Quality Systems

Marwan Alsarraj is the Biopharma Segment manager at Bio-Rad.

Articles

Using more exacting analytical tools can give a clearer assessment of gene-editing outcomes.

Assessing the Success of CRISPR Gene Therapies Using ddPCR

Establishing a quality culture from the top of an organization down to each and every employee ensures a safe and effective product, and saves costs.

A Robust Quality Culture Benefits All

Renato Rjavec is director of product management at Amplexor Life Sciences.

The move toward using the Digital Application Dataset Integration (DADI) project for the initial implementation of IDMP-based regulatory data submissions offers both opportunities and challenges for pharmaceutical organizations.

What DADI Means for the Pharmaceutical Industry

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

Process validation for a drug product must be done with commercial scale batches, says Siegfried Schmitt, vice president, Technical at Parexel.


Which Batch Size for Validation and Stability Studies?

Pfizer has issued a voluntary nationwide recall of lots of Accupril due to N-nitroso-quinapril content.

Pfizer Issues Voluntary Nationwide Recall of Lots of Accupril

Mylan Pharmaceuticals is issuing a voluntary recall of one batch of insulin glargine injection due to the potential for a missing label in the batch.

Mylan Pharmaceuticals Issues Voluntary Recall of Insulin Glargine Injection

Hallie Forcinio is packing editor for Pharmaceutical Technology and Pharmaceutical Technology Europe, editorhal@sbcglobal.net.

Exhibitors display primary packaging, secondary packaging, and machine innovations at this year’s INTERPHEX. 

INTERPHEX 2022 Moves Back to Spring-time Schedule

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

FDA is reviving efforts to establish a Quality Management Maturity program.

FDA Revives Initiative to Identify and Reward Quality Drug Operations 

Pharmaceutical Technology asked Jeff Elton, PhD, CEO of ConcertAI, about the role technology plays in performing CAPAs.

The Role of Technology in CAPAs

Teva has initiated a voluntary nationwide recall of one lot of IDArubicin Hydrochloride Injection USP 5mg/5 mL due to the presence of particulate matter.

Quality Assurance/Quality Control