IOPQ Template for Medical Devices Sample

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INSTALLATION, OPERATIONAL AND PERFORMANCE VALIDATION PROTOCOL FOR [NAME HERE]

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Protocol Approval

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Document Title: (further description here)

Print Name

Signature

Date

Print Name

Signature

Date

Production Engineering R&D Regulatory Affairs Quality Assurance

Executionl Approval Production Engineering R&D Regulatory Affairs Quality Assurance

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VALIDATION PROTOCOL Your Logo

Document Title: (describe here)

Introduction Add an Introduction of the Validation Here

Brief System Description and IOPQ Rationale [Describe the System and add a rationale for using the IOPQ approach] All systems shall be challenged in this protocol. Therefore it is imperative that checks are thoroughly documented according cGMP recommendations.

All testing will be performed retrospectively, prospectively, concurrently (delete as appropriate), and all tests will be in accordance with Pharmi Med “Validation Policy – Validation Master Plan.

Scope This protocol covers the Installation, Operational and Performance Qualification (Combined) for the [Name Process Here]. The scope of this document is therefore limited to the testing for the equipment related to this and to assure that equipment is fit for use in accordance with cGMP. The protocol shall be reviewed and authorised by the stated personnel in the approval box prior to execution of IOPQ. The IOPQ execution shall be reviewed and approved prior to summary write up. Upon completion of the IOPQ, a final review will be done and signed off.

Objectives The objectives of this Installation, Operational and Performance Qualification (IOPQ) protocol is to ensure that the [ Name Process Here ] has been installed and operates retrospectively and is fit for use in accordance with cGMP and Health and Safety requirements.

Pre-requisites Identify activities and tasks that must have been executed, been completed and approved prior to commencing the IOPQ activities. At a minimum, the following are prerequisites.

•The process must be listed on the Validation Timeline.

•The process must be deemed to require Validation and be documented on the Validation Plan.

•The VP Deliverables checklist must be prepared.

•The VMP document must be written and approved.

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VALIDATION PROTOCOL Your Logo

Document Title: (describe here)

Test IQ1) Description and Reference Numbers Objective

To record details of the components that comprise [Add Process/ Equipment Name Here]

Method

Record all details in the table below

Acceptance Criteria

All details recorded in the tables below

#

Actual Details (Description/Serial No. Performed By etc.)

Initial / Date

Unit Description

1

2

3

4

5

6

Acceptance met

YES / NO – If NO, record Concession number: ……………………..

criteria

Completed By Sign

Date

Sign

Date

Verified By

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VALIDATION PROTOCOL Your Logo

Document Title: (describe here)

Test IQ6) Documentation Review Objective

Manuals and Technical Documentation Verification

Method

List all applicable equipment manuals and verify they are filed, under control and available for reference.

Acceptance Criteria

All applicable SOPs and equipment manuals are filed and under control.

Document # (list details Location below)

Title

Acceptance met

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criteria

Pass Performed By Fail Initial / Date

YES / NO – If NO, record Concession number: ……………………..

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VALIDATION PROTOCOL Your Logo

Document Title: (describe here)

[Ensure all sections are completed prior to progressing to OQ]

Operational Qualification The OQ must only commence with the satisfactory completion of IQ. Add a brief summary of the OQ here.

Operational Functional Tests [add/remove rows as applicable] Product Range Selected ………………………………………………………………….

Test Summary (detail the tests here and add a summary where appropriate) Start Machine as normal, following user manual and perform the following function checks:

Test No. OQ1 OQ#

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Test Description

Acceptance Criteria

Pass/Fail

Initial/ Date