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.
Air supplied to
the pharmaceutical manufacturing area or the air in the environment of the
pharmaceutical manufacturing area always contacts with pharmaceuticals, and the
quality of air influences the quality of the pharmaceuticals manufactured,
particularly in their cleanliness, particulates, and microbial quality.
Temperature and humidity in the manufacturing environment also influence the
quality of the pharmaceuticals manufactured. The importance of air quality and
air handling system are described in CFR 211-46 as part of GMP.
The USP
identifies several grades of water that are acceptable for use in pharmaceuticals,
and also defines the quality of the environment or the quality of air for the
manufacturing of pharmaceuticals according to its criticality. Water and the
environment must be periodically monitored for these quality attributes, and in
some instances the results are not available for days after the sample is
obtained. Meanwhile, the water would have been used to manufacture a great
number of pharmaceutical products or else the products would have already been
exposed to the environment. Water treatment and air handling systems are highly
dynamic, and careful attention has to be paid to their operation, even though
this may sometimes be somewhat unreliable. Consequently, they must be validated
and then closely monitored and controlled.
The purpose of
validation is to demonstrate the capability of the water treatment and air
handling system to continuously supply the required quantity of water and air
with the specified quality attributes. “Documented” means to provide documented
“evidence.” Validation provides the system owner with the means of assessing
when a water treatment and/or air handling system is operating outside
established control parameter limits and provides a means for bringing the
system back into a state of control. It results in written operating and maintenance
procedures for personnel to follow, which in turn helps ensure
consistent
system performance.
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