Quality Systems

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

Articles

High price tags threaten to block patient access to potentially life-saving cures and treatments.

FDA Grapples with the Promise and Perils of Gene Therapy

While supply chain disruptions have resulted in many alterations to workplace practices, they have also presented an opportunity to get ahead of changes to the EU’s upcoming revision of Annex 1.

Looking Past the Pandemic: The Future of GMPs in Aseptic Processing

The new General Chapter <1469> “Nitrosamines Impurities” by USP became official on Dec. 2, 2021, in the United States Pharmacopeia—National Formulary. 

USP’s Nitrosamine Impurity Standard is Now Official

EMA has fully validated the marketing authorization application for Atara Biotherapeutics’ off-the-shelf allogeneic T-cell therapy, tab-cel (tabelecleucel), with an approval decision expected in 2022.

Atara Biotherapeutics' MAA for Allogeneic T-cell Immunotherapy Gets EMA Validation

The need for medicines to combat COVID-19 has impacted the way regulatory agencies carry out their operations.

Pandemic Alters Policies and Practices for Drug Development and Regulation

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, answers some commonly asked questions about the difference between the roles of quality assurance and quality control.

Frequently Asked Questions About Quality Control vs. Quality Assurance

Chris Burgess, PhD, is an analytical scientist at Burgess Analytical Consultancy Limited, ‘Rose Rae,’ The Lendings, Startforth, Barnard Castle, Co Durham, DL12 9AB, UK; Tel: +44 1833 637 446; chris@burgessconsultancy.com; www.burgessconsultancy.co

Different methods to calculate limits for impurities will give different answers. The prediction interval method may be ideal.

From PharmTech: Detecting and Determining Quantitation Limits for Impurities

The Comirnaty vaccine received a positive opinion from the EMA’s CHMP for children five to under 12 years of age. 

EMA Recommends Pfizer and BioNTech’s COVID-19 Vaccine for Children 

PathoQuest is the first French contract research organization (CRO) capable of offering GMP grade NGS-based testing services for quality control of biological drugs.

PathoQuest Achieves GMP Certification for Quality Control Testing Services

Biogen received MHRA marketing authorization for VUMERITY (diroximel fumarate) for treatment of relapsing-remitting multiple sclerosis (RRMS).

Regulatory Oversight and Compliance