Equipment Operational Qualification (SOP) is the process, which establishes through verification and documentation that the equipment is capable of operating within established limits and tolerances. This demonstration of basic performance must involve operational aspects of the equipment that will be routinely used in manufacturing.
OBECTIVE:
This guideline defines the minimum requirements for facility regarding the Equipment Operational Qualification (SOP) which must be performed following Installation Qualification (IQ) and prior to process, system qualification.
SCOPE:
All critical equipments will require successful completion of Operational Qualification (OQ).
For New Equipment:
OQ must be completed prior to manufacture of product for process validation.
For existing equipment:
A determination of critical operating parameters must be performed based on available documentation.
DEFINITIONS:
Operational Qualification (OQ):
Equipment Operational Qualification (SOP) is the process, which establishes through verification and documentation that the equipment is capable of operating within established limits and tolerances. This demonstration of basic performance must involve operational aspects of the equipment that will be routinely used in manufacturing. Verification test data will be collected, reported, and reviewed.
Critical Manufacturing Equipments:
Critical manufacturing equipments are those pieces that have direct product contact or have the potential of affecting the quality of the product. All critical manufacturing equipment must be included in the change control program once satisfactory Equipment Operational Qualification (SOP) has been completed.
Objective:
The objective of this document is to outline the Operational Qualification (OQ) requirements and the acceptance criteria for the equipment operating in SPL facility. Successful completion of OQ will establish confidence that the process equipment is capable of operating within established limits and tolerances.
Acceptance Criteria:
Equipment must meet all the operational challenge tests performed on the system over the full operating range as defined by the specification. The data must be reviewed and declarations issued starting the results are acceptable.
If results of any operational challenge test do not meet the acceptance criteria: perform an investigation; take corrective actions (if appropriate); repeat the challenge test; and prepare a summary of these events.
RESPONSIBILITY:
Engineering Department (or Equipment Supplier):
- All critical instruments, if applicable, must be calibrated against the specifications. Calibration documentation must be available at the Engineering department.
- Identifying the critical parameters required by the process for the intended use of this equipment and providing testing data for review upon request.
- Coordinating the qualification with the appropriate individuals and departments.
- Verifying that the qualification test requirements are completed.
- Certifying successful results and preparing pre-release documentation.
- Completion of the report.
- Develop appropriate SOPs based on successful OQ.
Manufacturing Department:
- Overall adherence to this work instruction.
- Verifying that the report requirements are completed and prepared for approval.
- To review qualification the final reports.
Validation Coordinator:
- Reviewing and approving the qualification data and the final qualification report.
- Ensuring operator’s safety during the qualification.
- Review the appropriate SOPs.
PROCEDURE:
The Following information should be stated in the equipment OQ protocols:
Equipment Description:
- Identify the name, location and purpose of the equipment and describe the process activity.
- If the inspection or verification test is not satisfactory, complete a deviation report form to document the deviation (if any). Indicate any corrective action or other appropriate action taken and submit for approval.
- List and briefly describe the function of each critical part of the equipment. This should include a statement of how the identified unit should normally operate.
- Include a statement describing any limiting parameters of the equipment (e.g. bottle size such as smallest, largest and most commonly used size, if appropriate).
Calibration Requirement:
- Indicate the parameters to be monitored including the acceptable range or limit.
- Include all critical measuring and monitoring devices such as timers, pressure indicators, and temperature sensors or any chart records that document performance.
- Document all calibration testing.
Preliminary Checks:
All tasks required for initial start-up and those appropriate for annual or periodic evaluations must be performed. These activities may be software checks, cycle set points, gasket integrity valuation, etc. The vendors Operating & Maintenance Manual (O&M) will be required for all checks.
Engineering Drawings:
Describe each activity in detail in the protocol and report or reference it in an appropriate Work Instruction.
Operation Criteria:
- The operational qualification should clearly list all critical operating parameters and their corresponding test functions.
- A critical operation is one, which has significant impact on the equipment ability to operate and meet process specifications satisfactorily and is challenged through the use of an appropriate test function. Several critical operating parameters for a mixer, e.g., would be speed, rotation and time.
- All test instruments used in the qualification should be calibrated and the documentation to support to calibration should be included in the qualification report.
Challenge Testing:
Engineering department will execute the challenge test and document the results and determine if the acceptance criteria were met. The tests to be performed include the following:
- Correct functionality of the control switches.
- Correct functionality of the machine sensors.
- Test the safety devices and alarms.
- Equipment performance complies with the expected results and performs the intended function.
Non-Electrical Utilities Verification:
Equipment Operational Qualification (SOP) Complete a list of all requirement utilities (non-electrical). Verify that they are available and conform to specifications. Inspect the connections from the distribution system. Include any documentation in support of the results and method of verification.
Filter List:
Complete a filter list based on information from purchase orders and equipment specifications. Verify that the items have been installed as specified. Indicate position number, equipment code number, manufacturer and description of each item, as applicable.
Product Contact Material Review:
Identify the materials of construction of product contact surface of the equipment components. Verify that they conform to specifications and will not adversely affect the product.
Lubricant List:
Complete a list of the lubricants used in the equipment. Verify that they conform to the equipment manufacturer’s specifications.
Instrument List:
Complete a list of all equipment instruments. Designate instruments as “critical” or “non-critical”. Critical instruments are used for process controls and are defined as those whose performance will affect the operation of the equipment or the quality attributes of the processed material. Non-critical instruments are those provided for information only and are labeled as “Reference Only”. Include tag number, manufacturer, location, and description of each item, as applicable.
Ensure that all critical instruments/sensors have been calibrated as per applicable calibration control procedure requirements. Verify that the re-calibration interval for critical instruments/sensors is indicated and that a copy of the completed calibration is on life.
Work Instructions/Procedures Review:
Assure that all associated WIs/Instructions/Procedures are available, complete, current, accurate and in compliance with cGMP (i.e. Preventive Maintenance, Calibration etc.)
Equipment Control System:
Identify and document the equipment control panels. Confirm that control panels are installed in conformance with design and/or manufacturing specifications.
Qualification Completion and Approval:
Verify that all tests required by this guideline are completed, reconciled and attached with the summary report. Verify that all amendments and deviations are documented, approved and attached to the report. If all items in the Equipment Installation Qualification have been reviewed and found to be acceptable, approve the report.