PQ Template Sample

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PERFORMANCE QUALIFICATION PROTOCOL FOR [NAME HERE] Your Logo

Protocol Approval

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)

PQ Rationale 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 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 Your Company Validation Policy. The rationale and outcomes from the OQ have been incorporated into this PQ for running a consistent and repeatedly reliable process.

Protocol Number: : (add assigned no.)

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VALIDATION PROTOCOL Your Logo

Document Title: (describe here)

Test #

1

Test Name

Production Batches for XX batches to test for consistency (determine number of batches)

Acceptance Criteria

Sample size must pass

PERSONNEL Record below all personnel involved in the execution of this protocol: Company

Name

Job Title

Signature

Initials

TEST EQUIPMENT REQUIREMENTS The following table details the test equipment required for the execution of this protocol: Test Equipment

Test Equipment Purpose

Serial Number

GLOSSARY IQ OQ PQ SOP cGMP

Installation Qualification Operational Qualification Performance Qualification Standard Operating Procedure Current Good Manufacturing Practice

Protocol Number: : (add assigned no.)

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