SOP for Qualifications Protocol (IQ, OQ & PQ)

Category: Pharma SOPs,QA SOPs,Qualification,Validation
written by Abdus Sobhan Salim | January 11, 2025
SOP for qualifications protocol
Learn how to write SOP for qualifications protocol (IQ, OQ & PQ) to ensure compliance, performance, and safety in pharmaceutical equipment qualification processes.

1. PURPOSE

To describes procedure for the approval of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols to ensure compliance with regulatory guidelines and internal quality standards.

2. SCOPE

This SOP applicable to all IQ, OQ, and PQ protocols developed for pharmaceutical equipment, instruments, and systems within this pharmaceutical.

3. RESPONSIBILITIES

3.1 Protocol initiator is responsible to prepare the IQ, OQ, and PQ protocols as per regulatory requirements and company standards. Ensure all necessary technical details, validation steps, and acceptance criteria are included.

3.2 Quality Assurance personnel are responsible to review protocols for completeness, accuracy, and compliance with regulatory requirements. Verify that protocols align with approved validation master plans.

3.3 User department is responsible to provide input regarding operational and performance requirements. Review protocols to ensure they meet user needs.

3.4 Engineering department is responsible to review installation and operational requirements for technical feasibility.

3.5 Validation team is responsible to collaborate with protocol developers to ensure technical and validation accuracy.

3.6 Head of the Quality Assurance is responsible for final approval of protocols to ensure readiness for execution.

4. ACCOUNTABILITY

Head of the Quality Assurance Department

5. ASSOCIATED DOCUMENTS / REFERENCES

5.1 Validation Master Plan (VMP).

6. PRECAUTIONS

Nil

7. PROCEDURE

7.1 PREPARATION  

7.1.1 Identify IQ, OQ & PQ protocols to be prepared.

7.1.2 Nominate qualified and competent individuals.

7.1.3 Maintain a protocol tracking register log book (Annex-1).

7.1.4 In case of system with simple construction and few functions combine IQ & OQ or OQ & PQ tests.

7.1.5 Write stepwise the methods to be used.

7.1.6 Describe how results are to be documented and analyzed.

7.1.7 Add following pages with all IQ/OQ/PQ protocols whether supplied by supplier or prepared in this Pharmaceutical.

7.1.8 Protocol originator or developer draft IQ, OQ, and PQ protocols using the approved template.

Include the following key elements: (but is not limited to).

-Title Page (Name / Reference No. / Approvals)

-Objective

-Scope

-System Description

-Precaution/ Safety

-Responsibility

-Data collection & entry

-Associated document

-Pre-qualification history 

-Acceptance Criteria

-Test Procedures & checks

-Out of Specification results

-Additional tests, if required

7.1.9 Write (if to be prepared) IQ protocols of a system to include (but is not limited to) with following qualification activities:

– Verification of design

– Adherence to installation drawing

– Verification of Utilities

– Verification for calibration

– Verification of Testing

– Verification of Vendor Manual

– Verification of Spares List

– Equipment Data Sheet

– Room Data Sheet

– Safety Data Sheet

7.1.10 Write OQ protocols for following (but is not limited to) qualification activities:

– Verification of record of test instrumentation

– Local Control Panel Checkout

– Verification of alarms & interlocks

– Verification of specific functionality across operating range

7.1.11 Write PQ protocols for following (but are not limited to) qualification activities

– Check for completion of all IQ /OQ document.

– Check for SOP’s.

– Check for approval of used raw materials for QC specifications.

– Identification, monitoring & documentation for actual operating range.

– Demonstration of critical parameters identified at OQ stage.

– Demonstration of system consistency for producing a product of predetermined quality.

– Compliance of end product with pre-determined acceptance criteria. 

7.1.12 Print Name, Designation and sign for prepared by in specified space of protocol in each page having data entry.

7.2 Technical Review

7.2.1 The draft protocol is submitted to the User Department and Engineering Department for technical review.

7.2.2 Review comments are documented and addressed by the Protocol Developer.

7.2.3 Following preparation or upon receiving of protocols from supplier send the protocol to Head of Department of user of protocol.

7.2.4 Review the written protocols for all of the contents and activities.

7.2.5 Propose for additional IQ/ OQ/PQ test, if required.

7.2.6 Propose to amend any step, if required.

7.2.7 Send the protocol to protocol document originator for modification.

7.2.8 Following modification, review the protocol again.

7.2.9 Print name, designation and sign for reviewed by, if satisfactorily prepared.

7.3 QA Review and Approval

7.3.1 Submit the reviewed protocol to Head of Quality Assurance.

7.3.2 Check the reviewed protocol for compliance with the site GMP and regulatory requirements.

7.3.3 Send the protocol to Document Originator for modification, if Head of Quality Assurance is not satisfied with preparation or review.

