Manufacturing

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

Articles

Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the assessment of risk in the processing of intravenous injectable drugs.

Defining Risk Assessment of Aseptic Processes

Eric Langer has over 25 years experience in biotechnology and life sciences strategic marketing management, market research, and publishing. He has held senior management and marketing positions at biopharmaceutical supply companies. He has published and authored many books and reports on topics in Biotechnology, Large-scale BioManufacturing, and bioscience commercialization and communication. He teaches at Johns Hopkins University marketing management, biotech marketing, services marketing, and marketing in a regulated environment. In 1989 he co-founded BioPlan Associates, Inc. to provide market analysis, and strategy to biotech and healthcare organizations.

This key bioprocessing segment is expecting continued growth

Fill/Finish Outsourcing

Wells Pharmacy Network is voluntarily recalling all of its products due to sterility concerns.

Sterility Concerns Cause Recall

FDA sent a warning letter to an Illinois compounding pharmacy for violations of the Federal Food, Drug, and Cosmetic Act.

Compounder Cited for Sterile Manufacturing Violations

A process-specific preventative maintenance program improves productivity and reliability.

Maintaining Hygienic Diaphragm Valves

Gretchen L. Shearer, PhD, is a senior research chemist at McCrone Associates and an instructor at Hooke College of Applied Sciences, Westmont, IL. gshearer@mccrone.com.

Visual inspection of parenteral vials is the first step in a root cause investigation.

Taking a Closer Look at Parenteral Contaminants

Evonik’s parenteral drug delivery and commercial drug product manufacturing in Alabama passes EU GMP inspection.

Evonik Birmingham Laboratories Receives Renewal of EU GMP Certification

Randi Hernandez was science editor at Pharmaceutical Technology from September 2014 to May 2017.

Improvements to aseptic manufacturing procedures are long overdue. But how feasible is it for manufacturers to modernize fill lines of legacy products?

Parenteral Advisory: Outmoded Fill/Finish Technology

Fresenius Kabi will add to its generic, sterile injectable manufacturing at its Melrose Park, Illinois site.

Fresenius Kabi Expands US Sterile Injectables Capacity

The design of Baxter BioPharma Solutions’ aseptic filling lines provides a case study in customizing containment systems for multi-product lines

Aseptic/Sterile Processing