IQ Template for Medical Devices Sample

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Protocol Approval

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INSTALLATION QUALIFICATION VALIDATION PROTOCOL FOR [NAME HERE] 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 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 Qualification 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 OQ. The IQ execution shall be reviewed and approved prior to summary write up. Upon completion of the IQ, a final review will be done and signed off.

Objectives The objectives of this Installation Qualification (IQ) 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 IQ 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.

•The ‘Pre-requisites to Validation Activities’ Stage Deliverables (identified on the VP Deliverables Checklist) must be completed and approved, or at least ongoing with scheduled target dates and the responsible person identified.

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VALIDATION PROTOCOL Your Logo

Document Title: (describe here)

•The IQ Checklist Charts must be prepared, using data/documentation from the ‘Prerequisites to Validation Activities’ stage.

Product predetermined specifications and quality attributes must be established and documented.

Test method and measurement systems must be established and qualified.

Calibration of test equipment and instrumentation used during the IQ must be within its calibration frequency.

Batches used for the IQ must be identified in a manner that prevents unintentional release of product.

Report Upon completion of the IQ protocol the findings must be summarised in an IQ Summary Report. The following must be reported within the summary: Any corrective actions identified during the execution of this protocol have been deemed not to impact on the IQ, and have been completed and approved.

Any non-conformances identified during the execution of the protocol have been investigated and deemed not to impact on the validation status.

Any deviations to the protocol, specification or requirements have been investigated and evaluated, and deemed not to have an impact on the validation status.

Supporting Data/Documentation is referenced for traceability. Where documented evidence is to remain with the Validation package, this is adequately labelled/identifiable, as well as signed and dated by the person responsible.

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VALIDATION PROTOCOL Your Logo

Document Title: (describe here)

Index of IQ Test Reference

Test Name

IQ Section 1

Description and Reference Numbers

2

Mechanical, Electrical Checks

3

Critical Components

4

Maintenance and Calibration Checks

5

Availability of Software

6

Documentation Review

7

Health and Safety Checklist

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