A pharmaceutical quality crisis involving nitrosamine contamination began in 2018 with the discovery of ...
Piramal’s latest FDA reprimand comes after the company disclosed the receipt of a separate Form 483 at its API facility in Michigan last February. (hudiemm/iStock/Getty Images Plus) Roughly a year ...
With the publication of ICH Q2(R2) and ICH Q14, the modern Quality by Design (QbD) paradigm introduced by ICH Q8 for manufacturing has now been extended to Quality Control (QC). A life cycle and ...
WEST LAFAYETTE, Ind. — International process systems and operation experts have launched high-tech startup Crystallization Systems Technology Inc. (CrySyst) to streamline processes used by companies ...
Analytical tasks in the pharmaceutical industry range from drug discovery to production and quality control for consumer product. This entire process is subject to a variety of laws and regulations ...
The pharmaceutical industry’s approach to data integrity has been historically manual, leveraging physical documentation and potentially unreliable paper-based ...
The growth highlights the company’s strong foundation built on quality products, strategic vision and operational excellence.
Atal Bansal is the Founder and CEO at Chetu, a global U.S.-based custom software solutions and support services provider. For centuries, quality control inspection has been time-consuming and ...
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