It is important to understand the differences between risk-based decision making and other decision making in a pharmaceutical quality system.

Steps Towards Demystifying Risk-Based Decision Making

Validating computerized systems is required to demonstrate adherence to data integrity, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC.

Computer Validation Confirms Evidence

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.

Digitalization of QbD Risk Assessments

Topic

Articles

Takeda’s dengue vaccine is designed to prevent disease caused by virus serotypes 1, 2, 3, and 4 in individuals four and older.

EMA Announces Positive Indication for Takeda’s Dengue Vaccine

Felicity Thomas is Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Podcasts

In this episode, Ana Ladino provides expert insight into novel excipients in the current and future drug development landscape.

Drug Solutions Podcast: Novel Excipients in Drug Development

Aloka Srinivasan, PhD, is Principal and Managing Partner, Raaha LLC.

Chuck Lambert, PhD, DABT, ERT is principal toxicologist at Intrinsik Ltd.

The authors discuss the differences in mechanism of activation of N-nitrosamides versus N-nitrosamines and the fact that they should not be treated the same.

Nitrosamides–Should They Be Treated the Same as Nitrosamines?

FDA amended its authorization for the Moderna and Pfizer-BioNTech bivalent booster vaccines to permit their use in children as young as five years old.

FDA Authorizes Bivalent COVID-19 Boosters for Children Ages Five and Older

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

CBER maps modernization plan to handle surge in research and applications. 

FDA Expands Oversight of Cell and Gene Therapies

The UK’s MHRA has approved Colonis’ melatonin oral solution for sleep onset insomnia in children and adolescents with ADHD.

UK Approves Treatment for Sleep Onset Insomnia in Children and Adolescents

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Production of viral vectors requires a holistic view of the product, including its manufacturing process and its ultimate end use.

Testing for Adventitious Agents in Viral Vector Production

FDA has granted Fast Track designation for CUE-101, a treatment of recurrent/metastatic head and neck squamous cell carcinoma. 

FDA Grants Fast Track Designation to Cue Biopharma

Pramote Cholayudth previously was the managing director of the Professional Conference Center, Ltd. He currently is a validation consultant to Biolab Co., Ltd., in Thailand. He is the founder and manager of PM consult, cpramote2000@yahoo.com.

This article introduces a control chart technique using F statistic for continued process verification of oral solid dosage forms.

Application of F Charts in Continued Process Verification of OSD Forms

Joseph A. Albanese, director of Analytical Strategy and Compliance at Janssen Research and Development, LLC

J. Mark Wiggins is owner and compendial consultant with Global Pharmacopoeia Solutions LLC.

Awareness of recently implemented—or ongoing—advances by the pharmacopoeias can help biotherapeutic manufacturers remain compliant with current requirements.

Quality Systems

Steps Towards Demystifying Risk-Based Decision Making

Computer Validation Confirms Evidence

Digitalization of QbD Risk Assessments