1.0 Purpose: This SOP describes the procedure for handling of rejected materials and products

2.0 Scope: This SOP applies to Stores In-charge and Quality Control staff.

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

4.0 Materials and Equipment: As required.

For Raw Materials: Raw materials are normally received from a reliable source but even then company analyse all components qualitatively and quantitatively. On the basis of analysis of raw materials, quality control department issued a raw material test report to raw material store. Raw materials which are “Rejected” are returned from quarantine area to the supplier according to established procedure.

Packaging Components: Rejected packaging components are identified and kept under a quarantine system designed to prevent their use in manufacturing or processing operations for which they are unsuitable. The rejected drug product containers and closures are returned from the quarantine area to the supplier according to established procedures. The rejected printed packaging materials are destroyed by the company in the presence of supplier’s representative.

Finished Products: Rejected finished products are clearly marked and stored separately in the area for rejected goods. Rejected or out of specification products may be reprocessed if quality assurance permits. The quality assurance must ensure that in reprocessing quality of the final product is not affected, all the specifications are met and it is done in accordance with a defined established procedure after evaluation of the risks involved. When the rejected products do not conforms to the specifications and safety evaluation, they are destroyed according to SOP.