Gmp Requirements for Process Water in Pharmaceutical Manufacturing Enterprises

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Process water in pharmaceutical manufacturing mainly refers to the water used in bottle washing and ingredient preparation processes during formulation production, as well as in the refining and washing processes during raw material production. The name of the water should avoid being related to its manufacturing process, such as deionized water, demineralized water, or distilled water. That is, the water's manufacturing process should be decoupled from its name, and instead, water should be classified according to quality indicators from a chemical and microbiological perspective (for example, the Chinese Pharmacopoeia specifies that purified water can be obtained by three different methods, and even better methods may be developed in the future).

Water for injection is generally obtained from purified water through distillation (and also reverse osmosis and ultrafiltration), achieving a chemical purity of up to 99.999% and being pyrogen-free. Since the process of preparing pure steam is the same as that of preparing water for injection from distilled water, the same multi-effect distillation machine or a separate pure steam generator can be used; therefore, pure steam is discussed together with water for injection.

The uses of process water in pharmaceutical manufacturing are shown in the table.

Water quality categories	Purpose	Water quality requirements
drinking water	1. Water source for preparing purified water 2. Initial washing of oral dosage bottles 3. Initial cleaning of equipment and containers 4. Cleaning, soaking, and extraction of Chinese medicinal herbs and prepared slices of Chinese medicinal herbs.	It should meet the hygiene standards for drinking water (GB5749-85).
Purified water	1. Water source for preparing water for injection (pure steam) 2. Equipment that directly contacts non-sterile drugs; Final washing water for utensils and packaging materials 3. Initial washing of injection and sterile medicine bottles 4. Ingredients for non-sterile drugs 5. Refining of non-sterile pharmaceutical raw materials	It should conform to the standards of the Chinese Pharmacopoeia
Water for Injection	1. Packaging materials for sterile products that come into direct contact with pharmaceuticals Final rinse water 2. Ingredients for injections and sterile rinsing solutions 3. Refining of sterile raw materials 4. Packaging materials that come into direct contact with sterile active pharmaceutical ingredients (APIs). Final washing water	It should conform to the standards of the Chinese Pharmacopoeia
pure steam	1. Sterile pharmaceutical materials, containers, equipment, sterile gowns or other items Moist heat aseptic treatment required to enter the aseptic work area 2. Moist heat sterilization of the culture medium	Pure steam condensate should meet the standards for water for injection in the Chinese Pharmacopoeia.