The control of water quality is paramount for three core reasons:

• Patient Safety: Contaminated water can introduce harmful microbes or endotoxins directly into a patient, especially with injectable drugs, leading to severe infections, septic shock, or other adverse reactions.

• Product Efficacy and Stability: Water is a major component in many formulations. Impurities can react with the Active Pharmaceutical Ingredient (API), causing degradation, reducing potency, or forming harmful precipitates over the product's shelf life.

• Regulatory Compliance: Agencies like the FDA and EMA mandate strict adherence to Good Manufacturing Practices (GMP). A robust and validated water system that consistently produces water meeting pharmacopoeial standards is not optional; it is a legal requirement for market approval.

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