safety protocols are followed, especially when handling chemicals or hazardous materials during the sampling process.

Laboratory Team: Responsible for conducting tests in accordance with established methods and ensuring that the results are documented accurately and promptly.

4. Accountability

The Manufacturing Manager is accountable for ensuring that this SOP is followed during the sampling and testing processes. The overall compliance with this SOP is under the supervision of the Quality Assurance (QA) Manager.

5. Procedure

5.1. Sampling of Raw Materials

1. At the beginning of the manufacturing process, collect representative samples of all raw materials before they are used in production.
2. Ensure that samples are taken from the designated sampling points as specified in the raw material handling procedures.
3. Use clean, sterilized sampling tools to avoid contamination of the raw materials. Record the details of the sample, including the material name, batch number, and date of sampling, in the Raw Material Sampling Log (Annexure-1).
4. Send the collected samples to the QC laboratory for testing in accordance with the material specification sheets and the company’s testing protocols.
5. Do not proceed with manufacturing until raw materials have been tested and approved by the QC team.

5.2. In-Process Sampling and Testing

1. During each stage of the manufacturing process (e.g., formulation, filling, packaging), collect samples of in-process materials to ensure they meet the required specifications.
2. Sample size and frequency should be determined based on the stage of manufacturing and the nature of the material. Sampling should occur at regular intervals or at critical points where deviations could affect product quality.
3. Record the sample details, including the manufacturing stage, time, and batch number, in the In-Process Sampling Log (Annexure-2).
4. Send the in-process samples to the QC laboratory for testing, including but not limited to, viscosity, pH, and appearance, as required by the product specifications.
5. If any in-process material fails to meet the specifications, stop the production process, investigate the cause, and implement corrective actions as necessary.

5.3. Final Product Sampling and Testing

1. After the filling and packaging stages, collect representative samples of the finished aerosol cans for final product testing.
2. Samples should be taken from different parts of the batch to ensure a comprehensive representation of the entire production run.
3. Record the sample details, including the batch number, production date, and operator’s name, in the Final Product Sampling Log (Annexure-3).
4. Perform testing on the final product to verify that it meets the required specifications for product weight, appearance, spray pattern, sealing, and any other quality attributes.
5. If the final product does not meet the specifications, initiate a root cause analysis and take appropriate corrective and preventive actions (CAPA).

5.4. Documentation of Test Results

1. Ensure that all test results from raw material, in-process, and final product testing are documented and filed according to the company’s record-keeping policies.
2. Record all results in the relevant testing logs (Raw Material Sampling Log, In-Process Sampling Log, and Final Product Sampling Log) and include the results of the laboratory tests, as well as any deviations or non-conformances found during testing.
3. Document any corrective actions taken in response to failed tests and ensure that these are reviewed and approved by the appropriate personnel.

5.5. Review and Approval of Test Results

1. Once the testing is complete, the QC team should review all test results to ensure that they meet the required quality standards.
2. If the test results are satisfactory, the batch can be approved for the next stage of production (e.g., packaging and shipping).
3. If the test results indicate any issues, the batch should be put on hold, and corrective actions should be implemented. The batch can only proceed after all issues are resolved and documented.
4. The results and approval or rejection of the batch should be documented in the Batch Record (Annexure-4), including the batch number, testing results, and any corrective actions taken.

5.6. Documentation and Record-Keeping

1. Ensure that all sampling and testing documentation is complete, accurate, and stored securely according to the company’s document retention policy.
2. All records should be available for inspection by internal and external auditors, as well as regulatory agencies, as needed.
3. Review the documentation regularly to ensure compliance with GMP guidelines and company policies.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QC: Quality Control
• PPE: Personal Protective Equipment
• SOP: Standard Operating Procedure

7. Documents

1. Raw Material Sampling Log (Annexure-1)
2. In-Process Sampling Log (Annexure-2)
3. Final Product Sampling Log (Annexure-3)
4. Batch Record (Annexure-4)

8. References

This SOP is based on the following regulatory guidelines and industry standards:

• Good Manufacturing Practice (GMP) Guidelines
• FDA Code of Federal Regulations (CFR) Title 21, Part 211
• ISO 9001:2015 – Quality Management Systems
• International Pharmacopoeia (Ph. Int.) – Aerosol Delivery

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

Material Name	Batch No.	Sampling Date	Sampled By	Test Results
Solvent A	12345	06/02/2025	Rajesh Patel	Pass

Annexure-2: In-Process Sampling Log

Stage	Sample ID	Sampling Date	Operator Name	Test Results
Formulation	F-12345	06/02/2025	Rajesh Patel	Pass

Annexure-3: Final Product Sampling Log

Batch No.	Sample ID	Sampling Date	Operator Name	Test Results
12345	FP-12345	06/02/2025	Rajesh Patel	Pass

Annexure-4: Batch Record

Batch No.	Sampling Date	Test Results	Corrective Actions	Approval
12345	06/02/2025	Pass	None	Approved

12. Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By	Page No.	Ref. Point No.	Details of Revision
01/01/2024	V 1.0	Initial Release	First Issue	Anjali Sharma	Page 1	[Ref Point]	First Release
01/01/2025	V 2.0	Updated sampling and testing procedures	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures