Quality Systems

David G. Dolan is senior manager, Occupational, Environmental, and Quality Toxicology at Amgen Inc.

Markus Schwind, PhD, is HSE manager at Sanofi-Aventis Deutschland GmbH, HSE Germany, Industriepark Hoechst, Bldg. H831, Room A.04.72.2, D-65926 Frankfurt am Main, Markus.Schwind@sanofi.com. 

Camille (Bossard) Jandard, Pharm.D, MSc, is toxicology project leader and occupational toxicologist at Biologie Servier, 905 route de Saran, 45520 GIDY, France, camille.jandard@servier.com. 

Gregor Tuschl, PhD is principal scientist, Early Non-Clinical Safety, Merck KgaA, Frankfurter Str. 250, U009/101, 64293 Darmstadt, Germany, gregor.tuschl@merckgroup.com. 

Claudia Sehner, PhD, is principal scientist, Nonclinical Drug Safety, Boehringer Ingelheim Pharma GmbH & Co. KG, claudia.sehner@boehringer-ingelheim.com. 

Articles

In this study, the authors investigated the relationship between the 0.001 MinDD and the PDE values for 140 drug substances as an attempt to identify high-risk groups of products for patient safety. This comparison can serve as a method for prioritization of APIs for development of PDEs.


Comparison of Permitted Daily Exposure with 0.001 Minimal Daily Dose for Cleaning Validation

Truxton, Inc. is voluntarily recalling one lot of Phenobarbital Tablets, USP, 15 mg because of a labeling error on declared strength.

Phenobarbital Recalled Due to Labeling Error

The complex nature of biologics adds additional CQAs that must be determined to ensure the safe development of biologics

Critical Quality Attributes Challenge Biologics Development

Susan Haigney is lead editor of Pharmaceutical Technology and Pharmaceutical Technology Europe.

Pharmaceutical Technology asked Siegfried Schmitt, principal consultant at PAREXEL, about the importance of quality agreements in the sponsor/contractor relationship.

The Importance of Quality Agreements

Mike Jovanis is the vice president of product management at Sparta Systems

More life-sciences companies are starting to manage global suppliers holistically.

Getting, and Staying, Ahead of Global Quality Demands

Philip Lienbacher is head manager of raw material policy ownership at Shire, Vienna.

Manfred Karner is head of material lifecycle management at Shire, Vienna.

By working together and taking a QA-based approach, manufacturers and suppliers can reduce raw material testing requirements.

Collaborating for Efficiency and Safety in Raw Material Inspection

Agnes Shanley is senior editor of Pharmaceutical Technology.

As pharmaceutical quality metrics evolve, they will need to incorporate more of the principles of operational excellence, says consultant Prabir Basu.

Defining Quality: Joining the Quality Lab and the Plant Floor

Could greater market transparency improve pharmaceutical quality and regulatory compliance?

Could Greater Transparency Improve Pharmaceutical Quality and Compliance?

The new facility will focus on formulation development, drug product analytical development, and quality control.

Lonza Holds Grand Opening of New Drug Product Services Labs

Outcry against high pharmaceutical pricing brings questions of high R&D costs and restrictive payers, but also drug development and manufacturing efficiency.

Quality Assurance/Quality Control