Best Value of Operational Qualification (OQ) (22)

OQ is the Operational qualification that will perform after the successful completion of Installation Qualification. OQ is the major key step of the Validation Master plan. Through OQ protocol we ensure the actual operation of the equipment/machine. OQ protocol is generally provided by OEM also some organization made their in-house protocols and reports on basis of OEM documents. is the next step in quality assurance and involves testing the equipment and making sure it performs as specified, within operating ranges as listed by the manufacturer.

All aspects of the equipment receive individual testing and the tester documents the proper operation of each.

After installation, extensive maintenance, upgrades, or as part of routine quality control testing, operational qualification of the equipment is needed.

Leveling and fluctuation, consistency, keyboard controllers, deviation reports, configuration, certificates, as well as performance reports are examples of operational qualification elements that may be checked.

Steps of the PQ Protocols:

• Pre-approval
• Objective
• Scope
• Reference document
• Equipment description
  • Utilization
  • Capacity
  • Operation & design feature
• Operational qualification test plan
• Responsibility
• Test execution method
• Acceptance criteria
• Summary report and conclusion
• Enclosed documents
• Abbreviations

PRE-APPROVAL:

The PQ document is prepared by the Validation team of the pharma plant and reviewed by every department SME like QC, Micro, production, etc. and then the QO document is finally approved by QA Head.

Objective:

The main purpose of the Operational Qualification document is to establish documented evidence, that the equipment operation is working fine after its successful installation is in accordance with the requirements of design documents & is as per URS.

Scope:

The document has the Operational Qualification procedure and processes on how to check and verify the pharma equipment operation.

 The following details will mention while detailing the scope:

•   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

This protocol is generated to qualify the operation of the equipment. In case of further modification or relocation, some part of the same protocol can be used or a separate protocol or addendum can be generated.

 Reference Documents: 

Mention the document’s name which is referred to preparing and executing the OQ protocols & reports. Some examples are below:

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

Equipment Description:

Provide a brief description of the pharma equipment.

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 vial filling machine so firstly we check,
• Check the Infeed turntable is working properly and transfer the empty vials to the provided infeed conveyor of the filling machine.
• Check the interlocking of the infeed conveyor of the filling machine to the tunnel.
•  Check the Vial filling station is equipped with pre and post-nitrogen purging & check for its operation.
• Check the operation of filling needles or filling stations.
• Check for the positioning of the needle synchronized with the vials in the rack.
• Now check the bungs are charged in the feeding hopper & bungs oriented in line and engage in a bunging disc with the help of the vibrator.
• Then check the bungs will tighten on the vial mouth.

Operational Qualification Test Plan:

Operation qualification has the following activities and tests:

 General Tests:

• Availability of IQ test report.
• Document verification.
• General Function test.

Automated control system verification:

• Verification of Human Machine Interface (HMI).
• Verification of inputs and outputs.
• Verification of alarm and interlocked operation.
• User access test.
• Verification of configurable parameters.
• 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.

 Specific operational test:

The specific operational test is designed based on the requirement identified during risk analysis

• Operator training Verification.
• Emergency Stop.
• Verification of Noise Level.
• Control System and its Performance Confirmation.

Responsibility

Responsibilities of different departments/ personnel/SMEs involved in different activities during the operational qualification:

• Preparation of OQ protocol.
• Review of the protocol.
• Approval of the protocol.
• Clearance of the equipment for execution.
• Execution of OQ protocol.
• Preparation of OQ report.
• Review of the executed OQ protocol and its report to be done by QA team.
• Approval of the Executed OQ protocol and report.

Test Execution process:

Pre –Requisites, Prior to conducting/ executing the operational qualification protocol following conditions must be fulfilled:

• The system should be safe for execution.
• Approval of Installation Qualification report

Training:

All personnel who are executing or reviewing the protocol must enter his/her name and signature on the signature registration page. Provide the location of the training record or attach the appropriate training record with the report to indicate that the personnel should be trained on the following:

• Execution of OQ protocol
• Writing GMP critical record
• Deviation handling procedure
• Review of executed validation protocol and GMP critical records
• The signature registration page should be given as Datasheet.

 General Instruction and process:

• The comment summary sheet is attached e separately as Datasheet.
• Comments and deviations will be recorded as per the instruction given in the following section.

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 pharma equipment successfully passes OQ with all test specifications.
• Thus, it is stated that the equipment meets user and quality requirements.

Summary Report and Conclusion:

• To final closure of the OQ, evaluating the OQ protocol/report shall approve.
• Now OQ report is approved and proceed to the next test phase (PQ) process.

Attached 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 parameters.
• 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

DQ                                         Design Qualification

URS                                      User Requirement Specification

IQ                                          Installation Qualification

OQ                                        Operation 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, or OQ, please write us at: admin@flairpharma.com