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OPERATIONAL QUALIFICATION (OQ) PROTOCOL FOR PHARMA EQUIPMENT

PHARMA EQUIPMENT NAME S. NO. SUPPLIER ASSET NO. DVMP REFERENCE NO. OQ REFERENCE NO.
S. No 1 2 3 4 5 6 7 8 Responsibility & Title Prepared By Engineer / IT Staff Reviewed By Validation Supervisor Approved By Production Engineering Manager Approved By Facilities Engineering Manager Approved By IT Manager Approved By User Department Head Approved By Compliance Manager Authorized By QA-Manager
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: : : : : :

<Provide Pharma Equipment Name> <Provide S. No.> <Provide Supplier Name> <Provide Asset No. assigned by FED> <Provide Reference No. assigned by Validation> <Provide OQ Reference No. assigned by Validation section>
Name Signature Date

OPERATIONAL QUALIFICATION PROTOCOL

PHARMA EQUIPMENT NAME <Provide > OQ REFERENCE <Provide>>

S. No 1.0 2.0 2.1 2.2 2.3 2.4 3.0 4.0 4.1 4.2 4.2.1 4.2.2 4.2.3 5.0 Purpose OQ Test and Acceptance Criteria OQ Pre-Requisite OQ Test-Verification of SOPs

Description

Page No.

OQ Test-Challenge Test for Functionality OQ Test-Identification of Additional Training Handling of Deviation Execution of OQ OQ Validation Team OQ Data Sheet Observation & Conclusion for OQ Test Details of Approved Deviation Outstanding Action Report Operational Qualification Report

1.0

PURPOSE
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OPERATIONAL QUALIFICATION PROTOCOL

PHARMA EQUIPMENT NAME <Provide > OQ REFERENCE <Provide>>

This Operational Qualification Protocol ensures & covers: 2.0 2.1 The Pharma Equipment is functioning according to Approved Document (FS or Pharma Equipment Matrix). Pharma Equipment meets the Specification (URS). All functionalities are challenged and proofed to satisfactory. All drafted SOPs identified by IQ are verified for functionality and parameters. Training is completed according as identified by IQ. All OQ observations are recorded according to requirement. Approval of Further Qualification or intended use.

OQ TEST AND ACCEPTANCE CRITERIA OQ PRE-REQUISITE Description

IQ Draft SOP <List down all SOPs identified by IQ> Training <List down all Trainee name identified by IQ> Equipment Logbook <List down all logbook name identified by SOP>

S. No
2.1.1 2.1.2 2.1.3 2.1.4

Reference No.
<Provide> <Provide> <Provide> <Not Applicable>

Acceptance Criteria
<Approved > <Available> <Training Record Should Be Available> <Logbook should be in place>

2.2

OQ TEST-VERIFICATION OF SOPs
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OPERATIONAL QUALIFICATION PROTOCOL

PHARMA EQUIPMENT NAME <Provide > OQ REFERENCE <Provide>>

2.2.1. <NAME OF OPERATION / CLEANING SOP> Purpose <To verify the contents and functionality of SOP with Pharma equipment> Required Materials for Test <Draft SOP> Test Procedure and Acceptance Criteria Test Step No
<S. No.> <S. No.> <S. No.> <S. No.>

Test Procedure
<SOP Procedure to be verified> <Required IPC Tests are to be verified where applicable> <The contents under SOP-Requirement title is to be verified> <The contents under Records title is to be verified>

Reference from URS / FS / PEM

<Not Applicable> <Not Applicable> <Not Applicable> <Not Applicable>

Acceptance Criteria
<SOP Functionality is verified and corrected wherever required> <IPC Test Procedure & Acceptance criteria is verified and corrected wherever required> <Requirement section is verified and corrected wherever required> <Record section is verified and corrected wherever required>

2.2.2. <NAME OF MAINTENANCE SOP> Purpose <To verify the contents and maintenance of SOP with Pharma equipment supplier or manual> Required Materials for Test <Draft SOP> Test Procedure and Acceptance Criteria Test Step No
<S. No.> <S. No.> <S. No.>

Test Procedure
<SOP Procedure to be verified with Manual or Pharma Equipment Supplier> <The contents under SOP-Requirement title is verified> <The contents under Records title is verified>

Reference from URS / FS / PEM

<Not Applicable> <Not Applicable> <Not Applicable>

Acceptance Criteria
<SOP Procedure is verified and corrected wherever required> <Requirement section is verified and corrected wherever required> <Record section is verified and corrected wherever required>

2.3

OQ TEST-CHALLENGE TEST FOR FUNCTIONALITY

2.3.1. <NAME OF TEST>

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OPERATIONAL QUALIFICATION PROTOCOL

PHARMA EQUIPMENT NAME <Provide > OQ REFERENCE <Provide>>

Purpose <Provide purpose of this Test> Required Materials for Test <Provide all required materials for execution of this Test> Test Procedure and Acceptance Criteria Test Step No
<S. No.>

Test Procedure
<Provide Test Step Procedure>

Reference from URS / FS / PEM

<Provide or NA if Not Applicable>

Acceptance Criteria
<Provide Acceptance Criteria for this Step or NA if Not Applicable>>

Note: To verify the above test, wherever applicable the relevant draft SOP shall be used.

