Generic Drug Manufacturing Landscape
Generic drug manufacturing is coming into its own, driving cost savings to consumers and revving economic engines around the world. With great power comes great responsibility, and leading regulators are scrutinizing generic drug-manufacturers as never before. PhM's editor-in-chief Steven Kuehn takes a close look at issues facing the industry, from the impacts and expectations of GDUFA, to coming labeling guidance and biosimilars.
Operations Executive Profile
PhM's editor goes on-on-one with an industry leader.
USP Microbial Examination Of Non-Sterile Products
Many products released to the market are not required to be sterile, including over the counter medicines, creams and supplements. The microbial quality of these products is ensured because the manufacturers are required to evaluate the microbial content of each product. To accomplish this, microbial examination of nonsterile products is performed. The test is used to determine the bioburden of the product and also if objectionable organisms are present. Authors James E.T. Gebo, Laboratory Services and Kimberly Kitch, Microtest Laboratories, Inc. provide a roadmap to the regulations of the non-Sterile Testing World for manufacturers to help understand how the recent harmonization of the USP, EP, and JP requirements affects the processing of raw materials and finished products.
Information & Data Management
SCADA System Helps Pharma Firm Comply
Engineering firm Retel Neuhausen AG and SCADA software provider InduSoft help Merck KGaA in Darmstadt, Germany, the world's oldest pharmaceutical company, meet new European and U.S. requirements.
Technology at Work
Autonomous, Flexible Environments for Pharmaceutical Facilities
G-CON Manufacturing and Rockwell Automation team up to deliver the PODs-enabled rapid construction and commissioning of flexible and scalable pharmaceutical facilities. From the discovery of a newly created drug, a drug manufacturer has a limited amount of time to reap the rewards of its invention before its patent expires and generic products enter the market; modular technology can help make the leap.
Supply Chain Excellence
Incorporating Risk-based Asset Management into your Drug Shortage Prevention Program
Risk-based asset management policies and practices for physical assets are valuable additions to operations within the pharmaceutical industry. Author David J. Mierau, Life Cycle Engineering explores how risk-based asset management practices have strong parallels to commonly used quality risk management (QRM) concepts, and have specific benefits related to preventing drug shortages.
Temperature, Pressure & Humidity
Product round-up from prominent equipment suppliers.
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