ensuring that the equipment used for sample collection, such as filling machines and sample containers, is calibrated and maintained for proper function.

4. Accountability

The Manufacturing Manager is accountable for ensuring that in-process sampling is performed in compliance with this SOP. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Pre-Sample Collection Preparation

1. Verify that the aerosol containers have completed the appropriate stages of production (e.g., filling, crimping) before samples are collected.
2. Prepare necessary equipment for sample collection, including:
   • Sample containers (e.g., vials, sample bottles)
   • Labeling materials for proper identification of samples
   • Sampling tools (e.g., pipettes, syringes)
   • PPE, including gloves, goggles, and lab coats
3. Ensure that the sample collection equipment is clean and sterile to avoid contamination.
4. Confirm that the sample collection process does not interfere with the ongoing production or create any risks to product quality or safety.

5.2. Collecting In-Process Samples

1. Collect samples at predefined intervals during the production process. The sample collection points may include:
   • After filling the aerosol cans to check for fill weight and propellant levels
   • After crimping to verify valve attachment and crimp integrity
   • At the final stages of production before packaging to evaluate overall quality
2. For each sample collection:
   • Label the sample containers with the relevant information, such as batch number, collection time, and stage of production.
   • Collect an adequate volume of the sample to perform necessary analysis (e.g., 50 mL for chemical analysis, 1 aerosol can for visual inspection).
   • Ensure that the collected sample is representative of the batch and production conditions.
3. Ensure that the samples are handled carefully to avoid contamination or loss of product integrity.

5.3. Post-Sample Collection Actions

1. Store the collected samples in designated storage areas, ensuring they are properly sealed and protected from contamination.
2. For aerosol samples, ensure that the cans are not tampered with or damaged during storage.
3. Document the details of each sample collection, including the time, batch number, sampling point, operator name, and any relevant observations in the In-Process Sampling Log (Annexure-1).
4. Transport the collected samples to the QC lab for analysis as soon as possible to ensure product quality.

5.4. Sample Analysis

1. The QC team is responsible for analyzing the in-process samples to verify compliance with the product specifications, which may include:
   • Fill weight checks
   • Propellant level analysis
   • Spray performance testing
   • Visual inspection for defects or contamination
2. Document the results of all sample analysis in the In-Process Sample Analysis Log (Annexure-2), noting any deviations or non-conformances.
3. If any samples fail to meet the required specifications:
   • Immediately notify the production team to investigate and resolve the issue.
   • Document corrective actions taken in the Corrective Action Log (Annexure-3).

5.5. Calibration and Maintenance of Sampling Equipment

1. Ensure that all equipment used for sample collection, including syringes, sample bottles, and other tools, is calibrated and maintained according to the manufacturer’s specifications and company procedures.
2. Perform routine maintenance on sample collection tools to ensure that they function properly and do not introduce contamination into the samples.
3. Document all calibration and maintenance activities in the Equipment Calibration Log (Annexure-4) and the Equipment Maintenance Log (Annexure-5).

5.6. Documentation and Record-Keeping

1. Document all in-process sampling activities, including the sample ID, test date, collection point, sample volume, operator name, and any observations in the In-Process Sampling Log (Annexure-1).
2. Ensure that all records are reviewed by the QC team to confirm that the samples meet the required specifications and that appropriate actions are taken if any discrepancies are found.
3. Store all records in the document management system, ensuring they are available for future reference and audits.

5.7. Safety and Environmental Considerations

1. Ensure that all personnel involved in sample collection wear appropriate PPE to prevent exposure to aerosols, chemicals, or other hazardous materials.
2. Follow safety guidelines for handling pressurized aerosol cans during sample collection, particularly when collecting samples from filled cans or after crimping.
3. Ensure proper disposal of any waste generated during the sample collection process, including non-conforming cans and any leftover samples, in accordance with safety and environmental regulations.

6. Abbreviations

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

7. Documents

1. In-Process Sampling Log (Annexure-1)
2. In-Process Sample Analysis Log (Annexure-2)
3. Corrective Action Log (Annexure-3)
4. Equipment Calibration Log (Annexure-4)
5. Equipment Maintenance Log (Annexure-5)

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

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: In-Process Sampling Log

Sample ID	Test Date	Collection Point	Sample Volume (mL)	Operator Name	Remarks
SP-12345	06/02/2025	After filling	50 mL	Rajesh Patel	No issues found

Annexure-2: In-Process Sample Analysis Log

Sample ID	Analysis Date	Analysis Type	Result	Operator Name	Remarks
SP-12345	06/02/2025	Fill weight check	Pass	Rajesh Patel	No issues found

Annexure-3: Corrective Action Log

Sample ID	Issue Date	Issue Description	Corrective Action	Operator Name
SP-12346	06/02/2025	Underfilled	Adjusted machine settings	Rajesh Patel

Annexure-4: Equipment Calibration Log

Equipment ID	Calibration Date	Calibration Results	Operator Name	Remarks
SAMPLER-001	06/02/2025	Pass	Rajesh Patel	No adjustments required

Annexure-5: Equipment Maintenance Log

Equipment ID	Maintenance Date	Tasks Performed	Operator Name	Remarks
SAMPLER-001	06/02/2025	Cleaned and calibrated	Rajesh Patel	No issues found

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 in-process sampling procedure	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures