Manufacturing

Articles

The company issues a voluntary nationwide recall due to the presence of particulate matter in a single vial.

Hospira Recalls One Lot of Hydrochloride for Injection, USP

The company was cited by FDA for violations of sterile processing GMPs.

Wockhardt Limited Receives FDA Warning Letter

Partner at Jacobs Wyper Architects, 1232 Chancellor St., Philadelphia, PA, 19107, tel: 215.985.0400, www.jacobswyper.com.

Airlocks, gowning rooms, and transition spaces have different uses and should be considered separately in cGMP pharmaceutical facility design.

Airlocks for cGMP Facilities

Wockhardt Limited received a warning letter from FDA for CGMP violations.

FDA Cites Facility for Aseptic Processing Violations

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

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.

Aseptic/Sterile Processing