Pharmaceutical manufacturing process unit (PMPU)

Pharmaceutical manufacturing process unit (PMPU) means the process, as defined in this subpart, and any associated storage tanks, equipment identified in 63.1252, and components such as pumps, compressors, agitators, pressure relief devices, sampling connection systems, open-ended valves or lines, valves, connectors, and instrumentation systems that are used in the manufacturing of a pharmaceutical product.


40 CFR § 63.1251

Scoping language

Terms used in this subpart are defined in the Act, in subpart A of this part, or in this section. If the same term is defined in subpart A of this part and in this section, it shall have the meaning given in this section for the purposes of this subpart.

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