The Food and Drug Administration (www.fda.gov) has announced a new draft, Guidance for Industry: ANDAs-Impurities in Drug Substances, that provides revised recommendations on what chemistry, manufacturing and controls (CMC) information to include regarding the reporting, identification, and qualification of impurities in drug substances produce by chemical synthesis.
ROLLING MEADOWS, Ill.-Cleanroom users and administrators attending ESTECH 2005-the 51st annual meeting and exposition of the Institute of Environmental Sciences and Technology
Semi tester makes move to Class 10,000 environment
The move from Sunnyvale to San Jose has also meant a new name for InTEST's TestDesign division: InTEST Silicon Valley Corp. Corporate headquarters are in Cherry Hill, N.J.
ROCKVILLE, Md.-Lester M. Crawford, DVM, acting commissioner of the Food and Drug Administration (www.fda.gov) since March 2004, has been nominated by President Bush to serve as the agency's next commissioner.
SALEM, N.H.-Boston Analytical, Inc., an independent, cGMP-compliant, contract-testing lab in Salem, N.H. (www.bostonanalytical.com), has built a new 2,500-square-foot facility designated specifically for microbiological testing.
SAN JOSE, Calif.-A software platform for pharmaceutical manufacturers promises to support FDA 21st Century cGMPs by letting companies span one or multiple manufacturing sites, tightly integrate quality management procedures with manufacturing operations and IT, and reduce the cost of FDA compliance.
FREMONT, Calif.-Two recently introduced, hands-free process optimization tools for semiconductor fabrication measure real-time, in situ temperature in solder reflow applications.
EL CAJON, Calif.-PURE Bioscience (www.pure-bioscience.com) has begun conversion of part of its manufacturing space here to a dedicated, FDA-compliant, cGMP facility for production of pharmaceutical-grade silver dihydrogen citrate (SDC).
The Institute of Environmental Sciences and Technology (IEST) is responsible for the origination, publishing, and revision of approximately 35 Recommended Practices (RPs) in topics of interest and value to the contamination control industry.
Cleanroom technology developed for traditional applications such as aseptic filling in pharmaceutical plants is increasingly being applied to distinctly 21st Century problems.
A lot can happen in ten years. Certainly 2005 seemed a long way off when I wrote the editorial for the December 1994 special forecast issue of CleanRooms.
Pharmaceutical manufacturing environments have traditionally seen particle counting as a necessary evil to demonstrate compliance with a cleanroom standard.
During last fall’s much-publicized case of flu vaccine contamination at Chiron Corp.’s Liverpool, U.K., manufacturing facility, the Food and Drug Administration’s Center for Biologics Evaluation and Research (FDA CBER; www.fda.gov) issued a warning letter to the company that summarized numerous deviations from current good manufacturing practices (cGMP)-including several aseptic processing sterilization failures.
SCOTTSDALE, Ariz.-According to research conducted by In-Stat (www.in-stat.com), companies are increasingly developing lab-on-a-chip products despite increased competition and alternative technologies.
Whatever the level and type of contamination control required by your facility, implementing and integrating the right sensors and monitors will be crucial to ensuring that it is operating at peak efficiency and maintaining adequate cleanliness levels. Here are a few of the newest sensor and critical environment monitoring products on the market.
