Standard Operating Procedure (SOP) for Raw Material Sampling and Testing

Standard Operating Procedure (SOP) for Raw Material sampling and testing

1. Purpose

  • To establish a systematic procedure for the sampling and testing of raw materials to ensure their quality and compliance with specifications before use in production.

2. Scope

  • This SOP applies to all personnel involved in the sampling and testing of raw materials at [Company Name].

3. Responsibilities

  • Quality Control Manager: Overall responsibility for ensuring adherence to this SOP.
  • Production Supervisor: Coordinate with the Quality Control department for sampling and testing.
  • Quality Control Technician: Conduct sampling and testing as per the SOP.
  • Procurement Officer: Ensure raw materials are obtained from approved suppliers.

4. Equipment and Materials

  • Clean containers for sample collection
  • Sampling tools (e.g., scoops, pipettes)
  • Testing equipment (e.g., pH meter, moisture analyzer)
  • Personal protective equipment (PPE) – gloves, lab coat, safety goggles

5. Procedure

5.1 Raw Material Sampling

  1. Obtain the sampling plan from the Quality Control Manager, specifying the frequency and locations for sampling.
  2. Ensure sampling tools and containers are clean and sterile before use.
  3. Identify the sampling points on the raw material containers or packages.
  4. Take samples according to the prescribed method, ensuring representative samples are collected.
  5. Label each sample with the following information:
    • Date and time of sampling
    • Name of the sampler
    • Raw material name and code
    • Sampling location
  6. Transfer the samples to the Quality Control laboratory for testing.

5.2 Raw Material Testing

  1. Receive the samples in the Quality Control laboratory.
  2. Verify the integrity of the samples and cross-check with the accompanying documentation.
  3. Conduct the necessary tests based on the specifications provided for each raw material.
  4. Perform tests using appropriate equipment and following standard test methods.
  5. Record the test results accurately, including any deviations from the expected values.
  6. Compare the test results with established acceptance criteria.
  7. Notify the Quality Control Manager immediately of any non-conforming results.
  8. Document all test results and maintain records in accordance with company procedures.

6. Reporting and Documentation

  • Prepare a test report for each batch of raw material tested, including:
    • Date of testing
    • Raw material details
    • Test methods used
    • Test results
    • Acceptance status
  • File the test reports for future reference and audits.

7. Non-Conformance and Corrective Action

  • If any raw material fails to meet the acceptance criteria:
    • Quarantine the material to prevent its use in production.
    • Initiate a non-conformance report and investigate the root cause.
    • Implement corrective actions to prevent recurrence.

8. Training

  • Ensure all personnel involved in sampling and testing receive adequate training on this SOP and related procedures.

9. Records Retention

  • Maintain all sampling and testing records for a minimum period as per regulatory requirements or company policy.

10. Revision History

  • Document any revisions made to this SOP and ensure all affected personnel are informed.

11. References

  • List any relevant standards, guidelines, or regulatory requirements applicable to raw material sampling and testing.

12. Approval

  • This SOP must be approved by the Quality Control Manager or designated authority before implementation.

13. Distribution

  • Distribute copies of this SOP to all relevant personnel and ensure they have access to the most recent version.

14. Review

  • Periodically review and update this SOP to reflect changes in processes, equipment, or regulatory requirements.
  • For more articles, Kindly Click here.
  • For pharmaceutical jobs, follow us on LinkedIn
  • For Editable SOPs in word format contact us on info@pharmaceuticalcarrier.com
  • For more information kindly follow us on pharmaguidelines.co.uk

Leave a Comment

Your email address will not be published. Required fields are marked *