manufacturing processes, including but not limited to mixers, homogenizers, pH meters, and filling equipment.

3. Responsibilities

• Engineering Department: Preparation and execution of qualification protocols.
• Quality Assurance (QA): Approval of protocols, monitoring qualification activities, and review of final reports.
• Gel Manufacturing Personnel: Provide support and relevant operational data during qualification.
• Validation Team: Coordinates qualification activities and maintains documentation.

4. Accountability

QA Head is accountable for final review and approval of qualification documentation ensuring compliance with GMP guidelines.

5. Procedure

5.1 Qualification Types

• DQ (Design Qualification): Verifies design meets user requirements.
• IQ (Installation Qualification): Confirms installation per manufacturer specs.
• OQ (Operational Qualification): Ensures equipment functions under expected conditions.
• PQ (Performance Qualification): Verifies consistent performance during routine use.

5.2 Initiation and Approval

1. User Requirement Specification (URS) is prepared by manufacturing in coordination with QA.
2. Based on URS and equipment specification, Engineering drafts qualification protocols.
3. QA reviews and approves the protocols before execution.

5.3 Execution of Qualification

1. Engineering executes IQ and OQ in presence of QA.
2. PQ is performed during trial batches or test runs simulating actual production conditions.
3. Any deviations are documented and evaluated for impact.

5.4 Documentation and Final Report

1. All test results are recorded in qualification documents.
2. QA compiles and reviews data to prepare the final summary report.
3. Qualified status is granted only after all stages are completed successfully.

5.5 Re-Qualification

1. Re-qualification is required in the following cases:
   • After major repairs or modifications
   • Relocation of equipment
   • At defined intervals as per validation master plan (VMP)

6. Abbreviations

• DQ: Design Qualification
• IQ: Installation Qualification
• OQ: Operational Qualification
• PQ: Performance Qualification
• URS: User Requirement Specification
• VMP: Validation Master Plan

7. Documents

1. User Requirement Specification – Annexure-1
2. IQ Protocol – Annexure-2
3. OQ Protocol – Annexure-3
4. PQ Protocol – Annexure-4
5. Qualification Summary Report – Annexure-5

8. References

• ICH Q9: Quality Risk Management
• WHO TRS 937: Validation Guidelines
• 21 CFR Part 211

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: User Requirement Specification (URS)

Equipment Name
Intended Use
Key Functional Requirements
Utilities Required
Environmental Requirements

Annexure-2: Installation Qualification Protocol (IQ)

Equipment Tag No.
Installation Checks	Mounting, alignment, utility connections
Document Verification	User Manual, Calibration Certificate
Compliance Remarks

Annexure-3: Operational Qualification Protocol (OQ)

Function	Expected Outcome	Actual Outcome	Status (Pass/Fail)
Speed Control	Variable speed from 100–500 rpm
Temperature Control	Maintain 25–30°C ±2°C

Annexure-4: Performance Qualification Protocol (PQ)

Batch No.
Product Name
Yield (%)
Viscosity Range
Remarks

Annexure-5: Qualification Summary Report

Equipment
Qualification Type	DQ / IQ / OQ / PQ
Findings
Conclusion
Final Approval By QA

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
01/06/2022	1.0	Initial release	New SOP	QA Head
02/06/2025	2.0	Updated annexures and PQ details	Annual review	QA Head