A well-chosen replication strategy can effectively reduce uncertainty.

Reducing Uncertainty of an Analytical Method 

Nitrosamine contamination triggers a  slew of solid-dose drug recalls.

Industry Contends with Contamination-Based Recalls

With the proper technology, remote auditing can be effective.

Conducting Effective Audits

Simulation compares statistical techniques used to determine out-of-trend events.

Determining Out-of-Trend Stability Test Results

Topic

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

Articles

Patrizia Cavazzoni will become the director of the Center for Drug Evaluation and Research, and Janet Woodcock remains in limbo as the temporary head of FDA.

Leadership Change at CDER Spotlights Imperative to Name New FDA Commissioner

CDC and FDA are reviewing data from reported cases of a rare type of blood clot in people that received the Johnson & Johnson COVID-19 vaccine. 

FDA Recommends Pausing Use of J&J COVID-19 Vaccine After Reports of Blood Clots 

Even before Emergent disclosed that it had to discard 15 million doses of the J&J vaccine drug substance, FDA inspectors had uncovered multiple deficiencies and quality control issues.

FDA Inspectors Cited Critical Problems at Emergent Facility

Editor of Pharmaceutical Technology Europe

Accelerated formulation strategies are a useful tool to reduce development timelines and cost, but key priorities must be considered early on to ensure success.

Focusing on Accelerated Formulation Strategies

Richard Denk is Head Sales Containment at SKAN AG, www.skan.ch, Richard.Denk@skan.ch.

Decontamination, automation, and containment are important considerations
for aseptic manufacturing in isolators.


Understanding the Impact of Annex 1 on Isolator Operation

Phil Borman, DSc, has served in multiple quality-related roles at GlaxoSmithKline; as of April 2021, he is senior fellow and director of product quality.

Timothy Schofield is owner and consultant, CMC Sciences, LLC;

David Lansky, PhD, is president, Precision Bioassay, Inc.

A well-chosen replication strategy can effectively reduce the uncertainty for an analytical method, enabling appropriate decisions regarding pharmaceutical quality. 

Reducing Uncertainty of an Analytical Method through Efficient Use of Replication

After Brexit there is an increased risk of the UK being exposed to counterfeit medicines, but regulations implementing blockchain as infrastructure technology could be the answer.

Blocking the Threat of Counterfeit Medicines

Concerns over vulnerability in the supply chain has increased pressure on FDA to renew site visits of domestic and foreign facilities. 

Pressure Mounts for FDA to Ramp Up Drug Inspections

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

Steven J. Lynn is executive vice-president, Pharmaceuticals for Regulatory Compliance Associates, Inc.

Experts Steven J. Lynn, executive vice-president, Pharmaceuticals for Regulatory Compliance Associates, Inc., and Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, Inc., provide simple answers to frequently asked questions regarding deviation investigations.

Frequently Asked Questions on Deviations

The White House’s American Jobs Plan includes investment in new technologies for rapid scale up of vaccine production, in expanded emergency production capacity and enhanced US infrastructure for biopreparedness, and in greater production onshore of APIs.   

Quality Systems

Reducing Uncertainty of an Analytical Method

Industry Contends with Contamination-Based Recalls

Conducting Effective Audits

Determining Out-of-Trend Stability Test Results