DQ - Design Qualification

DQ - Design Qualification
  1. аттестация

3.10 аттестация (qualificfcion, validation): Подтверждение соответствия заданным требованиям.

Примечания

1. На различных этапах проектирования, монтажа и ввода в эксплуатацию объектов проводятся:

- аттестация проекта (DQ - Design Qualification);

- аттестация в построенном состоянии (IQ - installation Qualification);

- аттестация в оснащенном состоянии (OQ - Operation Qualification);

- аттестация в эксплуатируемом состоянии (PQ - Performance Qualification).

2. Для проведения аттестации требуются программа аттестации (validation master plan) и методики аттестации.

«Валидационный мастер план» - нерекомендуемый термин.

Источник: ГОСТ Р 52537-2006: Производство лекарственных средств. Система обеспечения качества. Общие требования оригинал документа


Англо-русский словарь нормативно-технической терминологии. . 2015.

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