In the external use drug manufacturing, it was found that the active ingredient content tend to
be less than the specification. The objective of this research was to improve the manufacturing process
in order to control the content of active ingredient to meet the specification. According to root causes
that affected the reduction of content were (1) the sequence of fill materials in the chemical solution
was not suitable as a result of chemical reaction, (2) tool and method for spinning the solution in 3,000
liter tank was inappropriate, the solution and its active ingredient was not homogeneous. Therefore, the
countermeasures were (1) sequencing of fill materials in the chemical solution based on pH,
(2) installation of a pump to stir the chemical solution homogeneous. The result revealed that the
active ingredient content could meet the specification.
Keywords
External Use Drug, Active Ingredient Content, Ingredient Content Control