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Working with medical devices usually means compiling a lot of documentation. This article lists key documents and records in process validation for medical devices, including:
Understanding the terminology behind these validation documents is essential for navigating the complexities of process validation and meeting regulatory standards.
Learn more about the process validation in Helena Hjälmefjord’s online course Process Validation for Medical Devices.
The master validation plan, or MVP, defines the manufacturing and process flow of the products or parts that the organisation manufactures. It also identifies which processes need to be validated, schedules the validation, as well as the interrelationships between the processes.
In summary, the MVP outlines the overall strategy and approach for the process validation activities.
There could be one MVP for all manufacturing processes and products in an organisation, or one per device or process. How you do this is up to your organisation to decide.
Once it has been decided that a piece of equipment or a process needs to be validated, all the requirements should be documented in a user requirement specification, or a URS.
The term “user requirement specification” is sometimes confused with user needs, but they refer to different concepts. The URS is specifically related to production, while user needs focus on the design and development of a product.
The URS addresses the question, “Which requirements do the equipment and process need to fulfil?”. In contrast, user needs seek to answer, “What do users need?”
In most cases, there is more than one process that requires validation in a manufacturing process, so you will likely have more than one URS.
The aim of the installation qualification (IQ) is to ensure that the equipment used for manufacturing medical devices is installed and functions correctly according to both your requirements and the supplier’s instructions. An IQ is necessary when new equipment is installed or when existing equipment is repurposed for a different manufacturing process or intended use beyond what was covered in the initial IQ.
The process involves describing the necessary steps, which are documented in the installation qualification protocol (IQP). Once the protocol is completed, it is signed to confirm that it is both complete and correct.
If you have several pieces of equipment to install, you will have one IQP for each of them.
Once the equipment has been installed correctly, the operational qualification, the OQ, can be performed. The aim of the OQ is to establish and confirm the process parameters that will be used to manufacture the medical device.
The operational qualification is planned out in the operational qualification protocol, the OQP. The OQP summarises the data and results and provides a conclusion for the OQ.
Once completed, the OQP is signed to ensure that it is complete and correct.
Next up is the performance qualification, the PQ. The key objective of the PQ is to demonstrate that the process will consistently produce acceptable products under defined conditions.
As with the previous steps, you plan the work for the performance qualification in the performance qualification protocol, the PQP.
Once completed, the PQP is signed to ensure that it is complete and correct.
You have now performed all activities in the validation of equipment, system, or process.
At the end of the validation activities, a final report should be prepared. This report summarises and references all the protocols and results and provides conclusions on the validation status of the process.
The final report should then be reviewed and approved following your organisation’s procedures, typically by representatives from the validation team and relevant management.
The final report is the document that provides an overview and traceability to all the documentation produced in the validation and it should be the first document you show auditors when they want to review a process validation.
You have now completed the validation of our process, generated extensive documentation, and summarised everything in the final report, along with a conclusion on the validation status.
Lastly, it’s time for the master validation report, the MVR. The MVR aligns with the master validation plan and provides a summary of all the process validations conducted for the manufacturing of a medical device. It references the final report for each completed validation.
In many companies, the MVR and MVP are combined into a single document called the MVP.
There are exceptions when you do not need to go through every step of the validation process and generate this amount of documentation.
Let us use a label printer as an example.
You would need a short URS that describes the printer’s requirements. You would then plan the installation qualification in the IQP, install the printer, print a predefined number of labels, and document it all in the IQ protocol.
If there are no settings or parameters on the printer that can be changed, or environmental aspects that can affect the output from the printer, it may not be necessary to perform an operational qualification. This means that you can go straight to the performance qualification.
You plan the work in the PQP, let different operators during various shifts print labels in accordance with the approved instructions, and document the results.
A final report will then reference the applicable documents and conclude the status of the validation. And finally, the MVR is updated with a reference to the final report, and a status of the validation.
Even though process validation often takes considerable time and effort and can lead to a lot of documentation, it’s important to remember that this work is incredibly valuable.
Process validation is essential not just for ensuring that your process consistently produces products that meet the required specifications but for complying with regulations. It also provides solid evidence for audits and helps you identify key process parameters to monitor, offering valuable data to improve your manufacturing over time. Read more about when to perform process validation for medical device processes in our guide.
Learn about key validation techniques, how to avoid common pitfalls, which processes need validation, and how to maintain a validated state and much more with industry expert Helena Hjärmefjord in our online Process Validation for Medical Devices course.
This practical self-paced online course is suitable for anyone involved in product development, design transfer, and manufacturing of medical devices, as well as quality assurance personnel.
Helena Hjälmefjord has extensive experience within the medical device industry, Class I to Class III devices, and In-Vitro diagnostics; as well as with allografts (human tissue). Amongst others, she has worked as project leader, quality manager as well as design control and regulatory assurance lead. Helena has worked in both small companies as well as large international companies. Since 2014 she works through her own consultant company, Fjord Consulting.
Helena’s motivation is getting customers to understand the importance and benefits of the regulations that are placed on their medical device products and related processes.
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