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This article discusses when process validation needs to be performed for medical devices, both during the development of the device and in production. It also highlights the importance of validating manufacturing processes after changes to equipment, design, or production environments.
If you would like to expand your knowledge on this topic, do not miss Helena Hjälmefjord’s online course on process validation for medical devices.
The schematic presentation below shows the different phases that are typically included in the design and development of a medical device.
Design transfer is where the design results are translated into manufacturing specifications and production is set up. This is, typically, when we perform process validation of any involved manufacturing processes.
The terminology “design transfer” may have different meanings in different companies. In accordance to FDAs 21 CFR Part 820.30(h) the definition of design transfer is:
“Each manufacturer shall establish and maintain procedures to ensure that the device design is correctly translated into production specifications.”
In other words, Design transfer is the process of converting a device’s design into a finished manufactured product.
Process validation should not only take place during the development of a medical device and when setting up production. It should also take place after placing the medical device on the market, and there are three main situations for that.
When changes are made to an existing manufacturing process, the process must be reviewed to see if the changes require the process to be validated or revalidated. This could, for example, be if equipment is changed or production is moved.
A justification for not performing revalidation should be documented.
If there is a change in the device design that leads to a new manufacturing process or if the existing process is affected, it becomes necessary to review whether these changes require the manufacturing process to be validated or revalidated.
This consideration includes, but is not limited to, changes in the design or the materials used.
Validation and revalidation is an ongoing process from early in the product development until the medical device is no longer manufactured. Certain processes require planned revalidations at regular intervals.
For example, the master validation plan might state that a particular process with relatively high risk should be revalidated annually, whereas a process with low criticality might be revalidated much more rarely.
The Global Harmonization Task Force (GHTF) guideline has a helpful flowchart to determine if a medical device manufacturing process must be validated or not.
Step A: First, you need to establish a specification for each process that includes both the process parameters and the desired output. This is usually documented in a user requirement specification (URS). After that, you need to evaluate if the output can be verified through monitoring or measurement.
For example, if the length of a part is a required output, can you measure each part? Or, if the appearance of a part is critical, can you visually inspect it to ensure the part meets the requirement?
Step B: If the answer is yes, you should consider whether verification is sufficient to eliminate any unacceptable risk and if it is cost-effective. This is where knowledge about the ISO 14971 standard and risk management comes in handy!
Step C: If the answer to this question is yes, you can verify the output and manage the process accordingly. Remember to document the discussion and conclusion from each step.
Step D: If the answer to A and B is no, meaning that you cannot verify the output, or you choose not to verify the output, you have to validate the process.
Step E: Alternatively, you might find that the product or process needs to be redesigned to reduce variation and improve quality. You might, for example, decide to attach two parts to each other using a screw instead of glueing them together, the latter which would have required process validation.
Keep in mind that any change in the manufacturing process might require process validation, even if the process only needed verification and control before.
In conclusion, process validation is essential for ensuring that the manufacturing process consistently produces products that meet predetermined requirements. Additionally, effective process validation contributes to improved product quality in the market, which ultimately increases customer satisfaction.
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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