1. Purpose:
The purpose of this SOP is to outline the procedure for returning raw materials that are deemed unusable or do not meet the required specifications.
2. Scope:
This SOP applies to all employees who handle or are involved in the return of raw materials.
3. Responsibility:
The Quality Control department shall be responsible for initiating the raw material return process and ensuring that the procedure is followed.
4. Procedure:
4.1 Raw materials that do not meet the required specifications or are damaged during transportation should be identified and isolated immediately.
4.2 The Quality Control department shall be informed of the identified raw materials for further investigation.
4.3 The Quality Control department shall conduct an inspection of the identified raw materials to determine the root cause of the issue.
4.4 If the raw material is deemed unusable or unsatisfactory for use in the manufacturing process, the Quality Control department shall initiate a raw material return request.
4.5 Upon approval of the raw material return request, the inventory department shall be notified of the return and asked to provide a return authorization number.
4.6 The raw materials shall be securely packaged and labeled with all the necessary information, including the return authorization number, batch number, and any other relevant information.
4.7 The raw
4.8 The Quality Control department shall ensure that the returned raw materials are properly inspected and approved before it is sent back to the supplier.
4.9 The raw materials return record shall be maintained, which includes information such as the supplier name, batch number, date of receipt, date of return, reason for return, and any relevant investigation reports.
4.10 The supplier shall be informed of the return, and the necessary documentation shall be shared with them.
5. References:
The procedure outlined in this SOP adheres to the requirements specified in the cGMP guidelines, company SOPs, and regulatory requirements.
6. Revision History:
This SOP shall be reviewed annually, and revisions made as necessary to ensure that the process remains effective and current with the company’s needs and regulatory requirements. Any revision made to this SOP shall be communicated to all relevant personnel.
