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With stability testing, pharmaceutical industry inspects the quality of drug substances and drug products as per the guidelines outlined by US Food and Drug Administration and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use to make sure that they retained the quality over the period of time.
There are many industries where moisture control is critical. Moisture sensitive foods and pharmaceuticals are put in packaging with controlled MVTR to achieve the required quality, safety, and shelf life. In clothing, MVTR as a measure of breathability has contributed to greater comfort for wearers of clothing for outdoor activity.
When the two tendencies are in balance— and the air and food are stable—the air's relative humidity (expressed as a fraction instead of as a percentage) is taken to be the water activity, a w. Thus, water activity is the thermodynamic activity of water as solvent and the relative humidity of the surrounding air at equilibrium.
It also reauthorizes the Prescription Drug User Fee Act. The PFUDA was first enacted in 1992 to allow the FDA to collect application fees from pharmaceutical companies when applying for approval for a drug. Since then, it has been reauthorized three times; first in 1997, then 2002, and most recently with the passage of the FDAAA in 2007.
The Comprehensive Drug Abuse Prevention and Control Act of 1970, Pub. L. 91–513, 84 Stat. 1236, enacted October 27, 1970, is a United States federal law that, with subsequent modifications, requires the pharmaceutical industry to maintain physical security and strict record keeping for certain types of drugs. [1]
Title II, the Drug Supply Chain Security Act (DSCSA), established requirements to facilitate the tracing of prescription drug products through the pharmaceutical supply distribution chain. These requirements included a ten-year timeline culminating in the building of "an electronic, interoperable system to identify and trace certain ...
Therefore, an in-room dehumidifier will always warm the room and reduce the relative humidity indirectly, as well as reducing the humidity more directly, by condensing and removing water. Diagram showing airflow through a heat-recovering dehumidifier. Warm, moist air is drawn into the unit at A in the diagram above.
Hatch-Waxman amended the Federal Food, Drug, and Cosmetic Act. Section 505(j) of the Act, codified as 21 U.S.C. § 355(j), outlines the process for pharmaceutical manufacturers to file an Abbreviated New Drug Application (ANDA) for approval of a generic drug by the Food and Drug Administration (FDA). [4]