By James Lin, Project & Validation Engineer, Bora Pharmaceuticals
Equipment qualification is critical in the pharmaceutical industry. The equipment not only includes manufacturing equipment but testing and sampling equipment also to name a few. Even the slightest error or misuse can pose a costly risk and time delay for the pharmaceutical product owner and their manufacturer. So, what is equipment qualification? It is a series of inspections, tests, and assessments to ensure that a given piece of equipment is compliant and ensures reliable performance. Equipment validation is required to prove that a given piece of equipment does, on a consistent basis, what it is supposed to do. As a key component of quality assurance, equipment qualification is critical to consistently producing high-quality products.