1. Purpose:
The purpose of this SOP is to outline the quarantine procedure for raw materials received at the facility and ensure that they are appropriately screened before entering the production process.
2. Scope:
This procedure applies to all raw materials and packaging materials received at the facility.
3. Responsibilities:
The Quality Control (QC) department is responsible for the implementation of this procedure. The supplier must also adhere to this procedure and provide all the necessary documentation.
4. Procedure:
4.1 Receipt of Raw Materials:
All received raw materials must be verified by the receiving personnel against the purchase order and delivery documents, which should include the specifications, quantity, and other relevant documents. Once verified, the raw materials should be labeled with a unique identifier, such as a quarantine label, and stored in the designated quarantine area.
4.2 Initial Inspection:
The QC department is responsible for inspecting the raw materials to ensure they meet the required specifications laid out in the purchase order. The inspection should include checking for physical appearance, packaging, labeling, and any other relevant specifications. If any deviations are observed, they must be documented.
4.3 Sampling and Testing:
After the initial inspection, the QC department must conduct appropriate sampling and testing to verify the quality of the raw materials. The sampling and testing plan should be based on the appropriate sampling plan specified in the purchase order. The samples should be labeled, properly secured, and stored at the appropriate conditions until tested.
4.4 Release or Rejection:
Based on the results of the tests, the QC department will decide whether to release the raw materials for use or reject them. In case of rejection, the supplier will be informed and asked to replace the rejected materials with acceptable ones.
4.5 Release of Raw Materials:
After determining that the raw materials are acceptable for use, they can be released from quarantine to the designated storage area.
4.6 Record Keeping:
All tests, inspections, and decisions must be adequately documented using the appropriate forms or templates provided by the QC department. The documentation should include the raw material’s name, batch number, supplier, and test results.
5. Reference Documents:
This procedure refers to the following documents:
– Purchase order
– Delivery documents
– Appropriate sampling and testing plan
– SOPs on raw materials handling, testing, and storage
6. Revision History:
The SOP is subject to revision based on regulatory requirements, feedback, or as needed. Any changes made to the procedure will be appropriately documented and communicated.