(FDANews: Falls Church, Virginia) --The Food and Drug Administration recently issued proposed changes to the drug-manufacturers’ clinical good manufacturing practices (CGMPs) (21 CFR 210/211). The revised standards would affect three major areas: water quality, verification by a second individual, and aseptic processing.

Water quality—The rules remove the defined EPA water standard and replace it with “water fit for human consumption.” But the standard of what is considered fit for human consumption can vary from one country to another. Do you know what it is for your outsourced suppliers? Could your product be tainted, yet CGMP-compliant?

Verification—The changes state that when operations are performed by automated equipment, only one person is needed to verify that the automated equipment is functioning accurately.

Aseptic processing—The new rule makes numerous updates to equipment cleaning and maintenance, testing and approval or rejection of components, drug product containers and closures, sampling and testing of in-process materials, and control of contamination.

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