By Maria Wik, MS VP, CMC Development The ICH Q10 definition for a Control Strategy is: “A planned set of controls, derived from current product and process understanding, that assures process performance and product quality.” Understanding the essence of a process...
Biomedical startups experience a failure rate of 90% per year for various reasons, including flawed financial strategies, inexperienced management, subpar science, poor timing, and an aversion to risk. Another significant factor is quality control issues stemming from...
Personalized medicine is truly that. Based on an individual’s unique genetic profile, it’s used to make precise decisions according to that person’s biologically predetermined factors, and guides the optimum approach to disease prevention, diagnosis, and...
Certain key strategies are imperative for establishing effective quality control (QC) systems in the development of new pharmaceuticals. The “Key 3” are implementing a QC process control strategy, creating a Standard Operating Procedure (SOP) manual, and partnering...
One thing that we on the Technical and Quality Assurance (QA) QA team share with every employee throughout Syner-G is intelligence, passion, and unwavering commitment to making a difference. While every department within the organization brings unique knowledge and...
How AI and ML can facilitate quality improvements in biopharma Artificial Intelligence (AI) and Machine Learning (ML) are often confused, but they are fundamentally different. AI comprises pre-built products that use established patterns for recognition and...
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