Rejected materials

When materials are rejected, they should be clearly marked as such. Rejected materials should be stored separately and access to the area should be controlled. This is to prevent the accidental use or distribution of rejected materials.

Manufacturers can return rejected materials to the suppliers, destroy the materials or reprocess the rejected materials. The action the manufacturer initiates, should however be described and defined in a procedure. The action to be taken should be approved by authorized personnel. The action and approval must be recorded.

Reprocessing

Reprocessing of rejected materials should only be done in exceptional cases. It should only be allowed if the quality of the product is not negatively affected. The product must still comply with the specifications. During your inspections, you should assess the SOP to ensure that it clearly describes the manufacturer’s policy and procedure for reprocessing, as well as who will be responsible for evaluating the risks that are involved in reprocessing rejected material. Remember, proper and complete records should be maintained for reprocessed materials. A reprocessed batch should be given a new batch number. The manufacturer should also consider additional testing of reprocessed materials, e.g. stability testing of the batch.