In the pharmaceutical industry, equipment plays a vital role. So, it is compulsory to make sure that the equipment are safe, efficacious and reliable in producing quality products. This is also important from a regulatory point of view, which allows for regulatory compliance as well. There are validation processes that confirm that the system, equipment or processes are performing as they must be. Read below to know more about them.
IQ, OQ And PQ Definition
What Is Installation Qualification?
Installation Qualification or IQ is a verification process in which it verifies that the instrument or part of an equipment (including any subsystems and ancillary systems) has undergone proper installation and configuration as per the specification of the manufacturer or the installation checklist.
What Is Operational Qualification?
Operational Qualification or OQ is the process which involves the identification and inspection of the features of the equipment which can affect the quality of the final product.
What Is Performance Qualification?
Performance Qualification is the final step in the qualification of equipment. In PQ, the qualification as well as the validation team perform verification and documents that the user requirements are verified as it is being fulfilled.
Process Validation: IQ, OQ And PQ
A process validation that is effective will contribute to quality products.
Installation Qualification Validation
Performance of a hardware or software unit in a real-world setting is dependent on the installation procedure. Let it be a physical or software unit, the goal of IQ is to check whether the system has all the necessary conditions for it to function as expected.
In addition, CGMP requirements relevant to and the methodology used for IQ should be documented in the Validation Master Plan (VMP) thoroughly. Following the initial IQ, re-qualification must be conducted after any major maintenance or modification of the equipment. As part of routine quality assurance processes, re-qualification should also be conducted.
How good did the installation process follow the guidelines of the manufacturer and their requirements? This is how usually it is determined whether an IQ is successful or not. Here are some areas it includes:
Location of installation and appropriate floor space.
Documentation of computer-controlled instrumentation, if any.
Connection of the system to a proper power supply
Cross checking the instruments with a packing list after unpacking.
Collection of manuals and certifications available.
Examining the system for any damage
Making sure of the environmental and other operating conditions.
Installation of any ancillary instrument.
Firmware version and serial number documentation
Recording the last calibrated or validated date of the tools used in performing IQ.
Operational Qualification Validation
This is the next validation step after IQ. OQ is done only after the IQ protocols are met. Operational qualification is conducted to confirm that the equipment is working as it is claimed to be by the manufacturer. To know whether it is consistent with the user requirements and manufacturer specifications. So, at the time of OQ, all the items as per the test plan will be tested. Performance is properly documented as well.
Areas in which OQ is involved but not limited to are:
Temperature control, distribution and protection system
Displaying and signaling units
Servo motor and air flaps
Measuring humidity and its control system
Card accessing and reading systems
Carbon Dioxide control systems
Fan/ fan speed controllers
After completion of OQ check if:
It satisfies all the acceptance criteria mentioned in the OQ protocol, significant deviations and non-conformities showing the proper functioning of equipment are not identified, the built-in error detection and handling mechanism work properly, it can combine with other systems or processes without any issues if applicable, positive feedback from operators and end users. If all these are met, the OQ is said to be successful.
Performance Qualification Validation
PQ or performance qualification is the final step in the qualification of equipment. The qualification and verification team conducts the verification and documents that the user requirements (along with the normal operating range required) are being fulfilled. After the equipment has been qualified, specific processes for each product are developed. Once processes are completely developed, it is then validated.
Rather than individual testing of the instruments or components, it is tested as a partial or overall process. But before any tests can take place, a detailed test plan must be created based on the process description. In the FDA guidance document, the PQ stage has 2 elements.
Design of the facility and qualification of the equipment and utilities
In part 211, subpart C of the CGMP regulations of buildings and facilities it is stated that proper designing of the manufacturing facility is required. Facility design, commissioning and activities conducted to assure them must come first before PPQ and manufacturing of the product at a commercial scale. This is important because it serves as the foundation for the rest of the phases.
Process Performance Qualification (PPQ)
In PPQ, the actual facility, equipment, utilities, trained person with the commercial manufacturing process, control procedures, and components to create commercial batches are combined together. To establish the manufacturing conditions in PPQ, cumulative data of all the relevant studies should be used.
Conformation of the product design and performance of the commercial manufacturing process is as expected is demonstrated when a PPQ is a success. Successful completion of PPQ will lead to commercial distribution of the product.
Installation Qualification Documentation & Protocols
IQ Protocol: An Installation Qualification protocol is designed to outline the methodology, scope and criteria for the conductance of an IQ. It includes the following:
Identification details of the equipment like the model, manufacturer and the serial number.
A list of equipment as well as systems that are to be qualified.
Installation requirements according to the manufacturer's specifications.
Environmental condition requirements like the temperature and humidity.
An installation criteria checklist to be verified.
IQ Checklist: A detailed checklist drafted from IQ protocol. It must cover all the aspects including physical/software installations, calibration, electrical connections and environmental conditions to be verified.
IQ Report: This report documents how the protocol was executed. Summary of the findings/observations and results are included. It should also state clearly whether the equipment installation satisfies the predefined criteria.
Operational Qualification Documentation & Protocols
OQ Protocol: An Operational Qualification protocol is designed to outline the methodology, scope and criteria for the conductance of an OQ. It includes the following:
Objectives: State exactly what the aims are to achieve, together with specific operational parameters and functions to be tested if any.
Scope: Explain the systems, equipment and processes within the OQ.
Methodology: Step by step procedure to be described on conducting the operational tests, any set ups or conditions required included.
Criteria for Acceptance: It must be based on the manufacturer's specifications, user needs and regulatory requirements.
OQ Test Scripts/Checklist: Detailed checklists used to conduct the tests specified in the protocol.
OQ Report: OQ testing execution and outcomes are documented here.
