ABSTRACT

High-quality water and air are essential for the manufacture of pharmaceuticals. Water is the most commonly used raw material in pharmaceutical manufacturing; it is indirectly used in the manufacture of all dosage forms for cleaning manufacturing equipment, and is also used as a major component which constitutes injectable products. It is the one raw material that is usually processed by the pharmaceutical manufacturer prior to use because it cannot be used as supplied by the vendor. Water should be regarded as one of major raw materials for the manufacture of pharmaceuticals whether or not it remains as a component of the finished dosage form or is eliminated during the manufacturing process. Water is thus an important raw material in GMP and in validating the manufacturing process.