1. Purpose:
The purpose of this standard operating procedure (SOP) is to outline the procedures and guidelines for testing raw materials in order to ensure that they meet the required specifications. Raw material testing is an essential part of the production process to maintain product quality, safety and consistency.
2. Scope
This SOP applies to all raw materials used in the production process, including but not limited to powders, liquids, and gases.
3. Responsibility
The responsibility for the testing of raw materials lies with the Quality Control Department.
4. Procedure
a. Receipt of Raw Materials: All incoming raw materials must be accompanied by a CoA (Certificate of Analysis) which should include the details of the supplier, the batch number, and the specifications of the material. The QC Department should verify the authenticity of the CoA and ensure that it is in compliance with the approved specifications.
b. Sampling: Once the raw material has been verified, the QC Department should take samples as per the sampling plan and transfer them to the laboratory. The sample size should be sufficient to carry out all the required tests. The sampling should be carried out in a clean environment that is free from any contamination.
c. Testing: The QC Department should conduct various tests on the raw material depending upon its specifications. The tests may include but are not limited to:
• Physical tests- Appearance, color, odor, particle size, density, and specific gravity.
• Chemical tests- pH, acid value, water content, and purity.
• Microbiological tests- Total viable count, microbial limits, and endotoxin content.
d. Recording of results: All test results should be recorded in a logbook or on a computer system. The results should be reviewed by the QC Department and verified by the QA Department before they can be approved.
e. Rejection of Materials: Raw materials that fail to meet the specifications should be rejected immediately. The supplier should be informed about the non-compliance, and the rejected batches should be segregated and kept in quarantine. A decision regarding the disposition of the products should be taken as per the approved procedures.
f. Release of Material: Only those raw materials that have passed all the required tests and have been approved by the QC and QA Departments should be released for use in the production process.
5. Documentation
All raw material testing reports, CoAs, and test results should be kept on record as per the approved procedures.
6. Training
All staff members involved in the testing of raw materials should receive training on this SOP, including the procedures and the importance of adhering to the approved specifications.
7. Change Control
Any changes made to this SOP should be communicated to all relevant personnel, and it should be updated as per the approved procedures.
8. Conclusion
This SOP provides the guidelines and procedures for the testing of raw materials to ensure that they meet the required specifications. It is the responsibility of all staff members involved in this process to adhere to the procedures outlined in this SOP to maintain product quality and safety.
