In 2011, the FDA implemented a Quality by Design (QbD) pilot program to support their review and approval process. After gathering several years worth of research, the FDA decided to push forward...
Read MoreIn 2011, the FDA implemented a Quality by Design (QbD) pilot program to support their review and approval process. After gathering several years worth of research, the FDA decided to push forward...
Read MoreQuality by design (QbD) is often associated with construction projects. The idea is to develop processes that support quality throughout the construction project from planning to building to operations. In the pharmaceutical...
Read MoreIn 2009, the United States Pharmacopeia (USP) issued harmonized reference standards for the Microbiological Examination of Non-Sterile Products. While AM Life Science (AMLS) does not offer services that directly support method validation...
Read MoreCQV (Commissioning, Qualification, and Validation) is a very detail-oriented process that requires the right mix of knowledge, experience, and diligence to correctly place equipment/systems into use. Additionally, with FDA regulations and requirements...
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