Topic

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

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

Videos

In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discuss how to address an FDA warning letter citation for a failure to establish a quality control unit.

Ask the Expert: Quality Control Units

Articles

Poor API quality may often lead to delays in production and a shortage of supply.

Poor API Quality Threatens a Healthy Supply

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

Calquence (acalabrutinib) plus bendamustine and rituximab reduced risk for disease progression or death by 27% compared with the current standard of care, according to a phase III trial.

EU Approves AstraZeneca Mantle Cell Lymphoma Treatment

FDA chooses Dr. Vinay Prasad, MD, MPH, a hematologist-oncologist, to lead the Center for Biologics Evaluation and Research at FDA.

New CBER Director Appointed

, is senior manager, Manufacturing Science and Technology (MSAT), at AGC Biologics.

This article explores the impact of test volume, microbial distribution, and dilution errors on bioburden testing variability. It presents statistical approaches to estimate percentage error and discusses strategies to optimize microbial enumeration techniques in biopharmaceutical quality control.

Understanding the Variability in Bioburden Test Results in Biomanufacturing

Amit Chivate, senior market manager, Greater Asia and China, Roquette, provides his perspective on FDA’s recommendations regarding nitrosamines. 

Strategies for Mitigating Nitrosamine Risk

The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.

Trump Directs FDA, EPA to Reduce Regulatory Barriers to Domestic Pharma Manufacturing

The company said the expansion is in response to globally rising demand for inhaled biologics, which offer distinct advantages in route of administration, but can be challenging products for developers.

Intertek to Expand UK GMP Facility with 6000 Square Feet of Lab and Office Space

While global harmonization exists, there are still differences between the US and European GMP requirements that manufacturers should know, says Siegfried Schmitt, PhD, vice president, Technical at Parexel.

Complying with European versus US GMPs 

Aviva Capital Partners and developer Socius are investing £1 billion to develop a cancer research and treatment center in Sutton, London.

Quality Systems