adheres to regulatory guidelines such as ICH, USP, and FDA requirements.

4. Accountability

The QA Manager is accountable for ensuring that QA oversight is integrated into every stage of the process validation. The Process Validation Team is responsible for executing the validation protocols and collaborating with QA for documentation and compliance verification.

5. Procedure

5.1 Preparation for Process Validation

1. Ensure that a formal process validation protocol is developed, outlining the process steps, validation parameters, equipment requirements, and acceptance criteria (Annexure-1).
2. QA must review and approve the process validation protocol before any validation activities begin.
3. Ensure that all necessary equipment, raw materials, and personnel are available and ready for the process validation study.
4. Confirm that the appropriate stability study and batch records are in place for the validation batches to be used in the study (Annexure-2).

5.2 QA Oversight During Execution of Process Validation

1. During process validation execution, QA must oversee the process to ensure that all steps are followed as per the validation protocol.
2. Monitor the execution of the process validation study and ensure that all equipment is calibrated and working properly.
3. Verify that the critical process parameters, such as temperature, pressure, and mixing speed, are within the validated ranges during each batch of the study.
4. Ensure that sampling is done at appropriate time points and that samples are sent to the QC laboratory for analysis (Annexure-3).
5. Document any deviations observed during the execution of the process and ensure corrective actions are taken immediately (Annexure-4).

5.3 Data Collection and Review

1. QA must ensure that all process validation data is collected, recorded, and analyzed according to the established protocol.
2. Ensure that the data reflects the actual process conditions and that any deviations are properly investigated and documented.
3. Once the validation batches are completed, review the collected data for completeness and accuracy. Confirm that all test results meet the predefined acceptance criteria (Annexure-5).
4. If any data points fall outside of the acceptable limits, work with the Process Validation Team to assess whether the batch needs to be reprocessed or discarded.

5.4 Final Approval of Process Validation

1. Once the validation data has been reviewed, QA must give the final approval for the process validation report (Annexure-6).
2. If the process validation is successful and all criteria are met, QA will approve the process and release it for routine production use.
3. If the validation fails, QA and the Process Validation Team will work together to identify corrective actions and perform additional validation runs if necessary.
4. Ensure that the final validation report, including all test results, deviations, and corrective actions, is signed off by the QA Manager.

5.5 Documentation and Record Keeping

1. Ensure that all process validation records, including protocols, data, reports, and deviation logs, are properly documented and archived according to regulatory requirements.
2. Ensure that all records are signed, dated, and stored in a secure and accessible location for future audits and inspections (Annexure-7).
3. Review the process validation records periodically to ensure compliance with the original protocol and regulatory guidelines.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• QC: Quality Control
• CAPA: Corrective and Preventive Action
• FDA: Food and Drug Administration
• ICH: International Council for Harmonisation
• USP: United States Pharmacopeia

7. Documents

1. Process Validation Protocol (Annexure-1)
2. Stability Study and Batch Records (Annexure-2)
3. Sampling Log (Annexure-3)
4. Deviation Report (Annexure-4)
5. Process Validation Report (Annexure-5)
6. Final Validation Approval (Annexure-6)
7. Process Validation Records Archive (Annexure-7)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
• ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
• USP <1225> – Validation of Analytical Methods

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Process Validation Protocol

Batch Number	Validation Steps	Acceptance Criteria	Test Method
Batch-12345	Process Step 1, Process Step 2	Yield > 95%	Dissolution, Assay

Annexure-2: Stability and Batch Records

Batch Number	Test Parameter	Test Results	Storage Conditions
Batch-12345	Assay	99.8%	25°C ± 2°C, 60% RH

Annexure-3: Sampling Log

Sample ID	Sample Date	Sampled By	Test Method
Sample-123	01/03/2026	John Doe	Dissolution

Annexure-4: Deviation Report

Deviation ID	Deviation Description	Root Cause	Corrective Action
DEV-001	Deviation in temperature	Equipment malfunction	Recalibrate equipment

Annexure-5: Process Validation Report

Batch Number	Validation Results	Approval Status
Batch-12345	Pass	Approved

Annexure-6: Final Validation Approval

Approval ID	Approved By	Approval Date
VAL-001	Jane Smith	01/04/2026

Annexure-7: Process Validation Records Archive

Document	File Location	Retention Period
Process Validation Report	Document Archive A	5 years

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP Creation	QA Head
01/02/2025	2.0	Updated process validation protocol	Added new validation parameters	QA Head