Standard Operating Procedure: This is important to ensure the correct and consistent working of the equipment in the operational tests.
Calibration and maintenance record: Records must be kept as proof of the proper calibration and maintenance of the equipment before as well as during the OQ tests.
Traceability Matrix: It makes sure that all the appropriate operational parameters are tested and validated against the requirements.
Performance Qualification Documentation & Protocols
As we have already discussed, the PQ stage has 2 elements. Out of which the Process Performance Qualification elements describe the PPQ protocol. This has significant importance as its purpose is to make sure the ongoing product quality by documenting it over a period of time.
PPQ Protocol: This protocol must include the following elements:
Manufacturing conditions along with the processing limits, operating parameters and component inputs.
The data to be recorded, how and when will it be evaluated.
Tests were conducted to confirm consistent quality all over the production.
Sampling plan describing the methods of sampling used during and in between the production batches.
Based on the statistical data, the analytical methods used in order to make data, scientific and risk-oriented decisions.
Description of the variability limits as well as the contingency plan for managing nonconformance.
Approval of the protocol by the quality unit and all other relevant departments.
Regulatory Requirements For IQ, OQ & PQ
21 CFR Part 820.75 speaks about the process validation. As per the Code of Federal Regulations (CFR) subpart G it is stated that:
With subsequent tests and inspection, the results of the process cannot be completely verified, then a higher degree of assurance the process should be validated, and it must be approved as per the procedures established. The activities of validation and its result along with the date and signature of the person(s) involved in approving the validation and also the equipment validated where necessary should be documented.
In order to make sure that the specific requirements are satisfied, the manufacturer must set forth and maintain procedures for control and monitoring of process parameters for validated processes. It is a requirement to perform the validated processes by a qualified individual. This must be made sure by the manufacturer. When there are any changes or deviations in the processes, the manufacturer is responsible for reviewing and evaluating it. A revalidation must be conducted, and it should also be documented.
Common Challenges Faced In IQ, OQ, and PQ
One of the major challenges includes the combination of business goals, deadlines and lack of understanding of what must be included to put up a complete technical file. A person working in this field for about 28 years has stated that companies fail to define and validate requirements from the very beginning itself. They realize this when they start to act on the technical file. They come to know that customer requirements and processes are not validated.
It has become more commercially driven. The companies are providing justifications to not go through the number of tests compared to 30 years back.
Best Practices For Successful Qualification
Before each qualification process (IQ, OQ and PQ) can take place, a protocol is designed and as per the protocol is the conductance of the processes. So proper preparation of protocol is a crucial step in successful qualification.
Recognize potential risks that are associated with the installation of the equipment and lead IQ activities based on the risks. Conducting these activities makes sure that the elements affecting the quality and safety are addressed. Reviewing previous IQ protocols for similar equipment, if possible, will help to understand the common failures and challenges. Prepare for the effect of environmental conditions on the installation process.
Test the equipment in all possible conditions that it is meant to operate. This is done to confirm that the equipment is operating well in its operating range as it is claimed to be. Create failure and error scenarios deliberately so as to check whether its error function is on point or not. This action shows us whether the equipment is reliable for its error management system. Use tools and technologies that would allow for real time monitoring. This will help in gathering the data instantly at the time of PQ and PPQ.
IQ, OQ, And PQ Example In Pharmaceuticals
A common example is the autoclave machine.
IQ Examples: Checking if the autoclave is placed properly in the sterilization room. Checking for proper connections for electricity, water and steam. Does it meet environmental requirements like ventilation, appropriate room temperature and humidity control. Verification of installation documents such as manuals, certificates and all the components are installed properly.
OQ Examples: To confirm that the autoclave is operating as it is intended to be. Checks whether the equipment can achieve the required temperature (121°C) and pressure (15 psi) during the sterilization process. Testing for the safety and emergency features.
PQ Examples: To demonstrate that it is performing as expected in real or actual conditions to produce sterilized products. Several cycles of sterilization are conducted with real load. Verification of sterilized load for uniform sterilization, any damage or loss of efficacy.
Streamlining Pharmaceutical Equipment Validation With Customized Regulatory Support
Streamlining pharmaceutical equipment validation with regulatory compliance can be challenging. Customized regulatory support can help in avoiding failures of the qualification processes conducted. Moreover, it helps in developing more specific protocols rather than the standard ones which might not be specific to product type and requirements.
In addition, the quality of the qualifying process depends on the test plan drafted. Thoroughness and accuracy can be incorporated if an expert hand is included. At Artixio, we have a team of regulatory experts and experts in the field of medical devices. We can help you navigate smoothly through these processes. Contact us at info@artixio.com
FAQ’s
Q. What is IQ, OQ and PQ full form?
IQ stands for Installation Qualification. OQ expands to Operational Qualification and PQ expands to Performance Qualification. They are the 3 important stages in the validation of equipment.
Q. What is OQ vs PQ?
Operational qualification focuses on whether the system or equipment is operating properly. Is it doing all the functions as it is expected to perform is what is focused on OQ. In PQ, the performance qualification, it checks how the equipment or system is working in real world conditions. Is the equipment consistent and reliable over the product cycles is what is confirmed here.
Q. Why is there a need to perform IQ, OQ and PQ?
IQ, OQ and PQ are validation processes done on an equipment or system to confirm that its installation, operation and performance in the real world are consistent with the manufacturer specifications and user requirements. Moreover, it also proves that the equipment is in compliance with regulatory standards.
Q. Can we do OQ before IQ?
No, OQ is conducted only after IQ. In order to understand and check the operation of the equipment it must be installed properly. It must be made sure that there are no errors in installation and all conditions like the environmental as well as electrical and other conditions are met. This is essential for the proper functioning of the equipment.
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