7.3.4 Includes all necessary acceptance criteria and test details.

7.3.5 QA provides feedback and requests revisions if needed.

7.3.6 The final version of the protocol is circulated for approval signatures from:

– User Department Head

– Engineering Head

– Validation Manager

– QA Head

7.3.7 Approving authorities ensure the protocol is complete, clear, and executable.

7.3.8 Once all signatures are obtained, the protocol is approved for execution.

7.3.9 QA Head Sign for approval, if the protocol is satisfactorily prepared & reviewed.

7.3.10 The approved protocol is assigned a unique identification number and register in log book.

7.3.11 Original documents are retained by QA, and controlled copies are distributed to relevant departments for working.

Related Document:

(IQ, OQ & PQ) Qualifications of Injectable Tank

8. DEFINITIONS/ABBREVIATIONS

8.1 Qualification: The documented process of verifying that equipment operates correctly and consistently within specified limits.

8.2 Installation Qualification (IQ): Verification that equipment or systems are installed as per manufacturer’s specifications and design requirements.

8.3 Operational Qualification (OQ): Confirmation that equipment or systems operate within specified limits.

8.4 Performance Qualification (PQ): Validation that equipment or systems consistently perform according to intended use under normal operating conditions

8.5 cGMP: Current Good Manufacturing Practice

8.6 SOP: Standard Operating Procedure

8.7 QA: Quality Assurance

9. ANNEXES

9.1 Annex-1: Protocol Register Log Book

Protocol Number

 Protocol Title Originator Revision Protocol Approved Start Execution Present Status End Execution Provisional Approval Actions Complete Final Approval
                     
                     
                     
                     
                     
                     
                     
                     
                     
                     
                     

9.2 Annex-2: Approval Form Template

REVIEW AND APPROVAL

(Front Page)

IQ/OQ PROTOCOL FOR ………………………………………….………………….………………

QUALIFICATION PROTOCOL REFERENCE NO………………………………………….

  1. This IQ/OQ Protocol has been prepared by Supplier / X Pharma

(Name of Supplier, or X Pharma staff) ……………………………………………………………

  • This IQ/OQ Protocol has been reviewed by

            Name: ……………………………………………..       Signature :………………………………………

            Designation:………………………………………       Date :……………………………………………..

  • The following tests were not included in the Protocol and have been added as additional IQ/OQ testing.

(List)  ……………………………………………………….

………………………………………………………………..

………………………………………………………………..

………………………………………………………………..

            Name: ……………………………………………..       Signature :………………………………………

            Designation:………………………………………       Date :……………………………………………..

4.         This IQ/OQ Protocol, together with the additional tests included (If applicable), is now approved for use.

            Name: ……………………………………………..       Signature :………………………………………

            Designation:………………………………………       Date :……………………………………………..

FINAL APPROVAL

(Final Page)

IQ/OQ PROTOCOL FOR……………………………………………………………………………

QUALITY PROTOCOL REFERENCE NO………………………………………….

  1. The tests in this IQ/OQ Protocol have been carried out in accordance with the requirements of the Protocol in conjunction with SOP/QA/00X

There are ………………………. Non Compliance identified and these are listed on Non–Compliance Report form.

            Name: …………………………………………..          Signature :………………………………….. 

            Designation:……………………………………..        Date :………………………………………………

  • Remedial actions, to rectify the identified Non-Compliance, have been agreed, responsibility assigned and target completion dates set (if applicable)

            Name: ……………………………………………..       Signature :………………………………………

            Designation:………………………………………       Date :……………………………………………..

  • The testing and remedial actions, including retesting have been successfully carried out and the IQ/OQ is now satisfactorily completed.

            Name: ……………………………………………..       Signature :……………………………………….

            Designation:………………………………………       Date :……………………………………………..

            Name: …………………………………………..          Signature :…………………………………..

            Designation:……………………………………..        Date :……………………………………………

9.3 Annex-3: Non-Compliance Report

NON-COMPLIANCE REPORT

Ref. section Non-compliance details Category Corrective action
Activity Responsibility Completion date Completion approval
Target Actual Signature Date
                 
                 
                 
                 
                 
                 
                 
                 
                 
                 
                 
                 

10. REVISION HISTORY

Version Date Description of Change Reviewed By Approved By
1.0