Quality Assurance/Quality Control

Sep 04, 2018
By Pharmaceutical Technology Editors
As it investigates the root cause of an impurity discovered in valsartan, FDA extends its studies to APIs with similar synthesis processes.
Sep 02, 2018
Pharmaceutical Technology
Detailed process descriptions and robust documentation aid in compliance as well as training, says Siegfried Schmitt, principal consultant at PAREXEL.
Sep 02, 2018
Pharmaceutical Technology
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.
Sep 01, 2018
Pharmaceutical Technology
Sample preparation—specifically, API extraction and dilution—can introduce errors. Use of best practices and automation can reduce variability.
Sep 01, 2018
Pharmaceutical Technology
Increasingly stringent audit requirements will make third-party accredited GMP audits critical for pharmaceutical excipients and raw materials.
Sep 01, 2018
Pharmaceutical Technology
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.
Aug 29, 2018
Pharmaceutical Technology's In the Lab eNewsletter
By Pharmaceutical Technology Editors
PDA Technical Report 80 (TR 80): Data Integrity in Laboratory Systems is the first in a series of three technical reports PDA will publish on data integrity.
Aug 28, 2018
By Pharmaceutical Technology Editors
Pfizer Consumer Healthcare is recalling one lot of Children’s Advil Suspension Bubble Gum Flavored 4 FL OZ Bottle because of improperly marked dosage cups.
Aug 28, 2018
By Pharmaceutical Technology Editors
The company is voluntarily recalling one lot of Hydrochlorothiazide Tablets USP 12.5 Mg because of a labeling mix-up.
Aug 28, 2018
A wave of potentially impure drugs and APIs from China, India, and other foreign firms has prompted recalls and FDA warning letters.
native1_300x100
lorem ipsum