Final answer:
Representative samples of product water must be analyzed periodically by an approved laboratory according to FDA's CGMP regulations, ensuring they meet purity specifications. Standards like those from AOAC require rigorous validation of disinfectants, part of broader CGMP requirements that include regular testing and quality control measures.
Step-by-step explanation:
According to FDA's Current Good Manufacturing Practice (CGMP) regulations, representative samples of product water must be analyzed periodically by an approved laboratory. The laboratory testing ensures that the water meets the required specifications for purity. For instance, the Association of Official Agricultural Chemists International (AOAC) sets protocols stating that a minimum of 59 of 60 replicates must show no growth to pass certain tests. Manufacturers use these rigorous standards to conduct use-dilution tests demonstrating the efficacy of disinfectants as required by the Environmental Protection Agency (EPA).
Collecting a water sample for clarity check involves placing the water in a clear bottle and observing it against the light. Further, during quality control processes, a 10 mL sample of water can be assessed for properties like temperature. These protocols are part of the broader CGMP requirements which mandate regular and systematic testing, including volume accuracy checks performed by quality control chemists in pharmaceutical settings. Such checks may involve verifying the volume dispensed by machinery, as evidenced by the careful measurement of liquids like cough syrup into storage bottles.