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In the world of medical device manufacturing, maintaining a validated state for your manufacturing processes is crucial to ensuring product quality and regulatory compliance.
This article discusses when processes need to be revalidated and when certain validation steps could potentially be skipped.
Learn more about revalidation in the video, which is an excerpt from industry expert Helena Hjälmefjord’s online course on process validation for medical devices.
Once you have validated your processes, you need to ensure they maintain a validated state. You do this by monitoring trends to ensure that they stay within established parameters. The data monitored should be related to the predefined quality characteristics of the product or process.
The collection of data is done in accordance with the documented quality plan and should be continuously reviewed by the appropriate persons in the company. ISO 13485:2016, the standard for quality management systems (QMS) specific to medical devices outlines requirements for the monitoring of data.
The standard emphasises the need to collect and analyse data to ensure that the QMS is functioning effectively. This includes data related to product and process performance, and it requires that this data is reviewed at management reviews.
The quality plan should define the critical quality parameters for the process and product, the schedule for data collection as well as the target value, upper and lower control limits, upper and lower acceptable limits for each parameter, as well as monitoring methods.
One common way to monitor data is using a control chart. With this method, data is collected in accordance with the quality plan, plotted in a control chart, and trends are followed.
The control chart shows the target value (green line), the upper and lower control limits (yellow lines), as well as the upper and lower acceptable limits (red line). By monitoring these attributes and following the trends, you can identify when there is a negative trend.
When you see a negative trend, you need to investigate the cause and take corrective actions if necessary. This could be that the manufacturing process needs to be adjusted and revalidated.
Several conditions can trigger the need to revalidate a process; some might not be immediately obvious. For example, changes in environmental temperature and humidity, or changes made to materials by suppliers can cause shifts in the trends.
Monitoring a manufacturing process facilitates identifying when the process changes or when something impacts the process output. Hopefully, this will allow you to correct the issue before the product is released to the customer.
Changes to product design, materials, or parts, as well as modifications to the manufacturing process, may require validation or revalidation of the manufacturing process.
Each change you make to a device or manufacturing process should be reviewed to identify if it impacts the safety and quality of the product, and if the manufacturing process, or parts of the process, need to be revalidated. This should be included as a routine review in the company’s change control and risk management procedures.
Revalidation of a process may also be needed if the application of the process is changed, for example, you want to manufacture other products using the same equipment.
If a company decides to move the production of a product from one company site to another site or outsource it to another company, then revalidation is required even if no changes are made to the manufacturing process, environment, equipment, product, or resources at the new site.
External factors can also require the need for revalidation. This could be that regulatory requirements or standards are changed, and the changes affect the products or processes.
When a change is made to a regulation or a standard, these changes should be reviewed to see if they have an impact on the product or process. The review, and the conclusion of the review should be documented.
Some standards state how often certain manufacturing processes should be revalidated. This is typical for standards related to, for example, sterilisation.
Since the sterilisation process is critical to the safety of the device, it needs to be revalidated on a regular basis even of there is no negative trend or any changes are made.
These types of revalidations are referred to as planned validations and should be documented in the master validation plan.
If you establish that a process requires revalidation, it might not be necessary to repeat every step of the original validation. The decision to pursue revalidation, as well as the reasoning behind which steps to include or not include, should be thoroughly assessed and documented.
There are also other situations when not all validation steps are required. For example, when you purchase new equipment identical to what is already used in the same production line. You will still need a user requirement specification (URS) outlining the equipment requirements. However, you might already have a valid URS from previous equipment that can be used or updated.
In this instance, you will need to perform an installation qualification (IQ) for the new equipment. However, if the new equipment doesn’t affect critical parameters and is identical to the equipment already used; you have already defined the parameters and could therefore skip the operational qualification (OQ).
The performance qualification (PQ) will need to be repeated to provide objective evidence that the process, under anticipated conditions, consistently produces a product which meets all predetermined requirements. Finally, you will need to update the final report with references to the new documentation and the review of the conclusion, as well as the master validation report.
Another example where you may not need to go through each validation step is when changes are made to materials. Since there is no new equipment involved, you will not need a URS or an IQ. However, you might still need to perform parts of the OQ to define new manufacturing parameters, and the PQ needs to be performed to ensure that the process consistently produces a product that meets all predetermined requirements under the expected conditions. This is also applicable if suppliers change the composition of the material or parts used.
For example, when the Tyvek supplier changed the composition of some of their materials a few years ago, each manufacturer using these materials in their products had to revalidate their processes to ensure their parameters still provided an acceptable sterile barrier even though the supplier had done extensive testing.
The need for revalidation should be carefully evaluated and documented.
The documentation should include the reason for the review, such as examining quality indicators, changes to the process or design, or updates to external requirements. It should also detail the analysis performed and the conclusions reached, even if the decision is to not revalidate.
Validation, monitoring of the validated status, and when required, revalidation of the process, is an ongoing process from early in the product development until the medical device is no longer manufactured. The purpose of this work is to ensure a process consistently produces results or products that meet predetermined requirements, leading to safe products and satisfied customers.
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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