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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.
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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
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