Standard Operating Procedure for Sampling Raw Materials for Quality Testing

Department	Capsule Manufacturing
SOP No.	SOP/CM/002/2025
Supersedes	SOP/CM/002/2022
Page No.	Page 1 of 8
Issue Date	01/02/2025
Effective Date	05/02/2025
Review Date	01/02/2026

1. Purpose

To define the procedure for sampling raw materials to ensure they meet predefined quality standards before being used in capsule manufacturing.

2. Scope

This SOP covers the sampling process of raw materials, including APIs and excipients, for quality testing in capsule manufacturing.

3. Responsibilities

• Quality Control (QC) Personnel: Responsible for performing sampling, ensuring that all materials are sampled according to the specifications.
• Warehouse Personnel: Responsible for properly storing and handing over materials to QC for sampling.
• Quality Assurance (QA) Team: Ensures compliance with regulatory standards and approves sampling plans and procedures.
• Procurement Department: Ensures that materials are sourced from approved vendors, with correct documentation provided.

4. Accountability

The QC Manager is accountable for ensuring proper sampling procedures are followed. The QA Manager is responsible for overseeing compliance with regulatory standards.

5. Procedure

5.1 Preparation for Sampling

Before sampling, follow these steps to ensure that the environment and materials are properly prepared:

1. Verify that the raw materials are stored in a clean and suitable environment, free from contamination.
2. Ensure that all necessary documentation, such as the Certificate of Analysis (CoA), batch records, and vendor details, are available for review.
3. Review the sampling plan, which defines the number of samples to be taken, sampling points, and frequency.
4. Prepare all required sampling equipment (e.g., clean tools, sampling containers) and ensure they are free from contamination.

5.2 Sampling Procedure

Follow these steps to sample raw materials accurately and consistently:

1. Select Sampling Points
   1. Refer to the sampling plan to identify the number of containers to be sampled.
   2. For bulk materials, select samples from different parts of the container to ensure uniformity.
   3. For sealed containers, ensure that the seal is intact before sampling.
2. Perform Sampling
   1. Use appropriate clean and sterile sampling tools to collect the material from each selected point.
   2. Ensure that the samples represent the entire batch and are of sufficient quantity for testing.
   3. Label the samples clearly with details such as material name, batch number, date, and the sampler’s name.
3. Sample Storage
   1. Store the collected samples in suitable containers to maintain their integrity and prevent contamination.
   2. Ensure that samples are stored under the required conditions (e.g., temperature-controlled environments for temperature-sensitive materials).

5.3 Quality Control Testing

After sampling, the following steps should be followed for quality testing:

1. Testing
   1. Send the samples to the QC laboratory for testing as per the specifications defined in the approved test methods (e.g., pH, purity, microbial testing, etc.).
   2. Ensure all tests are performed according to validated methods and SOPs.
2. Test Results Evaluation
   1. Evaluate test results against the specified quality criteria outlined in the CoA.
   2. If the samples pass the test, they are approved for use in capsule manufacturing.
   3. If the samples fail the test, they must be rejected, and the batch is quarantined until further action is determined.

5.4 Documentation and Record Keeping

Ensure that all sampling activities are documented and recorded for traceability and compliance:

1. Complete the Sampling Log (Annexure-1) with all relevant details such as material name, batch number, sampling date, sampler’s name, and results of the tests.
2. Attach copies of the CoA, batch records, and test results with the corresponding sampling documentation.
3. Maintain records for all sampled materials in accordance with regulatory retention periods.

5.5 Handling Non-Conforming Materials

If any material does not meet quality standards, follow these steps:

1. Quarantine the material and label it as “Rejected” until further action is taken.
2. Prepare a Discrepancy Report (Annexure-2) detailing the issue and corrective actions.
3. Notify the Procurement team and the supplier for the return or replacement of the non-conforming materials.

6. Abbreviations

• SOP: Standard Operating Procedure
• CoA: Certificate of Analysis
• QC: Quality Control
• QA: Quality Assurance
• PO: Purchase Order

7. Documents

1. Sampling Log (Annexure-1)
2. Discrepancy Report (Annexure-2)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
• EU GMP Guidelines Part I – Basic Requirements for Medicinal Products

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Sampling Log

Date	Material Name	Batch Number	Sampler Name	Tests Performed	Result
02/02/2025	Capsule Material A	Batch 12345	John Doe	Moisture Content	Pass

Annexure-2: Discrepancy Report

Date	Material Name	Batch Number	Issue Description	Corrective Action
03/02/2025	Capsule Material B	Batch 56789	Out of Specification	Returned to Supplier

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP Creation	QA Head
01/02/2025	2.0	Document Format and Updates	Standardization	QA Head