IQ, OQ, PQ… we are talking Medical Device Process Validation!
Why?
Because this topic does not get as much attention as it deserves.
Insufficient Process Validation was beyond the top 3 reasons medical device companies got 483s or warning letters from the FDA in 2022. 🚨
This fact shows us that too many MedTech manufacturers approach Process Validation too lightly.
Validating your processes is a fundamental prerequisite to manufacturing safe medical devices.
However, the task of validating your processes is anything but simple.
To conduct a flawless Process Validation, it would be best to have experience and an excellent technical understanding.
In this article we raise awareness of what it takes to validate your processes properly and why this requires more than just basic technical knowledge.👇
Process Validation ensures that manufacturing processes reliably produce products that meet predetermined specifications and quality attributes [1]. It is, therefore, an important task that is (unfortunately) often underestimated.
Our blog article on Medical Device Process Validation has already addressed the most important basics you should know about Installation Qualification, Operational Qualification and Performance Qualification.
You already know what process you need to validate – not only to meet the regulatory requirements of the FDA [1] or requirements from standards like e.g., ISO 13485, but mainly to continuously produce your medical devices safely.
Having the prescribed documents and meeting the minimum requirement is one thing – but that doesn't mean your processes are efficient, deliver safe products, or save you money.
To perform flawless Process Validation, it takes above-average technical understanding and some experience. Why?
Here are 6 good reasons why your technical skills matter, especially when it comes to Process Validation.
Are you ready to validate your processes?
Why a solid technical understanding is essential for Process Validation in MedTech
1. Regulatory authorities require Process Validation & the associated technical documentation.
It is crystal clear by now: the FDA [1], but also the EMA [2] want us to validate our processes.
We must prove that the manufacturing process consistently produces medical devices that meet specifications and quality characteristics.
This is where your technical understanding is already put to the test: Do you know how to design a validation study from scratch? How do you conduct the study? And how do you interpret the results correctly? What conclusions can you draw from them?
With a solid technical understanding, you will find it easier to put the legal requirements into practice and to carry out the documentation wholly and correctly.
2. A reliable and reproducible manufacturing process requires that you are well-versed in statistical methods.
Are you an absolute statistics genius? Then you've come to the right place. Process validation loves statistics. So much so, that it can't live without statistics.
We use statistical methods to ensure the manufacturing process is reliable and reproducible.
Statistical tolerance intervals, statistical process control or process capability indices should not be foreign words to you when you are tasked with validating processes.
3. You should know how to use special equipment & tools for manufacturing.
As a medical device manufacturer, you may use advanced testing and inspection equipment to ensure your products meet the required specifications and quality standards.
Of course, to validate processes properly, you need to understand how this equipment works.
Your excellent MedTech technical understanding is required to ensure the accuracy and reliability of the Process Validation procedure [3].
Read more about Medical Device Process Validation in our previous blog posts.
4. Technical understanding is crucial to make processes efficient & effective.
One of the critical challenges in Process Validation is the need to balance efficiency and effectiveness.
On the one hand, the process validation process must be thorough and rigorous to ensure the safety and effectiveness of the medical device.
On the other hand, as a company, you should also keep the economic aspect in mind and ensure that you minimize your costs and do not lose your competitive advantage [5, 6].
This is where the wheat is separated from the chaff. Only those who deeply understand the process can also ensure that a balance between efficiency and effectiveness can occur.
5. Technology is needed to solve problems quickly and correctly.
When the manufacturing process doesn't do what it's supposed to and is anything but reliable, it's time to pull out the magnifying glass and become a detective.
Troubleshooting can be tedious and anything but easy.
This is where your technical knowledge and general understanding of the subject matter are especially challenged.
Looking for problems is part of quality management. We need to understand problems and get to the bottom of them to minimize the risk of defective products.
6. Technical understanding in MedTech is necessary to maintain the validated state of the process.
You have successfully validated the process – excellent!
The bad news is: the work doesn't stop there.
You also want to maintain the validated state of the process over time.
Changes to the process or equipment may affect performance or require revalidation.
Your technical skills are also required to develop and implement appropriate process controls and monitoring systems to ensure continued process performance.
As an absolute technical genius, you will find it easier to identify optimization opportunities and reduce unnecessary, additional testing.
Conclusion: Technical Understanding in MedTech
We mentioned a few reasons why technical understanding is so valuable in Process Validation. With this article, we want to raise awareness of the skills needed to perform a flawless Medical Device Process Validation.
Smaller companies and start-ups are sometimes unaware of the implications of poorly executed Process Validation – from lost efficiencies to the dreaded warning letters from the FDA.
As a medical device manufacturer, you want to be 100% sure that your process is validated by someone with deep technical understanding and, ideally, experience.
The devil, as is often the case, is in the details. While general knowledge is helpful, it is certainly not enough to validate your process effectively.
If you are not confident in validating your processes yet, there is nothing wrong with seeking external assistance.
SIFo Medical offers you the opportunity to network with quality experts who will work with you to validate your processes and assist you with specific questions.
Contact us at office@sifo-medical.com for further information.
PS: Do you want to learn more about Quality- and Supplier Management in MedTech? Then check out our free learning resources at our SIFo Medical YouTube Channel.
References
[1] US Food and Drug Administration. (2019). Quality System Regulation. Retrieved from https://www.fda.gov/regulatory-information/search-fda-guidance-documents/quality-system-regulation-21-cfr-part-820
[2] ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes
[3] Juran, J. M., & Gryna, F. M. (1988). Juran's quality control handbook (4th ed.). New York: McGraw-Hill.
[4] Montgomery, D. C. (2013).
[5] Renaud, J., & Diallo, S. (2003). A critical review of process validation in the medical device industry. International Journal of Quality & Reliability Management, 20(9), 969-983.
[6] Geisler, E., & Eversheim, W. (2004). Process validation in the medical device industry: A review of the current state of the art. Journal of Pharmaceutical Sciences, 93(8), 1892-1903.
[7] GMP Compliance, 19 October 2022. [Online]. Available: https://www.gmp-compliance.org/gmp-news/medical-device-warning-letter-statistics-for-fiscal-year-2022. [Accessed on 08 March 2023].
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