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164 Membranesfor Industrial Wastewater Recovery and Re-use

0 bulk pharmaceutical compounds/active pharmaceutical intermediates
(APIs),
0 over-the-counter (OTC) products -cough medicines, paracetamol, contact
lens cleaners, etc.,
0 prescription medicines (tablets, ointments, creams, liquids),
0 “health” foods (vitamin tables, energy drinks),
0 “cosmaceuticals” (antiseptic ointments, concealers),
0 aerosols/inhalers, and
0 injectable drugs.
The importance of water and water quality was increased enormously by the
introduction of parenteral (injection and intravenous infusion) therapy. Water
may be a raw material, a process intermediate, a product ingredient, or even the
product itself. Its wide use in many areas related to the production and control of
medicines demands that manufacturers pay very close attention to process water
quality. Further, apart from “mechanical” errors such as mistakes in labelling of
products, final product recalls for problems which can be related back to the
water used in production of the drug accounts for the next largest group of
product recalls.
In planning and operating a pharmaceutical water system the following are a
few of the areas that must be considered:

0 overall requirements for water,
0 specifications and purification methods to be adopted,
0 installation and validation of water systems,
0 routine quality monitoring requirements, and
0 capital and operating costs.

3.5.2 Water quality standards
The quality of materials used in the manufacture of pharmaceutical products are
all defined in pharmacopoeias. The main pharmacopoeias referred to today
are the European Pharmacopoeia (EP), the United States Pharmacopoeia
(USP 2 5) and the Japanese Pharmacopoeia (JP). The standards defined in these
pharmacopoeias are all enforceable in law and all manufacturers of
pharmaceutical products are regularly subjected to inspection by medicines
inspectors from countries where they have a licence to sell their products. These
inspections are carried out to ensure that the manufacturers are meeting the
quality and production requirements defined in their product licences, as defined
in the pharmacopoeias and as required for compliance with current good
manufacturingpractice (cGMP). A company failing to meet these standards may be
given a warning letter from the inspection authorities and a defined length of
time to rectify the problems. If this does not take place within the stipulated time
limit the company may have their licence(s) withdrawn until such time that the
problem is resolved.