Quality/GMPs

Articles

Connect with pharmaceutical and healthcare regulatory authorities around the world via this directory.

Regulatory and Standard Setting Organizations

The agency sent an open letter to European Ombudsman Emily O’Reilly affirming the agency’s intention to apply the same standards to the evaluation of COVID-19 treatments as it does to other medicines.

EMA Confirms Standards for COVID-19 Treatment Evaluations

Automation, digitalization, and supply-chain strategies help mitigate vulnerabilities in both autologous and allogeneic cell therapy manufacturing.

Navigating Cell Therapy Manufacturing Amid Pandemic Woes

Fill/finish inspection for vaccine vials and syringes must remain GMP-compliant while aiming for fast, efficient methods.

Reconfiguring Fill/Finish Inspection to Meet COVID-19 Vaccine Goals

Best practices to consider when transitioning from research-grade to GMP-grade materials. 

Avoiding the GMP Bottleneck

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

Drug shortages and supply chain challenges bolster FDA efforts to promote modern manufacturing.

Will COVID-19 Pandemic Finally Establish Drug Quality Metrics?

Telstar has reinforced its consultancy service to aid pharmaceutical companies in the compliance of the latest version of the EU GMP Annex 1 guidance.

Telstar Reinforces Consultancy Service in Accordance with New Annex 1

ISPE has released new guidance on the cleaning validation lifecycle, written by a group of experts and reviewed by regulators and practitioners.

ISPE Releases Cleaning Validation Guide

Fears about overly accelerated development programs has heightened demands for wider access to information on study protocols, statistical analysis plans, and early results.

COVID-19 Vaccine Concerns Prompt Clinical Trial Transparency

The guidance document offers information on the placement and content of geriatric information in labeling of drugs and biologics.

Regulatory/GMP Compliance