Quality Systems

Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.

Articles

System documentation should include a system description, history, validation information, and references, according to Siegfried Schmitt, Vice President, Technical at Parexel.

Computerized System Descriptions–How Hard Can It Be?

Waters and Genovis will work to develop automated workflows for the fast and constant characterization of critical quality attributes of monoclonal antibodies and other protein-based drugs in bioprocess development, formulation, stability testing, and quality control.

Waters and Genovis to Collaborate on Biopharmaceutical Characterization Workflows

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

A FDA report cites multiple ongoing violations that undermine assurance of quality in products from this plant and the need for a continuing “pause” in production.

FDA Unveils Extensive Manufacturing Violations at Emergent

This new technology could eliminate the need for cold chain storage, transport, and distribution of temperature-sensitive molecules.

Hyalo Technologies Unveils Room Temperature Drug-Stabilizing Technology

Kalah Auchincloss, senior vice-president and deputy general counsel, Greenleaf Health, Inc.

This article explores the evolution of FDA’s approach to inspections of drug and biologics manufacturing facilities during the COVID-19 pandemic.

FDA Inspections During COVID-19: A Brave New World

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

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

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

Rena Verma is a Senior Managing Director in FTI Technology’s Information Governance, Privacy and Security Practice. Rena has been providing advisory solutions to Fortune 500 legal departments and law firms in information governance, electronic discovery, legal technology and legal operations for nearly two decades. Rena's clients include some of the largest pharmaceuticals companies, banks, insurance, transportation and technology companies.

To maintain business continuity and employee safety during the pandemic, many companies have begun tracking and maintaining records of employee health information.

Privacy and COVID-19 Clash, Creating Unprecedented Risks for Pharma

Saroj Ramdas is GSK fellow and director, CMC regulatory strategy and advocacy with GlaxoSmithKline.

Renata Varga is principal scientist, Teva Branded Pharmaceutical Products R&D, Inc.

Martin Gastens is senior director program management, AbbVie Deutschland GmbH & Co. KG.

Twinkle R. Christian is process development scientist, Bharat Jagannathan is process development senior scientist at Amgen.

Bharat Jagannathan is process development senior scientist at Amgen.

Barbara Rellahan, rellahan@amgen.com, is director, product quality at Amgen.

Jillian Brady is manager, science, regulation & policy, Faegre Drinker Biddle & Reath LLP.

Many biologic drug manufacturers encounter similiar challenges; precompetitive collaboration can help resolve these issues. Representatives of the IQ Consortium’s Biologics CMC Leadership Group describe efforts to address the safe handling of biologic drugs in closed-system transfer devices in healthcare settings and the need for phase-appropriate specifications.

Quality Assurance/Quality Control