Acceptable Daily Exposure to The Pharmaceutic...

Acceptable Daily Exposure to The Pharmaceutical Industry

Author Name : Autade K. A*, Albhar S. N, Sumbe R B, Misar P.L, Raut K.G

ABSTRACT

Biotechnology firms must set safe or acceptable limits for pharmaceutical and chemical plant production based on a portion of the therapeutic dose for humans or of the lethal dose in experimental animals. The International Society for Pharmaceutical Engineering (ISPE) recently released Baseline Guide® Risk-Based Manufacture of Pharmaceutical Products, which offers more medically sound risk assessment methods (Risk-MaPP) The ADE serves as a reliable starting point for further cleaning validation calculations because it is based on all available safety data, not only the lowest dose. When reviewing cleaning residue data, the adoption of the ADE will also give a scientific foundation for the "Margin of Safety," and from an operational aspect, this will provide considerably more flexibility than with the dose-based criterion. When reviewing cleaning residue data, the adoption of the ADE will also give a scientific foundation for the "Margin of Safety," and from an operational aspect, this will provide considerably more flexibility than with the dose-based criterion.As previously mentioned, the ADE is a very conservative value, and applying it in cleaning validation will produce very conservative "safe" levels.) The technique for determining an Acceptable Daily Exposure (ADE) and the level of scientific rigor required to determine ADE values are described in the following study (1).

Keywords: ADE, NOAEL, cleaning validation, safety factor, anduncertainty factor.