Selvaraja Elumalai – distinguished quality control professionals with an experience of more than twenty years in the pharmaceutical industry. He has a solid foundation in physical chemistry and is ...

QC laboratories perform a critical role in demonstrating pharmaceutical products are consistently manufactured, safe, potent, and pure. At the same time, the number of tests run by QC laboratories is ...

AMRI announced today that Tom McGrath has joined the company as Director, Quality for Aseptic Services at AMRI's Burlington, Mass. site, reporting to Junan Guo, Ph.D., Senior Director, Pharmaceutical ...

Gas analysis is a crucial aspect of pharmaceutical quality control, which plays a significant role in ensuring the safety and efficacy of drugs. This article discusses the role of gas analysis in ...

In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, ...

Biopharma quality control is being revolutionized by advanced analytics and digital transformation through a synergy that boosts quality and scalability.

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 quality control refers to all those processes and procedures designed to ensure that the results of laboratory analysis are consistent, comparable, accurate and within specified limits.

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 ...

Support from the FDA, industry groups and automation suppliers is helping pharmaceutical companies break the batch habit in favor of a continuous approach to drug production. In November 2016, ...