materials are received.

4. Accountability

The Warehouse Supervisor is accountable for ensuring that raw materials are properly stored and labeled. The QC Manager is accountable for ensuring that sampling is conducted according to this SOP, and the Procurement Team is accountable for ensuring that only approved materials are procured.

5. Procedure

5.1 Pre-Sampling Preparation

1. Verify that raw materials are received according to the specifications outlined in the purchase order. Ensure that the correct quantity and type of materials have been delivered.
2. Ensure that all raw materials are stored in a clean, dry, and temperature-controlled environment as per storage guidelines.
3. Prepare the sampling equipment, including clean sampling containers, tools, and labeling materials, to avoid contamination of the sample.
4. Ensure that the raw material’s Certificate of Analysis (CoA) and any necessary safety data sheets (SDS) are available for review before sampling.

5.2 Sampling Procedure

1. Identify the correct sampling point, ensuring that the sample represents the entire lot. For bulk materials, take multiple samples from different locations within the container or lot to ensure uniformity.
2. For solid raw materials, use clean, dry scoops or sampling tools to collect the sample. For liquids, use clean pipettes or sample containers that are designed for liquid sampling.
3. Ensure that the sample size is sufficient for laboratory analysis. The sample size should be according to the type of material and the testing requirements as per the approved sampling plan.
4. Collect the sample while ensuring minimal exposure to environmental contaminants. Seal the sample container immediately after collection and label it with the following details:
   • Material name
   • Batch or lot number
   • Supplier’s name
   • Date of sampling
   • Sample number
5. Store the sample under appropriate conditions until it is delivered to the QC laboratory for testing.

5.3 Sampling of Bulk Materials

1. For bulk materials, ensure that the container or storage vessel is well mixed before taking the sample. If necessary, use mechanical mixers to ensure uniformity before sampling.
2. Ensure that the sampling tools are inserted to various depths to obtain a representative sample from different parts of the bulk material.
3. After sampling, seal the sampling equipment and the sample container to avoid contamination and ensure the integrity of the sample.

5.4 Post-Sampling Activities

1. After sampling, record the details of the raw material lot, sample number, date, and sampling method in the Raw Material Sampling Log (Annexure-1).
2. Transfer the sample to the QC laboratory for testing. Ensure that the sample is properly labeled and tracked through the testing process.
3. Notify the QC team to initiate testing and ensure that the material meets the required specifications outlined in the CoA and the approved product formula.
4. If any deviations or non-conformances are identified during sampling, document the issue in the Deviation Log (Annexure-2) and take corrective actions as necessary.

5.5 Documentation and Record-Keeping

1. Maintain accurate records of the raw material sampling process, including the Raw Material Sampling Log (Annexure-1) and the Deviation Log (Annexure-2) for any issues encountered during sampling.
2. Ensure that all sample labels are properly documented and stored for traceability in case of audits or regulatory inspections.
3. All sampling documentation must be reviewed and approved by the QC Manager to ensure compliance with internal and regulatory standards.
4. Retain all documentation for a minimum of two years or as required by regulatory guidelines.

6. Abbreviations

• GMP: Good Manufacturing Practices
• QC: Quality Control
• QA: Quality Assurance
• PPE: Personal Protective Equipment
• CoA: Certificate of Analysis
• SDS: Safety Data Sheet

7. Documents

1. Annexure-1: Raw Material Sampling Log
2. Annexure-2: Deviation Log

8. References

• Good Manufacturing Practices (GMP) Guidelines – 21 CFR Part 211
• International Conference on Harmonisation (ICH) Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• Manufacturer’s Manual for Sampling Equipment

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Raw Material Sampling Log

Batch Number	Material Name	Sampling Date	Sample ID	Operator
12345	Active Ingredient A	21/01/2026	S-001	John Doe

Annexure-2: Deviation Log

Deviation Date	Batch Number	Deviation Description	Corrective Action Taken	Operator
21/01/2026	12345	Incorrect sample size	Adjusted sample volume	Jane Smith

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/03/2024	1.0	Initial Version	New SOP Creation	QA Head
01/03/2025	2.0	Format Revision and Updates	Standardization of Document	QA Head