Quality Systems

Articles

FDA testing has found an additional impurity, N-Nitrosodiethylamine, in the API valsartan.

Additional Impurity Found in Valsartan

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

FDA is revising its inspection process and seeks harmonization of standards for US and foreign regulatory oversight to ensure the safety of medicines.

FDA Clarifies Worldwide Inspection Policies

FDA, innovator companies, and biosimilar developers maneuver over exclusivity, naming, interchangeability, and more.

Biosimilars Battles Heat Up

Gore’s new flexible freeze containers are designed to protect high-value drug substances from container breakage or leakage.

Gore Launches New Flexible Freeze Containers

As it investigates the root cause of an impurity discovered in valsartan, FDA extends its studies to APIs with similar synthesis processes.

FDA Expands NDMA Investigation to All ARB Class Drugs

Amy Thanavaro is R&D scientific manager, STERIS.

Chris Edlin, PhD, is currently director of drug development and head of Pharmaceutical Sciences in Respiratory R&D for Teva Pharmaceuticals Ireland.

Dijana Hadziselimovic is a technical services laboratory specialist for the Life Sciences Division at STERIS.

Adeyinka Aina, PhD, MRSC, is an innovation fellow at the Pharmaceutical Manufacturing Technology Centre, University of Limerick.

Paul Lopolito is a technical services senior manager for the Life Sciences Division at STERIS.

This article focuses on applying new and traditional techniques to design a cleaning process, ensure the surfaces are clean, and develop rinse solution analysis to continuously monitor cleaning performance.

Rethinking Cleaning Validation for API Manufacturing

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

Detailed process descriptions and robust documentation aid in compliance as well as training, says Siegfried Schmitt, principal consultant at PAREXEL.

Checking Incoming Goods

Andrew Teasdale, PhD, is a Principle Scientist at AstraZeneca.

Nancy Lewen is research fellow, CSD Analytical chemistry, Bristol-Myers Squibb.

Elisabeth Corbett is associate director, Global Regulatory Sciences, CMC, Bristol-Myers Squibb.

Lina Wong is associate director, Global Quality Assurance, Allergan.

Shoreh Shabrang is senior consultant RA CMC, SAABAS LLC.

The authors support the retiring of Ph. Eur. and USP heavy metal assays and propose a means of updating related specifications with minimal regulatory burden.

Pharma Collaboration Proposes Retirement of Obsolete Heavy Metals Tests

Ralph D. Lindblad, ASQ CQA, is product quality manager, Catalent Pharma Solutions.

David B. Klug is vice-chair of user relations at IPEC-Americas.

Douglas G. Muse is consultant—Compendial Affairs, Eli Lilly & Co.

Phyllis Walsh is associate director of Merck and Company, Inc.

Katherine L. Ulman is president of KLU Consulting.

Priscilla Zawislak is global regulatory affairs advocacy manager, DuPont Nutrition & Biosciences

Increasingly stringent audit requirements will make third-party accredited GMP audits critical for pharmaceutical excipients and raw materials.

Third-Party Audits: Ensuring That Excipients Meet cGMP Requirements

Agnes Shanley is senior editor of Pharmaceutical Technology.

Sample preparation-specifically, API extraction and dilution-can introduce errors. Use of best practices and automation can reduce variability.

Quality Assurance/Quality Control