compliance.

Quality Control: Conducts analytical testing of in-process and finished product samples.

4. Accountability

The Head of Manufacturing and Head of Quality Assurance are accountable for ensuring the successful execution and documentation of process validation activities.

5. Procedure

5.1 Preparation and Approval of Protocol

1. The Validation Officer prepares a protocol including objectives, scope, acceptance criteria, sampling plan, critical parameters, and statistical analysis methods.
2. Protocol must be reviewed by Production, QC, and approved by QA before execution.

5.2 Execution of Validation Batches

1. Three consecutive batches shall be manufactured under normal operating conditions.
2. All critical process parameters (CPPs) and critical quality attributes (CQAs) must be controlled and recorded.
3. In-process controls like pH, viscosity, homogeneity, and temperature must be sampled and tested at defined stages.

5.3 Sampling and Testing

1. Samples shall be collected from defined locations (start, middle, end of batch, different containers).
2. QC to perform analysis for assay, microbial load, preservative content, and physicochemical properties.
3. Compare results with specifications; any deviation should be documented and investigated.

5.4 Data Review and Statistical Evaluation

1. Collate data from all three batches in tabulated format.
2. Perform statistical evaluation (mean, SD, RSD, trend analysis).
3. Ensure variability is within acceptable limits and process is reproducible.

5.5 Report Preparation and Approval

1. The Validation Officer prepares the final report summarizing all data, observations, and deviations.
2. QA reviews the report for completeness and compliance before final approval.
3. The validated process is transferred to routine production post-approval.

6. Abbreviations

• CQA: Critical Quality Attribute
• CPP: Critical Process Parameter
• QA: Quality Assurance
• QC: Quality Control
• SOP: Standard Operating Procedure

7. Documents

1. Process Validation Protocol – Annexure-1
2. Batch Manufacturing Records – Annexure-2
3. Process Validation Report – Annexure-3

8. References

• ICH Q8(R2): Pharmaceutical Development
• ICH Q9: Quality Risk Management
• EU GMP Annex 15: Qualification and Validation
• FDA Process Validation Guidance (2011)

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Jr. Production Chemist	QA Executive	Head – Manufacturing
Department	Gel Manufacturing	Quality Assurance	Manufacturing

11. Annexures

Annexure-1: Process Validation Protocol Format

Product Name
Batch Nos.
Objective
Parameters to Validate
Acceptance Criteria
Sampling Points
Analytical Methods
Execution Dates

Annexure-2: Batch Manufacturing Record Summary Format

Parameter	Batch 1	Batch 2	Batch 3	Specification
pH
Viscosity
Homogeneity

Annexure-3: Process Validation Report Format

Report No.
Summary of Batches
Observations
Deviation (if any)
Conclusion
QA Comments

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
24/04/2022	1.0	Initial release	New SOP	QA Head
09/06/2025	2.0	Updated process parameters and added statistical analysis section	Annual revision	QA Head