SOP on Storage of Reserve Samples

SOP on Storage of Reserve Samples
1.0 Purpose: This SOP describes the procedure for keeping the reserve samples of active raw materials and finished product batches.
2.0 Scope: This SOP applies to Production Staff and Quality Control Staff.
3.0 Responsibility: Quality Control Manager to ensure that the procedure is followed.
4.0 Materials and Equipment: As required
5.0 Procedure:
5.1.0 Raw Materials 
5.1.1 An appropriate identified reserve sample that is representative of each lot in each shipment of each active ingredient is retained.
5.1.2 The reserve sample consists of at least twice the quantity necessary for all tests required to determine whether the active ingredient meets its established specifications.
5.1.3 For an active ingredient in an OTC drug product that is exempt from bearing an expiration date, the reserve sample is retained for 3 years after distribution of the last lot of the drug product containing the active ingredient.
5.1.4 If a batch of ingredient is delivered on more than one occasion samples from each delivery are retained.   
5.2.0 Finished Product
5.2.1 An appropriate identified reserve sample that is representative of each lot or batch of drug product is retained and stored under conditions consistent with the product labeling.
5.2.2 The reserve sample is stored in the same immediate container-closure system in which the drug product is marketed or in one that has essentially the same characteristics.
5.2.3 The reserve sample consists of at least twice the quantity necessary to perform all the required tests.
5.2.4 The reserve sample is retained for 6 months after the expiration date of the drug product.
5.2.5 For large pack sizes, where product costs and storage space is a problem, it is acceptable to retain the sample in a smaller version of the immediate container-closure system.
5.3.0 Storage Conditions: The actual storage conditions for retained samples would seem appropriate to use conditions which are reasonably related to those likely to be experienced by the commercial product. However, this would not be appropriate for the product required specific storage conditions.
5.4.0 Re-Examination
5.4.1. The reserve samples are completely tested after the expiry date of the product. 
5.4.2 Any evidence of the reserve sample deterioration is investigated.
5.4.3 The results of the examination are recorded and maintained with other stability data on the drug product.
5.4.4 Evaluation of all retained batches is a time consuming service and as a consequence only statistically selected number of batches are evaluated.

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