Building Automation for Pharmaceutical Manufacturing
- FDA Inspections and Warning Letters Continue to Decline. Greb, Erik // Pharmaceutical Technology;May2007, Vol. 31 Issue 5, p22
The article reports on the decline of the number of U.S. Food and Drug Administration (FDA) inspections of biologic and drug-manufacturing facilities in fiscal 2006, according to a report by the Office of Regulatory Affairs. According to the report, the Center for Drug Evaluation and Research...
- Evaluating Design Margin, Edge of Failure, and Process Capability. Little, Thomas A. // BioPharm International;Sep2014, Vol. 27 Issue 9, p46
The article discusses the design space generation in new product development. Topics discussed include definition of design space in International Conference on Harmonization (ICH)'s glossary, increase in product, process knowledge and reduction in risk with the ICH standards and adds that...
- Optimising Quality by Design in Bulk Powders and Solid Dosage. Winters, Conrad; Neves, Filipe // Pharmaceutical Technology Europe;Sep2013, Vol. 25 Issue 9, p72
The article discusses the ways to optimization of the U.S. Food and Drug Administration's quality by design (QbD) initiative to increase manufacturing process understanding of the drugs. It mentions the steps of the QbD process which include Critical quality attributes (CQAs), risk assessment,...
- FDA Seeks Streamlined, More Effective GMP Inspections. Wechsler, Jill // Pharmaceutical Technology;May2007, Vol. 31 Issue 5, p30
The article reports on the plan of the U.S.. Food and Drug Administration (FDA) to shut down its regional offices and some additional field facilities. FDA aims to make more efficient use of its limited resources by establishing risk-based approaches for selecting those drug-manufacturing sites...
- A big pill to swallow. Policastro, Ellen Fussell // InTech;Apr2007, Vol. 54 Issue 4, p16
The article discusses how good automated manufacturing practices (GAMP) and process analytical technologies (PAT) help manufacturers gain an edge in U.S. Food and Drug Administration audits in the wake of several incidences of contaminated foods. According to Dennis Brandl, president of BR&L...
- Regulation and Compliance Q&A. // Pharmaceutical Technology;Jul2012, Vol. 36 Issue 7, p20
The article provides an answer to a question on how pharmaceutical plants could prepare for the U.S. Food and Drug Administration (FDA) inspections.
- New FDA Office Monitors Drug Quality. // Chain Drug Review;3/17/2014, Vol. 36 Issue 5, p94
The article offers information on the necessity of creation of a quality testing unit to check drug quality after U.S. Food & Drug Administration (FDA) banned sales of generic medicines in the U.S. manufactured from several Indian manufacturing plants.
- FDA Takes Two Important Actions on Drug Shortages. // Chicago Citizen - Chicago Weekend Edition;11/ 6/2013, Vol. 43 Issue 44, p3
The article informs that the U.S. Food and Drug Administration (FDA) has taken two steps to prevent drug scarcity including implementation of the Food and Drug Administration Safety and Innovation Act, and issuance of a rule for drug manufacturers to notify about interruption in drug manufacturing.
- WEEK IN WASHINGTON. // BioWorld Insight;3/ 4/2013, Vol. 21 Issue 10, p6
The article announces that the U.S. Food and Drug Administration (FDA) is on track to start its biennial inspections of all domestic and foreign drug facilities in five years, provided that budget constraints will not derail the plan.