50
1. Reference samples shall be kept for the purpose of potential future evaluation of the quality of batches of active substance and not for future stability testing purposes. 2. Reference samples of each active substance batch shall be retained for one year after the expiry date of the batch, or for three years after distribution of the batch, whichever is the longest. 3. For active substances with retest dates, reference samples shall be retained for three years after the batch is completely distributed by the manufacturer. 4. Reference samples shall be stored in the same packaging system in which the active substance is stored or in one that is equivalent to or more protective than the marketed packaging system. 5. Sufficient quantities shall be retained to conduct at least two full compendial analyses or, when there is no pharmacopoeial monograph, two full specification analyses.