Performance Qualification (PQ) Protocol & Report Format In Pharmaceuticals.

Performance Qualification In Pharmaceutical Industry.

Systems and equipment should consistently perform in accordance with
design specifications. The performance should be verified in accordance with a
performance qualification protocol.
There should be documented records for the verification of performance
(performance qualification report) to indicate the satisfactory performance over
a period of time. Manufacturers should justify the selected period over which
performance qualification is done.

Format for a Performance Qualification Protocol

Validation protocol _________ Performance Qualification _________ Page _____ of _____
Title: ______________________ Name of facility: ____________________________________

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Validation Protocol # _______________________ Performance Qualification
Title ____________________________________________________________________________

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Protocol written by _______________________________________________________________
Departmental Approval by ____________________________________ Date ____________
QA Approval by ______________________________________________ Date ____________

Objective:-

To determine that the systems/equipment perform as intended by repeatedly running the system on its intended schedules and recording all relevant information and data. Results must demonstrate that performance consistently meets predetermined specifications under normal conditions, and where appropriate for worst case situations.

Scope:-

To be performed after the Installation and Operational Qualification have been completed and approved.
To be performed after installation, modification or relocation and for re-validation at appropriate intervals.
Each piece of equipment must be validated before it serves another piece of equipment/ system during validation of the latter (e.g. water system before steam generator; steam generator before autoclave).

Responsibility:-

Person responsible for operating the system or equipment will perform the qualification and record the information.
The supervisor will supervise the study, verify the completion of the records and write the Deviation Report and the Performance Qualification Report.
Qualify Assurance will review and approve the Performance Qualification Protocol and Report.

Materials, Equipment, Documents:-

SOPs for normal operations of the equipment or system under test (including data record forms, charts, diagrams materials and equipment needed). Attach copies.
SOP list:-

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SOPs specific for performance tests (including data record forms, charts, diagrams, materials and equipment needed, calculations and statistical analyses to be performed, and pre-determined specifications and acceptance criteria). Attach copies.
SOP list:

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Procedure:-

Equipment: Run normal procedure three times for each use (configuration or load) and record all required data and any deviations to the procedure.
Systems: Run for 20 consecutive working days, recording all required data and any deviations to the procedure. Prepare the Summary Data Record Form(Chart 1).

Evaluation:-

• Attach all completed, signed data record forms.
• Complete the Summary Data Record Form (Chart 1).
• Perform all required calculations and statistical analyses (Chart 2).
• Compare to acceptance criteria (Chart 3).
• Prepare Deviation Report including the justification of acceptance and impact on the performance.
• Prepare a Performance Qualification Report: This should include: date study initiated; date completed; observations made; problems encountered; completeness of information collected; summary of deviation report; results of any tests; do results meet acceptance criteria; location of original data; other information relevant to the study; and conclusions on the validity of the equipment/system.
• Submit Performance Qualification Document to QA for review and approval.

Chart 1: Summary Data Record:-

(To be prepared for the specific procedure being tested)

Performed by: _____________________________________________ Date ____________
Verified by: ________________________________________________ Date ____________

Chart 2: Calculations and Statistical Analyses:-

Performed by: _____________________________________________ Date ____________
Verified by: ________________________________________________ Date ____________

Chart 3: Acceptance Criteria vs. Performance Test Results:-

Criteria                                           Results                               Pass/Fail

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Performed by: _____________________________________________ Date ____________
Verified by: ________________________________________________ Date ____________

Deviation Report:-

Deviation(s):

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Justification for acceptance:

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Impact on operation, function or process:

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Written by: _____________________________________________ Date ____________
Verified by: ________________________________________________ Date ____________

Performance Qualification Report:-

Results:

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Conclusions:

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Written: _____________________________________________ Date ____________
Verified by: ________________________________________________ Date ____________

Reference :-

WHO – Quality Assurance Pharma Vol2.