monitoring requirements, and ensuring that validation batches are documented properly.

Regulatory Affairs Team: Ensures that validation activities comply with applicable regulatory standards and that the final documentation meets regulatory requirements.

4. Accountability

The Manufacturing Manager is accountable for ensuring that the monitoring and documentation of validation batches are conducted according to this SOP. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Monitoring Validation Batches

1. During the validation process, the following process parameters must be monitored and recorded for each validation batch:
   • Critical process parameters (e.g., filling volume, pressure, temperature, mixing speed)
   • Material usage (e.g., raw materials, propellants)
   • Equipment settings and performance (e.g., machine settings, equipment calibration)
   • Product quality parameters (e.g., spray rate, appearance, pH, chemical composition)
2. Monitoring of parameters should be carried out according to the validation protocol and in accordance with the defined acceptance criteria. Parameters should be continuously or periodically checked depending on the specific process step and the nature of the parameter.
3. Deviations from the specified process parameters should be immediately documented and corrective actions should be implemented as per the Corrective Action Log (Annexure-1).

5.2. Documentation of Monitoring Results

1. All data collected during the monitoring of the validation batch should be accurately recorded in the Validation Batch Record (Annexure-2).
2. The following information must be included in the Validation Batch Record:
   • Batch identification and description
   • List of monitored parameters and acceptance criteria
   • Recorded values for each monitored parameter
   • Time and date of monitoring
   • Operator or system ID responsible for monitoring
   • Any deviations from acceptance criteria and corrective actions taken
3. The Validation Batch Record must be signed by the operator who performed the monitoring and reviewed by the QA team.

5.3. Reviewing and Approving Validation Batch Documentation

1. Once the validation batch is completed, the batch records should be reviewed by the QA team for accuracy and completeness. The QA team should verify that all monitored parameters are within the acceptable range and that any deviations have been appropriately addressed and documented.
2. If any issues or deviations were noted during the batch production, the QA team should ensure that corrective actions were taken and that the product meets all quality specifications.
3. The final validation batch documentation should be approved by the QA Manager, and the results should be used to determine whether the manufacturing process is capable of consistently producing products that meet predefined specifications.

5.4. Corrective and Preventive Actions (CAPA)

1. If any deviations or non-conformities are observed during the monitoring of validation batches, corrective actions must be implemented. These actions should include:
   • Identifying the root cause of the deviation
   • Taking immediate corrective action to address the issue
   • Implementing preventive actions to prevent recurrence of the deviation
2. All corrective and preventive actions should be documented in the Corrective Action Log (Annexure-1). The actions must be reviewed and approved by the QA team.
3. Revalidation may be required if the deviations cannot be addressed or if they affect the overall product quality.

5.5. Finalizing and Storing Documentation

1. Once the monitoring and documentation of the validation batch are complete, the final batch records should be compiled and stored in the appropriate format (electronic or paper) as per company policy.
2. The finalized batch records should be retained for a minimum of 3 years or as required by regulatory guidelines. They must be available for review during internal audits or regulatory inspections.
3. Finalized documentation should be reviewed for completeness and accuracy before submission for final approval by the QA team.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• SOP: Standard Operating Procedure
• CAPA: Corrective and Preventive Action
• CFR: Code of Federal Regulations
• OQ: Operational Qualification
• PQ: Performance Qualification

7. Documents

1. Validation Batch Record (Annexure-2)
2. Corrective Action Log (Annexure-1)

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: Corrective Action Log

Action ID	Action Description	Assigned To	Completion Date	Remarks
ACT-12345	Recalibrated filling system	Rajesh Patel	18/02/2025	Resolved accuracy issue

Annexure-2: Validation Batch Record

Batch Number	Test Date	Parameters Tested	Test Results	Operator Name
Batch-001	10/02/2025	Filling volume, spray rate, appearance	Pass	Rajesh Patel

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