Life Science

AM Life Sciences (AMLS) has completed and turned over work for upgrades to a New England pharmaceutical company’s Engineering and Commissioning, Qualification, and Validation (CQV) Lifecycle program for equipment and systems. AMLS led the effort by focusing on the principles identified in ASTM 2500 (version 13) Standard Guide for Specification, Design, and Verification of Pharmaceutical […]

AM Life Science (AMLS) promotes an approach to quality by design (QbD) that we call Early Quality Integration (EQI). The goal of this process is to better support biotechnology companies meet FDA requirements. We are now partnering with a Boston-area biotech company to insert a Validation and Quality subject matter expert (SME) at the pre-construction/construction

AM Cleanroom Build and Performance (AMCBP) recently completed a cleanroom construction project for a medical device manufacturer in the Southwestern U.S. The medical device manufacturer required a compliant, safe, and efficient cleanroom to support the critical production of life-saving medical devices. A local, high-end construction company was in charge of the overall facility construction. AMCBP

AM Cleanroom Build and Performance (AMCBP) recently completed a critical assessment of a 503B compounding facility in the Southwest U.S. region. AMCBP was asked to consult on the completion of a 503B facility to assess the potential risks from the perspective of certification and clean build. Our services were vital to support the facility construction

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 with a QbD approach to evaluate the manufacturing processes used by pharmaceutical companies. The central idea is to focus on improving control in

Quality 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 industry, the U.S. FDA has taken significant steps to adopt QbD principles in their pre-market processes that guide the approval process. In fact,

CQV (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 continually changing, it is crucial to understand the CQV process to remain compliant. Before starting a CQV project on any facility, utility or

AM Life Science (AMLS) recently completed a Commissioning, Qualification, and Validation (CQV) project for a global biotechnology company. The project called for AMLS to lead a CQV team to implement disposable technology for buffer filtration and hold processes at the biotech company’s 14,000-sq. ft. pharmaceutical facility. Fortunately, AMLS already had a working relationship with the