Basic Introduction of Equipment Development & Qualification
The objective of validation is to provide the evidence that the process can consistently and reproducibly produce parts which can meet the predetermined acceptance criteria. The validation activities shall be adjusted in accordance with relevant inputs (e.g. scientific evidence, risk-based evaluation). The Equipment Qualification is a package of test results and it could be part of validation source which depends on the scope of Equipment Qualification.
Here is a general equipment development process shown in Figure 1.
This is a general structure to show the process flow and some of the items may be adjusted depending on the project’s arrangement due to the balance between product quality and business requirement.
For example, the dotted line in Figure 1 may not be conducted due to the qualification approach.
Another interesting thing is that the quality control concept has adjusted from Quality by Test (QbT) to Quality by Design (QbD) in recent decades. From QbD point of view, the specific requirements corresponding to the intended use are the most important things at the beginning of development phase which give us a guidance on how equipment is designed and where the risks come from. Therefore, the qualification/ validation approach can be established on these requirements and risks.
In summary, the overall qualification approach is adjusted with the time. No matter how the qualification approach changes, the objective is the same. It is a method that how to achieve the quality.
Here we only talk about initial Equipment Development/ Qualification/ Validation which is only a small part of product life cycle.
Continued Process Verification is another interesting topic through product life cycle.
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