Commissioning & Qualification and Validation Process
Commissioning & Qualification represent the final stages in the trial operation phase. However, it is important to conduct checks at each stage from the initial design phase to maintain quality and ensure the project proceeds smoothly.
In a pharmaceutical factory…Validation (Commissioning & Qualification)
According to the GMP ordinance, “Validation” is defined as “the action of verifying that the structure, equipment, and procedures of a manufacturing site, as well as the methods of manufacturing and quality control procedures, produce the expected results, and documenting this verification.”
Achieving high-quality and efficient validation in new construction or renovation projects of pharmaceutical factories is one of the most important tasks to accomplish.
Validation Support by CM Plus
CM Plus possesses “Validation Management Technology,” which enables efficient validation through a consistent philosophy from the initial stages of the project.
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Related Contents
Useful Information
Please also refer to the articles on our information dissemination site, “GMP Platform.” Although the title contains “Pharmaceutical Factory Construction,” the content is applicable to the construction of factories in various industries, not limited to pharmaceutical factories.
“How to Build a Pharmaceutical Plant”
This article discusses how to minimize the burden of validation, which requires substantial time and cost in pharmaceutical factory construction projects, while achieving both GMP compliance and cost rationality in the deployment of qualification. We propose the concept of Lean Qualification. More details can be found in the article “Know-how for Pharmaceutical Factory Construction” on our information dissemination site, “GMP Platform.”
