OPQ Template for Medical Devices Sample

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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 OPQ 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 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 OPQ. The OPQ execution shall be reviewed and approved prior to summary write up. Upon completion of the OPQ, a final review will be done and signed off.

Objectives The objectives of this Operational and Performance Qualification (OPQ) 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 OPQ 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)

•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.

•The OPQ 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 OPQ must be within its calibration frequency.

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

The OPQ Protocol must be written and approved, and any data sheets required for the PQ have been prepared.

Report Upon completion of the OPQ protocol the findings must be summarised in a collective OQ/PQ 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 OPQ, 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)

Performance Qualification This is the Performance Qualification protocol for the Process Validation of [name process here] which comprises of: -

[Name components of Validation here]

The above equipment has successfully completed a Retrospective/ Prospective/ Concurrent [delete as appropriate] IQ/ OQ (Installation and Operational Qualification).

This protocol is a Retrospective/ Prospective/ Concurrent [delete as appropriate] PQ which shall incorporate sample tests of all the above equipment to minimise production loss. In addition, this procedure will also enable the concurrent validation to perform with production batches as well as test the limitations of the equipment as a process and not an individual piece of equipment. The justification of using production batches without conclusive evidence of satisfactory validation completion will be authorised by the Quality and Compliance Manager, based on the historical data of the machines running successfully for many years. Sample tests shall be taken from each of the above processes and Works Order. The acceptance criteria for each piece of equipment shall be defined.

Therefore it is imperative that checks are thoroughly documented according cGMP recommendations. This PQ shall verify that the equipment is suitable to repeatedly and reliably produce product of acceptable consistency to improved quality standards.

In accordance with 21 CFR part 820: “Validation means confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled” In compliance with these FDA guidelines, consistency is generally demonstrated by three consecutive batches of production.

All testing will be performed retrospectively/ prospectively/ concurrently [delete as appropriate] since there is historical data since its installation, and all tests will be in accordance with Pharmi Med Validation Policy which is outlined in “Validation Master Plan – PLCNPD001” The rationale and outcomes from the OQ have been incorporated into this PQ for running a consistent and repeatedly reliable process.

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VALIDATION PROTOCOL Your Logo

Document Title: (describe here)

PQ Tests Summary The following tests have been identified as imperative checks on the line. These individual processes have been OQ tested successfully. Running a range of products through in normal operating conditions will allow the entire line to run with consistency of quality and repeated results. This shall be proven by sample checks at each point of the line process, as identified in these tests. [expand/ delete where necessary] Product Range Selected………………………………………………………………………………………

Test No. PQ1

Test Description (List asset number below) cGMP Review

PQ2

Review for Completeness

PQ3

Signatures

PQ4

Line Clearance

Line Clearance was done and complete

PQ5

Start Up

PQ6

In Process Checks

PQ7

Documentation

Start Up Checklist has been completed correctly In process hourly checks have been completed with accuracy All relevant attachments are provided

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Acceptance Criteria Ensure Works Order Documentation is fully complete to cGMP. Ensure relevant information is complete on batch documents All areas are signed of N/A

Pass/Fail

Initial/ Date

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VALIDATION PROTOCOL Your Logo

Document Title: (describe here)

PQ8

Comments

Ensure comments are traceable

PQ9

Labels

PQ10

Legibility

Ensure correct labels are fixed at the correct location Ensure all entries are legible

PQ11

Customer Complaints

PQ12

Deviations/NCRs

PQ13

Stoppage Log

PQ14

Line Log

Check the log to report any issues

PQ15

Training

Ensure all operators on documentation have received training

Check if there have been any customer complaints due to the batch Check to see if there are any Deviations/ NCRs raised as a result of batch production Check any report to review for stoppages

Ensure Works Order/ Batch Record is photocopied and appropriate checks carried out.

This must be attached to the executed protocol.

Acceptance met

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

criteria

Completed By Sign

Date

Sign

Date

Approved By

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