2.4

OQ TEST-IDENTIFICATION OF ADDITIONAL TRAINING

While executing the OQ Test with draft SOPs, Identify any additional trainings are required (apart from previous training) for following operations and Train the relevant staff accordingly. S. No
2.4.1 2.4.2 2.4.3 2.4.4

SOP
Operation & Cleaning Maintenance Hardware & Software Calibration

Acceptance Criteria
<Additional Training is required and Trained accordingly or NA if Not Applicable> <Additional Training is required and Trained accordingly or NA if Not Applicable> <Additional Training is required and Trained accordingly or NA if Not Applicable> <Additional Training is required and Trained accordingly or NA if Not Applicable>

3.0

HANDLING OF DEVIATION If any deviation observed while verifying the Installation according to above requirements must be documented and assessed through Deviation and Incident Handling Procedure, and decision will be taken accordingly. The details of approved deviation will be recorded in S. No. 4.2.2

4.0 4.1

EXECUTION OF OQ OQ VALIDATION TEAM

The following identified representative will execute the Operational Qualification:

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OPERATIONAL QUALIFICATION PROTOCOL

PHARMA EQUIPMENT NAME <Provide > OQ REFERENCE <Provide>>

Department Production Engineerin g Facilities Engineerin g IT User Department Quality Assurance

Representative Name
<To be assigned by Department Head> <To be assigned by Department Head> <To be assigned by Department Head> <To be assigned by Department Head> <To be assigned by Department Head>

Responsibility to check and record the observation in OQ checklist

<Provide OQ Test and acceptance Criteria S. No> <Provide OQ Test and acceptance Criteria S. No> <Provide OQ Test and acceptance Criteria S. No> <Provide OQ Test and acceptance Criteria S. No> <Provide OQ Test and acceptance Criteria S. No>

Representative Signature

Date

As per the responsibility assigned, the representative must test the Pharma Equipment according to above tests and record the observation on OQ Data Sheet (S. No. 4.2).

4.2

OQ DATA SHEET

4.2.1 OBSERVATION AND CONCLUSION FOR OQ TEST

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OPERATIONAL QUALIFICATION PROTOCOL

PHARMA EQUIPMENT NAME <Provide > OQ REFERENCE <Provide>>

OQ S. No

Test Observation

Conclusion (Pass / Fail / Pass with Comments)

Comments

Sign with Date

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OPERATIONAL QUALIFICATION PROTOCOL

PHARMA EQUIPMENT NAME <Provide > OQ REFERENCE <Provide>>

S. No

Test Observation

Conclusion (Pass / Fail / Pass with Comments)

Comments

Sign with Date

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OPERATIONAL QUALIFICATION PROTOCOL

PHARMA EQUIPMENT NAME <Provide > OQ REFERENCE <Provide>>

S. No

Test Observation

Conclusion (Pass / Fail / Pass with Comments)

Comments

Sign with Date

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OPERATIONAL QUALIFICATION PROTOCOL

PHARMA EQUIPMENT NAME <Provide > OQ REFERENCE <Provide>>

4.2.2 DETAILS OF APPROVED DEVIATION

Deviation Details Deviation Report No. Status of Deviation Signature & Date

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OPERATIONAL QUALIFICATION PROTOCOL

PHARMA EQUIPMENT NAME <Provide > OQ REFERENCE <Provide>>

4.2.3 OUTSTANDING ACTION REPORT S. No Outstanding Action Agreed Corrective Action Agreed Completion Date Relevant Dept Head Signature Date

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OPERATIONAL QUALIFICATION PROTOCOL

PHARMA EQUIPMENT NAME <Provide > OQ REFERENCE <Provide>>

S. No

Validation Supervisor Assessment

Signature

Date

QA Manager Decision

Signature Out Standing Action Completion Report Outstanding Action S. No Action Taken

Date

Status (Accepted / Not Accepted)

Validation Supervisor Sign with date

5.0

OPERATIONAL QUALIFICATION REPORT Recommendation / Comments

Signature

Date

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OPERATIONAL QUALIFICATION PROTOCOL

PHARMA EQUIPMENT NAME <Provide > OQ REFERENCE <Provide>>

The Operational Qualification (OQ) of <Pharma Equipment Name> is performed in accordance with the procedures and standards. The Operational Qualification confirms the <Pharma Equipment Name> complies / complies with recommendation / does not comply to the acceptance criteria stated in this protocol. S. No
1. 2. 3. 4. 5. 6. 7.

Responsibility
Reviewed By Approved By Approved By Approved By Approved By Approved By Authorized By

Name & Title

Validation Supervisor Facilities Engineering Manager Production Engineering Manager IT Department Head User Department Head Compliance Manager Quality Assurance Manager

Signature

Date

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