1. Purpose
The purpose of this standard operating procedure (SOP) is to provide guidelines for the verification of all incoming raw materials before being accepted for use in manufacturing processes. The objective of this procedure is to ensure that only the high-quality raw materials that meet the specifications are used in the manufacturing processes.
2. Scope
This procedure applies to all the raw materials received at the manufacturing facility and applies to all personnel involved in the procurement, acceptance, and inspection of raw materials.
3. Responsibilities
The following personnel have defined responsibilities:
– Procurement: Responsible for ensuring that the raw materials are purchased from approved and reliable sources and that the procurement procedures are followed.
– Receiving: Responsible for accepting the incoming raw materials and the verification of compliance with specifications and purchase order requirements.
– QA/QC: Responsible for final inspection verification and the release of raw materials prior to use in the manufacturing process.
4. Procedure
4.1 Raw material acceptance
– Upon receipt of raw materials, verify that the total quantity received matches the quantity on the purchase order.
– The receiving personnel should physically verify the quantity of the delivered materials, ensuring that the product matches the product description and batch number on the packing list.
– The receiving personnel should visually inspect the product for any signs of damage, leakage, or contamination.
– Ensure that the raw materials are appropriately labeled, indicating product name, batch number, date of manufacture, and expiry date.
4.2 Raw material verification
– Verify that the documents provided with the shipment, such as the certificate of analysis, conform to the product specifications.
– Accept the product only if the material meets the specifications, including but not limited to parameters such as purity, identity, and physical characteristics.
– If the product fails to meet the specification, flag the product and notify the Quality assurance department accordingly.
4.3 Raw material sampling
– Take representative samples from the received materials for further testing.
– Document each sample, taking note of the quantity taken, the location and time of sampling, and the name of the sampling personnel.
4.4 Raw material storage
– Store the raw materials as per the manufacturer’s instructions in a manner that ensures the safety and quality of the product.
– Store the materials in designated areas with appropriate label information clearly indicating the name of the product, the batch number, and the date of receipt.
5. Abbreviations used
N/A
6. Documents
– Purchase orders
– Packing lists
– Certificate of analysis
– BMR (Batch manufacturing record)
7. SOP Version: 1.0