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It is important to understand the differences between risk-based decision making and other decision making in a pharmaceutical quality system.
Validating computerized systems is required to demonstrate adherence to data integrity, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC.
Quality-by-design risk assessment workflows can be laborious and have limited capacity to connect with vast volumes of prior knowledge generated by organizations. ecosystem.
December 02, 2021
Particle analysis is a critical component of pharmaceutical development, providing assurances of the quality and performance of the final dosage form.
The need for medicines to combat COVID-19 has impacted the way regulatory agencies carry out their operations.
We have broken rules, invented new ones, and engineered stronger institutions and supply chains that will serve us better going forward.
December 01, 2021
Different methods to calculate limits for impurities will give different answers. The prediction interval method may be ideal.
November 29, 2021
The Comirnaty vaccine received a positive opinion from the EMA’s CHMP for children five to under 12 years of age.
PathoQuest is the first French contract research organization (CRO) capable of offering GMP grade NGS-based testing services for quality control of biological drugs.
November 26, 2021
Biogen received MHRA marketing authorization for VUMERITY (diroximel fumarate) for treatment of relapsing-remitting multiple sclerosis (RRMS).
November 25, 2021
The EC has granted marketing authorization for Gilead’s Trodelvy for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer.
November 19, 2021
FDA has amended its EUA for Pfizer-BioNTech’s and Moderna’s COVID-19 booster to include all individuals aged 18 or older.
Jordi Serrat, Product & Technology Director, Azbil Telstar talks about the role of disruptive and digital technologies in aseptic processing.