Quality Systems

Articles

Cell-line quality has a significant impact on biologic drug quality; learn more about this and other upstream challenges at the new bioLIVE launching this year adjacent to CPhI Worldwide 2018.

Maintaining Cell-Line Integrity is Critical to Product Quality

FDA sent a warning letter to Lernapharm (Loris) Inc. detailing the company’s lack of procedures to prevent microbiological contamination.

Sterile Manufacturing Issues found at Canadian Manufacturer

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.

Quality Assurance/Quality Control