analyzed and documented.

Validation Team: Responsible for developing and reviewing the cleaning validation protocol, including the sampling plan, and analyzing sampling data.

Regulatory Affairs Team: Ensures that the sampling techniques and cleaning validation processes comply with applicable regulatory standards.

4. Accountability

The Manufacturing Manager is accountable for ensuring that cleaning validation sampling is performed according to this SOP. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Determining Sampling Method

1. Two primary sampling techniques are used for cleaning validation:
   • Rinse Water Sampling: Rinse water is collected after the cleaning process to test for any residues remaining in the equipment.
   • Surface Swabbing: A surface swab is used to collect samples directly from the cleaned surfaces of the filling machine (e.g., nozzles, pumps, tubes) to test for residues.
2. The choice of sampling technique depends on the type of machine, the cleaning procedure used, and the area being cleaned. For certain parts of the filling machine, surface swabbing may be more effective, while rinse water sampling may be appropriate for other areas.
3. The sampling technique must be specified in the cleaning validation protocol, and the sampling method should be consistently applied during each validation run.

5.2. Preparing for Sampling

1. Before collecting samples, ensure that all equipment used for sampling (e.g., swabs, containers, collection vials) is clean, dry, and sterile if necessary.
2. The sampling area should be free from contamination, and proper hygiene and cleanliness procedures must be followed during sample collection to avoid cross-contamination.
3. Each sampling point on the equipment should be clearly identified and recorded in the cleaning validation protocol. These points may include areas where direct product contact occurs, as well as areas that are difficult to clean.
4. Sampling should be conducted immediately after the cleaning process and before the equipment is used for the next production run.

5.3. Collecting Rinse Water Samples

1. Rinse water samples should be collected after the cleaning procedure is complete and the equipment has been rinsed with water or cleaning solution.
2. The following steps should be followed when collecting rinse water samples:
   • Rinse the equipment thoroughly to ensure that any residual cleaning agents or contaminants are removed.
   • Collect the first rinse water in a clean, sterile container that is pre-labeled with the batch number and sampling point.
   • Record the volume of water used for rinsing and ensure that an adequate amount of water is collected for analysis.
   • Label the sample container with relevant information, including the date, time, and equipment cleaned.
3. Once the rinse water sample is collected, it should be sent to the laboratory for analysis to check for any residues, including active ingredients and cleaning agents.

5.4. Collecting Surface Swab Samples

1. Surface swabbing should be performed on all areas of the filling machine that come into direct contact with the product, such as nozzles, filling heads, pumps, and valves.
2. The following steps should be followed when collecting surface swab samples:
   • Using a sterile swab, moisten the swab with a suitable solvent (e.g., water or alcohol) and wipe the surface of the equipment where residues may be present.
   • The swab should be applied to areas that are difficult to access or clean, as well as areas that have direct product contact.
   • The swab should be returned to a clean, sterile container and sealed for analysis.
   • Label the swab container with relevant information, including the sampling location, date, time, and equipment cleaned.
3. The swab samples should be sent to the laboratory for analysis to determine if any residues are present on the surface of the equipment.

5.5. Analyzing Sample Data

1. Once the samples are collected, they should be analyzed for residues, including active ingredients, cleaning agents, and other contaminants that may be left on the equipment.
2. The analysis should be conducted using validated methods, such as High Performance Liquid Chromatography (HPLC) or other appropriate analytical techniques.
3. The results of the analysis should be compared to the predefined acceptance criteria to determine whether the equipment is clean and suitable for the next production run.
4. If the results show that residue levels exceed the acceptable limits, the cleaning process should be reviewed and adjustments made as necessary. Further cleaning and sampling may be required.

5.6. Documenting Sampling and Results

1. All sampling activities should be documented in the Cleaning Validation Report (Annexure-1), including:
   • Sampling technique used (rinse water or surface swab)
   • Sampling points and equipment cleaned
   • Results of the analysis, including residue levels and any deviations from acceptance criteria
   • Corrective actions taken if any issues were identified
2. The final Cleaning Validation Report should be reviewed and approved by the QA team and other relevant departments. Once approved, the report should be stored for future reference and regulatory inspections.

5.7. Revalidation of Sampling Techniques

1. If any changes are made to the cleaning process, equipment, or sampling techniques, the sampling process should be revalidated to ensure its continued effectiveness.
2. Revalidation should include a review of sampling points, sample collection methods, and testing procedures to ensure that they remain appropriate for the revalidated cleaning process.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• SOP: Standard Operating Procedure
• HPLC: High Performance Liquid Chromatography
• CAPA: Corrective and Preventive Action

7. Documents

1. Cleaning Validation Report (Annexure-1)
2. Deviation Log (Annexure-2)

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
• International Council for Harmonisation (ICH) Guidelines

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Cleaning Validation Report

Batch Number	Test Date	Test Parameters	Result	Remarks
Batch-001	10/02/2025	Filling nozzles, pumps	Pass	Residue levels within acceptable limits

Annexure-2: Deviation Log

Deviation ID	Deviation Description	Corrective Action	Assigned To	Status
DEV-12345	Residue above limit	Adjusted cleaning procedure	Rajesh Patel	Completed

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 cleaning validation procedures	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures