providing process-related information to ensure validation runs are properly documented.

Regulatory Affairs Team: Ensures that validation data is compiled in accordance with applicable regulatory standards and guidelines, and supports the preparation for regulatory submissions or audits.

4. Accountability

The Manufacturing Manager is accountable for ensuring that validation data is properly documented and reviewed according to this SOP. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Collecting Validation Data

1. Validation data should be collected during each stage of the validation process. The following types of data should be recorded:
   • Process parameters (e.g., filling speed, pressure, temperature)
   • Quality attributes (e.g., appearance, spray rate, chemical composition)
   • Equipment performance data (e.g., calibration results, machine settings)
   • Environmental conditions (e.g., temperature, humidity in the manufacturing area)
   • Deviation reports (if applicable)
2. The data should be recorded in real-time during the validation process to ensure accuracy. This can be done manually or using automated data collection systems.
3. Data should be recorded in the Validation Batch Record (Annexure-1) or any other relevant validation documentation.

5.2. Documenting Validation Data

1. Validation data should be documented in a clear and organized manner. The following documentation is required:
   • Validation Batch Record: This record should contain all data collected during the validation process, including process parameters, quality control results, and equipment performance data. It should also include any deviations or non-conformities and corrective actions taken (Annexure-1).
   • Process Monitoring Logs: These logs should document the monitoring of critical process parameters (CPPs) during the validation process.
   • Deviation Log: Any deviations from the established protocols should be documented, including the cause of the deviation and corrective actions (Annexure-2).
2. The documentation must be signed by the operator performing the validation and reviewed by the QA team to ensure accuracy and completeness.

5.3. Reviewing Validation Data

1. Once the validation data has been collected and documented, the QA team should review the data to verify the following:
   • All critical parameters have been monitored and recorded according to the validation protocol.
   • The data complies with predefined acceptance criteria.
   • Any deviations from the protocol have been appropriately documented and corrected.
   • Corrective actions taken in response to deviations have been effective and are properly documented.
2. The QA team should also evaluate whether the data supports the conclusion that the process or equipment is capable of consistently producing a product that meets specifications.
3. If the data review reveals any gaps or issues, the QA team should request further investigations or re-validation, as needed, and ensure that all corrective actions are implemented.

5.4. Reporting Validation Data

1. Once the data review is complete, the final validation report should be prepared. The validation report should summarize the following:
   • The purpose and scope of the validation
   • The validation protocol and acceptance criteria
   • All data collected during the validation process
   • Results of the review of the data and compliance with acceptance criteria
   • Any deviations observed, along with corrective actions taken
   • Conclusions regarding the validation outcome
2. The final validation report should be signed and approved by the QA team and relevant department heads.
3. The report should be stored in the appropriate location (electronic or physical) for future reference and regulatory audits.

5.5. Retaining Validation Data

1. Validation data and reports must be retained for a minimum of 3 years or as required by regulatory guidelines. This includes:
   • All batch records and monitoring logs
   • Deviation logs and corrective action documentation
   • Final validation reports
2. Validation data should be stored in a secure and organized manner, either electronically or in paper format, depending on the company’s record-keeping system.
3. Access to validation data should be restricted to authorized personnel, and data should be readily available for internal audits, regulatory inspections, or process reviews.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• SOP: Standard Operating Procedure
• CPP: Critical Process Parameter
• CFR: Code of Federal Regulations
• OQ: Operational Qualification
• PQ: Performance Qualification

7. Documents

1. Validation Batch Record (Annexure-1)
2. Deviation Log (Annexure-2)
3. Validation Report (Annexure-3)

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: Validation Batch Record

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

Annexure-2: Deviation Log

Deviation ID	Deviation Description	Corrective Action	Responsible Person	Status
DEV-12345	Filling speed deviation	Adjusted machine settings	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 procedures	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures