Quality assurance

Quality assurance means a system for ensuring the quality of active ingredients, PET drugs, intermediates, components that yield an active pharmaceutical ingredient, analytical supplies, and other components, including container-closure systems and in-process materials, through procedures, tests, analytical methods, and acceptance criteria.

Source

21 CFR § 212.1

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Scoping language

The following definitions apply to words and phrases as they are used in this part. Other definitions of these words may apply when they are used in other parts of this chapter.

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