Quality Systems

Bianca Piachaud-Moustakis is lead writer at Pharmavision, Pharmavision.co.uk.

Articles

Under the revised NIS-2 Directive in Europe, pharma companies will need to be proactive in safeguarding their digital assets.

Securing Europe’s Critical Entities from Cyber Attacks

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

FDA backs joint reviews, common research policies, and modern production methods around the world.

Advancing Global Collaboration for Drug Testing, Regulation, and Manufacturing

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, addresses the difference between regulatory compliance and real compliance.

Regulatory Compliance Versus Real Compliance

Detlev Lennartz, Sample Handling Product Manager, Thermo Fisher Scientific.

Choosing low-adsorption glass vials helps ensure detection accuracy.

High-Quality Glass Improves Confidence in Analytes Measurement

Julie Lippke, analytical research and development at Pfizer Inc., Groton, CT

Joseph Mongillo, analytical research and development at Pfizer Inc., Groton, CT

Thomas Cullen, analytical research and development, AbbVie Inc., North Chicago, IL

Christian Metz works in Analytical Research and Development at AbbVie Inc., Ludwigshafen, Germany.

Katria Harasewych, quality, Merck & Co., Inc., Kenilworth, NJ

Fouad Benamira works in Analytical Development Sciences for Biologicals at UCB S.A. Belgium.

The IQ Working Group has defined a pragmatic risk-based approach to audit trail review, where it is only required for high impact GxP data.

A Harmonized Approach to Performing a Risk-Based Audit Trail Review

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

A process flow diagram can help create an agreed-upon process flow for a third-party standard operating procedure, says Siegfried Schmitt, VP Technical at Parexel. 

Best Practices for Developing a Third-Party Auditing SOP

Pharmaceutical Technology spoke with Andrew Anderson, Global Head Strategic Account Management and Mary Todas, Director Technical Development and Regulatory Affairs, both with Pfizer CentreOne, about best practices for API quality. 

Industry Perspectives on Quality–A Conversation with Pfizer CentreOne

Pharmaceutical Technology spoke with Niamh Lynch, Executive Director, Global Head of Quality, Lonza Small Molecules, Basel about best practices for API quality and the impact of the nitrosamine contamination situation.

Industry Perspective on API Quality–A Conversation with Niamh Lynch of Lonza Small Molecules

The nitrosamines contamination in “sartan” drugs emphasized the importance of risk assessment in the manufacture of active pharmaceutical ingredients.

What Goes Wrong When API Quality is Compromised?

Brian Carlin is global manager of pharmaceutical research and development at FMC-Biopolymer (Princeton, NJ).

George Collins is vice president, Vanderbilt Chemicals LLC. 

R. Christian Moreton, PhD, is vice-president of pharmaceutical sciences at Finnbrit Consulting and a member of Pharmaceutical Technology’s editorial advisory board.

David Schoneker is president, Black Diamond Regulatory Consulting, LLC

Jennifer Putnam is AR&D supervisor II, Perrigo

Joseph Zeleznik is manager, technical & regulatory affairs at Meggle USA.

Katherine Ulman is a Global Regulatory Compliance Manager at Dow Corning.

Stacey Bremer is Director, Product Stewardship Medical at Celanese.

This article reviews sources of excipient variability, including raw materials and processing, both of which may vary from supplier to supplier and from plant to plant for a single manufacturer.

Quality Assurance/Quality Control