Medical Electronics
sequence of execution must be clarified, including requirements for re-validation. Procedures for process validation should also contain further details regarding testing, training, documentation, review and approval.
Manufacturers often choose to develop a Validation Master Plan (VMP) as a tool to control and monitor the status of validation activities. As VMPs are not required by regulations, the content and structure can vary widely.
An individual validation plan is another tool that is widely used to support the planning for more complex projects such as new manufacturing lines or production transfers. The individual validation plan may establish a generic validation strategy and offer the potential to approach validation activities in a more structured manner.
Equipment qualification Equipment qualification (EQ) adds value for manufacturers by helping to prevent future issues. When done properly, it ensures that equipment operates in a reliable and predictable manner. All equipment and machines used in the
manufacturing process of medical devices require EQ. It supports manufacturers in properly establishing key areas of operation such as maintenance plans, calibration tolerances and intervals, as well as cleaning or microbiological procedures.
Recommendations or instructions from third-party equipment suppliers are an essential source of information and must be considered during installation activities. Applicable support systems and utilities must also be verified and completed during installation. This extends beyond the supply of electricity and compressed air to encompass other topics such as material supply or data transfer infrastructure. Functional testing of the equipment, including alarm and control systems, must also be carried out. Furthermore, operating instructions for the equipment and training documentation needs to be prepared accordingly. Any documentation such as manuals, drawings or codes that are needed to operate, maintain or repair the equipment should be compiled and retained for future use. Validation is also needed to provide objective evidence that computerised systems and software tools
are suitable for their intended purpose
Operational qualification An operational qualification (OQ) is usually accomplished in two main steps: 1. Identification of critical process parameters 2. Provision of evidence that production at worst-case settings will still result in a product that meets specifications
Once OQ samples are tested, results are recorded and evaluated thoroughly, including statistical analyses. In most cases, OQ should be successfully completed as a prerequisite before starting Performance Qualification.
Performance qualification In order to determine the scope, range and size of the performance qualification (PQ), it is vital to understand the natural process variability and other influences that routine manufacturing may be exposed to. The PQ plan should therefore clearly describe how many routine manufacturing runs are required to show repeatability and stability of the processes under consideration. Additionally, sampling plans need statistically sound justifications. Successful completion
of the PQ will enable the manufacturer to initiate approval of the new or changed manufacturing process.
Once the manufacturing process has been validated, it is a requirement to maintain the validated state. This entails monitoring and controlling validated process parameters to ensure that the specified requirements continue to be met. The application of statistically sound sampling plans is a requirement of ISO 13485, and manufacturers are responsible for determining and justifying them. However, these plans will not replace proper process development or monitoring of critical process parameters. The Global Harmonization Task Force (GHTF) guidance SG3/N99-10:2004 (ed.2) defines process validation as ‘a term used in the medical device industry to indicate that a process has been subject to such scrutiny that the result of the process … can be practically guaranteed’. Technical understanding of the manufacturing processes is therefore key to ensure that the process results ‘can be practically guaranteed’.
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Components in Electronics
October 2023 37
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