Medical Device- Process Validation in QMS
“Establish by objective evidence that a process consistently produces a result or product meeting its predetermined requirements.” – Process Validation
This is described by Global Harmonization Task Force (GHTF), which was a voluntary group of representatives from national medical device regulatory authorities and the regulated industry.
It is interesting about the wording of objective evidence, consistently, and predetermined requirement.
Documentation with risk-based evaluation & scientific results (e.g. critical variable control, test data, procedure…etc.)
Test results evaluation by scientific results & statistical analysis
Intended use & acceptance criteria
Since the Process Validation is required in Medical Device industry to provide a high degree of assurance about the product before production, it is exactly a milestone of a product within product life cycle. That is, we could lunch our products after finishing Process Validation.
In order to meet the regulatory requirements and provide the evidence of the manufacturing process, we look into the product life cycle. The efforts we need to put to obtain the objective evidence for Process Validation is simplified in Figure 1 below.
As shown in Figure 1, it is interesting that when we start to collect the objective evidence and whether it is sufficient. This is always a critical topic for each manufacturing process.
From Figure 1, the verification and validation activities (e.g. Equipment Qualification & Process Validaiton) could be estimated and conducted evenly during the new product introduction (NPI) phase based on the assumption that all requirements have been listed in the beginning of planning phase. Therefore, we will have a smooth NPI progress and move forward to production. However, we could say this is an ideal case that we want to achieve. It must puts lots of efforts on it, but hard to control everything in the end. For most of cases, we may face many limitations or unexpected issues during NPI phase.
Once we start to document the experiment results, we need to make sure all test results are recorded and manage all changes including risk management.
What a great effort on documentation!
As a result, Process Validation is generally conducted separately and sometimes looks like an exam of this manufacturing process to prevent some ineffective works.
Overall, the Process Validation is focus on design and development control, quality assurance, process control, and corrective and preventive action, which is aiming at obtaining a high-quality product. All these elements shall be considered and summarized into validation documents, which shall be designed based on the process understanding.
The regulation only describes a framework of Process Validation. Process Validation is part of the integrated requirements of a quality management system, which is sourced from GHTF. The detailed practice/ documentation about Process Validation will depend on each company’s policy and shall be auditable per regulatory requirement.
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