the manufacturing of Active Pharmaceutical Ingredients (APIs). It includes review of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.

3. Responsibilities

• Engineering Department: Prepares the qualification protocol and supporting documentation.
• Validation/Technical Team: Provides technical input, calibration data, and testing criteria.
• QA Department: Reviews, approves, and ensures compliance of qualification protocols with regulatory requirements.

4. Accountability

The Head of Quality Assurance is accountable for ensuring that all qualification protocols are reviewed for adequacy, completeness, regulatory alignment, and risk assessment before execution.

5. Procedure

5.1 Receipt of Qualification Protocol

1. The Engineering/Validation Department shall submit the draft qualification protocol to QA using the Qualification Protocol Submission Form (Annexure-1).
2. QA shall log the receipt in the Qualification Protocol Tracking Register (Annexure-2).

5.2 Review Parameters

1. QA shall review the protocol for the following:
   • Protocol identification number and version
   • Equipment description and user requirement specification (URS)
   • GxP criticality of the equipment
   • Defined acceptance criteria
   • Test procedures and frequency
   • Calibration and maintenance history (if applicable)
   • Risk assessment and impact on product quality
   • Responsibility matrix and training requirement

5.3 Approval Process

1. After satisfactory review, QA shall sign the QA Review and Approval Sheet (Annexure-3).
2. If any deficiencies are found, QA shall return the protocol with comments for revision. All communications shall be tracked via the Protocol Review Comment Sheet (Annexure-4).

5.4 Protocol Contents

1. The qualification protocol must include:
   • Title Page and Table of Contents
   • Objective and Scope
   • Responsibilities
   • Equipment details (Make, Model, Serial No.)
   • Pre-requisites and Safety Measures
   • Qualification Test Procedures and Forms
   • Acceptance Criteria
   • Deviation Handling Procedure
   • Summary Report Template
   • Approval Page with QA, Engineering, and Validation signatures

5.5 Change Control and Revision

1. Any major revision of qualification protocols must be managed through the site change control process.
2. QA shall ensure that the revised protocol references the original document number and includes justification for revision.

5.6 Archival

1. Upon completion and approval of the qualification protocol and summary report, QA shall ensure the documents are archived in the Validation Document Archive Room.
2. Document archival shall be logged in the Qualification Document Archival Register (Annexure-5).

6. Abbreviations

• IQ: Installation Qualification
• OQ: Operational Qualification
• PQ: Performance Qualification
• QA: Quality Assurance
• URS: User Requirement Specification
• GxP: Good x Practice (e.g., GMP, GLP)
• SOP: Standard Operating Procedure

7. Documents

1. Qualification Protocol Submission Form (Annexure-1)
2. Qualification Protocol Tracking Register (Annexure-2)
3. QA Review and Approval Sheet (Annexure-3)
4. Protocol Review Comment Sheet (Annexure-4)
5. Qualification Document Archival Register (Annexure-5)

8. References

• ICH Q9 – Quality Risk Management
• ICH Q7 – GMP for APIs
• EU GMP Annex 15 – Qualification and Validation
• ISPE Baseline Guide Vol. 5 – Commissioning and Qualification

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Qualification Protocol Submission Form

Protocol No.	Equipment	Department	Submitted By	Date
EQP/VAL/2025/001	Fluid Bed Dryer	Engineering	Rajesh Kumar	10/04/2025

Annexure-2: Qualification Protocol Tracking Register

Protocol No.	Equipment	Submission Date	QA Review Date	Status
EQP/VAL/2025/001	Fluid Bed Dryer	10/04/2025	12/04/2025	Approved

Annexure-3: QA Review and Approval Sheet

Reviewed By	Designation	Date	Remarks
Sunita Reddy	QA Executive	12/04/2025	Compliant

Annexure-4: Protocol Review Comment Sheet

Protocol No.	Comment	Suggested By	Resolved On
EQP/VAL/2025/001	Include calibration schedule in pre-requisites	QA	11/04/2025

Annexure-5: Qualification Document Archival Register

Protocol No.	Equipment	Archived On	Storage Location
EQP/VAL/2025/001	Fluid Bed Dryer	13/04/2025	QA Archive Room Shelf B3

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial Release	New SOP	QA Head
14/04/2025	2.0	Added archival and change control handling	Compliance Alignment	QA Head