Best Value of Performance Qualification (PQ) 22.

Performance Qualification (PQ) is part of the validation master plan in pharmaceutical organizations. This is the method to check the effectiveness, quality, efficiency, and overall performance of the equipment.

In a pharma plant, it is necessary that before starting the actual production on the machine it must be qualified through performance qualification protocol and reports with complete documentation and evidence.

PQ protocol is the verification and documentation evidence that all equipment is working within the accepted range as specified or performs as per our requirements.

Performance Qualification Protocol’s Steps:

The Performance qualification protocols of the equipment include the following steps:

• A list of the data that must be analyzed or documented during the testing process is called a data summary.
• Manufacturing conditions component inputs, operating parameters, and equipment environment.
• Calibration and validation.
• Sampling plan.
• Analysis methodology.
• Variability limits.
• Contingencies for non-conformance and its reports.

Steps to prepare & execute the PQ protocol & reports:

1. PQ Protocol and reports Pre-Approval
2. Introduction and Objective
3. Scope
4. Reference Document
5. Complete System description
   1.  Use
   2. Capacity
   3. Operation & Design Feature
6. Performance Qualification Test Plan
7. Responsibility
8. Test Execution Method
9. Acceptance Criteria
10. Summary Report and Conclusion
11. Enclosed Document
12. Abbreviation

PQ Protocol and reports Pre-Approval:

The PQ protocol and report document is prepared by the Validation team of the pharma plant and reviewed by every department SME and then the PQ protocol and report document are finally approved by QA Head.

Introduction and Objective:

The PQ document is applicable for pharma equipment that is purchased from vendor (Vendor Name). This machine should perform on the basis of design, installation, operation, and specified parameters.

Mention Make and  Model:

The objective of developing a performance qualification document is to establish the methodology for performance qualification in order to ensure those plant requirements for the project are met according to technical and functional specifications.

Scope:

Performance Qualification is an essential part of the qualification mechanism.  The scope of this protocol is to provide complete documentary evidence for the performance qualification of the pharma machine.

• To ensure the machine meets the cGMP requirement.
• To confirm the appropriateness of critical parameters of the blister packing machine components.
• To validate the system and check its performance.

This document has the Operational Qualification procedure and process flow that how to check and verify the pharma equipment operation.

Pharma Equipment Name:                        Mention Name

Pharma Equipment Model:                        Mention Model Number

Pharma Equipment ID:                                Mention ID

OEM Name and address:                             Mention OEM name & address

Equipment installation Location:              Mention Location

Floor:                                                               Example Ground Floor

Room name & number:                               Mention room name & ID

Reference Document:

Mention the documents name which is referred for the preparation and execution of the PQ protocols & reports.

•  Validation Master Plan.
• OEM user manual.
• URS & TBA or design basis documents.
• Design Qualification documents.
• Installation Qualification documents.
• Operational Qualification.
• Risk Assessment
• Supplier design document GA drawing, P&ID, and PFD.

Complete System Description:

Utilization:  mention the utilization of the equipment, for example, equipment used for mixing drugs or filling drugs, etc.

Capacity; Mention the capacity of the equipment like volume, weight, or output of the equipment.

Operation & Design Feature: (We are taking the example of a stability chamber)

The stability chamber is a double-wall insulated chamber.

The inner chamber contains fix number of perforated trays for forced air circulation and uniform temperature distribution.

Chambers have built temperature & humidity sensors.

Chamber has a metal door with a glass window with a magnetic gasket and lock.

The stability chamber has the following systems and accessories for the desired functioning:

Control System: It has an automated control system linked to a computer for monitoring, data logging, and controlling.

Heating System: The heating system contains SS tubular heater with tubular heater fins.

Cooling System: The cooling system consists of a hermetically sealed compressor coupled with an evaporation coil and condenser. Safeguarded by the time delay circuit.

Humidity System: humidity systems contain safety relays to control the humidity in the chamber.

Alarms: Audio and visual alarm is generated for temperature, RH variation, and utility failure.

Safety Device: Walk-In Humidity chamber is provided with a safety device for temperature & RH overshoot in case of malfunctioning.

Performance Qualification Test Plan:

For pharma equipment please take three consecutive bathes for the performance qualification test that should be performed for different parameters of the pharma machine.

• Operate the machine as per SOP.
• Set the parameters as per requirement.
• Produce the product and observe the parameters at slow, medium, and high speeds.
• Collect online samples and check the parameter corresponding to them.
• Record all the details.
• Run Size: Each run will be conducted for a minimum of 30 minutes to demonstrate a continued run.
• Number of Runs: minimum of three runs will be conducted for each combination of machine speed and target output to demonstrate the reproducibility of the equipment.

Responsibility:

Test Execution Method

Pre –Requisites:

• The system should be safe for execution.
• Approval of operational qualification report.

Signature Registration & Training:  

• Execution of PQ protocol.
• Writing GMP critical record.
• Deviation handling procedure.
• Review of executed validation protocol and GMP critical records.

General Recording Instruction:

• Execution will be carried out as per the SOP for Qualification protocol execution.
• In the test data, sheet test parameters and criteria will be pre-defined.

Deviation Handling:

• During execution, the comments if any shall be noted in the respective datasheet.
• During review or execution, all comments shall be verified and if any comment is made to specify non-compliance to that test acceptance criteria, the comment shall be escalated as “Deviation”
• Analyze the deviations.
• Resolve the deviations if any.

General Safety Instruction for Execution:

• Check all safety parameters
• Check all utilities are safely connected, isolated, and energize or de-energized.

Acceptance Criteria:

The Equipment successfully passes PQ if all the test specifications are passed or open tests are justified and accepted.

• Meets the Specifications and Quality requirements identified by the User
• Is correctly performed and documented.

Summary Report and Conclusion:

All tests and results shall be evaluated and the PQ report (format enclosed) shall be formally approved. During the review of the report, it is necessary to assess to what extent all tests were successfully completed.

Enclosed Documents:

The following documents are attached to the operational qualification protocol:

• General Function test
• Verification of Human Machine Interface (HMI)
• Verification of inputs and outputs
• Verification of alarm and interlocked operation
• User access test
• Verification of configurable parameter
• Verification of power failure
• Real-time clock verification
• Verification of database backup & restore
• Verification of interface and communication
• Verification of Printer and cycle printouts
• Verification of Event logging & data Integrity
• Operator training Verification
• Emergency Stop
• Verification of Noise Level
• System Performance Verification
• Verification of measures identified in Risk Analysis
• Comment Summary Sheet

Abbreviations:

cGMP                                   Current Good Manufacturing Practices

EHS                                      Environment Health & Safety

IQ                                          Installation Qualification

OQ                                        Operation Qualification

PQ                                         Performance Qualification

P & ID                                  Process & Instrumentation Diagram

QA                                         Quality Assurance

SOP                                      Standard Operating Procedure

VMP                                    Validation Master plan

SME                                    Subject Matter Expert

OEM                                   Original Equipment Manufacture

Frequently Asked Questions:

If you want a draft copy or any other details about the pharma equipment/machine qualification like  DQ, IQ, OQ, PQ,  please write us at: admin@flairpharma.com