modified processes requiring validation through PPQ at the Gel Manufacturing Department.

3. Responsibilities

• Validation Executive: Drafts and executes PPQ protocol and oversees data collection.
• Production Team: Executes PPQ batches as per defined protocol.
• Quality Control: Conducts in-process and finished product testing.
• Quality Assurance: Reviews PPQ documentation and ensures regulatory compliance.

4. Accountability

Head – Manufacturing

5. Procedure

5.1 Preparation and Planning

1. Develop a PPQ protocol outlining product details, critical parameters, acceptance criteria, and sampling plan.
2. Identify Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs).
3. Pre-approve the protocol from QA and Regulatory Affairs.

5.2 Execution of PPQ Batches

1. Manufacture a minimum of three consecutive commercial-scale batches under routine conditions.
2. Ensure all equipment is qualified, calibrated, and operated as per SOPs.
3. Capture environmental and process data for every critical step (e.g., mixing time, speed, deaeration pressure, filling temperature).

5.3 In-process Controls

1. Conduct in-process checks such as:
   • Appearance, pH, viscosity, weight variation, fill volume
   • Homogeneity and air entrapment check
   • Microbial limits and preservative content

5.4 Finished Product Testing

1. Analyze each batch for assay, degradation products, sterility (if applicable), and packaging integrity.
2. Conduct stability sampling as per long-term and accelerated conditions.

5.5 Documentation and Report

1. Compile all results, raw data, deviations, and corrective actions in a PPQ report.
2. Compare results with acceptance criteria defined in the protocol.
3. Get the final report approved by QA, Regulatory Affairs, and Manufacturing Head.

5.6 Outcome and Next Steps

1. If all three batches meet specifications: Process is validated.
2. If any batch fails: Conduct deviation investigation and repeat PPQ as necessary.

6. Abbreviations

• PPQ: Process Performance Qualification
• CPP: Critical Process Parameter
• CQA: Critical Quality Attribute
• QA: Quality Assurance
• QC: Quality Control

7. Documents

1. PPQ Protocol – Annexure-1
2. PPQ Execution Log – Annexure-2
3. PPQ Final Report – Annexure-3
4. Batch Manufacturing Records

8. References

• FDA Guidance on Process Validation (2011)
• ICH Q8(R2): Pharmaceutical Development
• WHO TRS 1019 Annex 3: Process Validation

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: PPQ Protocol Format

Product Name
Batch Size
Equipment Used
CPPs and CQAs
Acceptance Criteria
Sampling Plan

Annexure-2: PPQ Execution Log

Date	Batch No.	Observation	Performed By	Reviewed By

Annexure-3: PPQ Report Summary

Batch No.	Test	Result	Spec Limit	Status

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
10/06/2022	1.0	Initial version	New SOP	QA Head
02/06/2025	2.0	Expanded scope, included detailed annexures	Annual Review	QA Head