Quality Systems

Articles

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.

Mitigating the Risk from Excipient Variability

Andrew James is marketing director, Ellutia Limited.

Screening for apparent total nitrosamine content with a thermal energy analyzer offers a rapid way of identifying contaminated drug products.

Detecting Apparent Total Nitrosamine Content in Pharmaceutical Drugs

Pharmaceutical Technology Europe spoke with representatives from the European Directorate for the Quality of Medicines & Healthcare (EDQM) about API quality from their perspective.

Ensuring API Quality—The EDQM Perspective

Pharmaceutical Technology spoke with Ed Gump, VP Small Molecules at the US Pharmacopeia (USP) about API quality from the standards perspective. 

Ensuring API Quality—A Pharmacopeia Perspective

Hospira has issued a voluntary nationwide recall for one lot of Propofol Injectable Emulsion, USP (containing benzyl alcohol), due to the potential presence of visible particulate. 

Hospira Issues Voluntary Recall for One Lot of Propofol Injectable Emulsion, USP

Hallie Forcinio is packing editor for Pharmaceutical Technology and Pharmaceutical Technology Europe, editorhal@sbcglobal.net.

Exhibitors display innovations for parenteral and solid dose products. 

INTERPHEX 2022 Highlights Packaging and QC 

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

Agency leaders are moving to develop a rating system to identify those drug manufacturers with more dependable production operations.

FDA Advances Quality Initiatives to Combat Drug Shortages

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

An SOP for electronic-records archiving is a regulatory requirement and good for business, says Siegfried Schmitt, vice president, Technical at Parexel. 

The Difference between Electronic Records Retention and Archiving

Lei Lei is senior R&D director of Cutia Therapeutics, Shanghai, China, and he was principal scientist of Shanghai Johnson & Johnson Pharmaceutical Company

Ashvin Patel, PhD, is the director of Analytical Research & Business Development, Teledyne Hanson Research, New York, USA.

This article describes the in-vitro permeation test study data processing procedures and FDA statistical mathematics of evaluating a generic topical drug product, acyclovir cream, against its reference product.

Quality Assurance/Quality Control