Processvalidation in manufacturing of medical device_Handout

更新时间:2023-07-13 12:39:51 阅读: 评论:0

PRODUCT SERVICE
2002Process Validation PROCESS VALIDATION IN
思想政治教育考研
MANUFACTURING OF MEDICAL DEVICES
loadout
Norbert Janzen
TÜV Product Service
PRODUCT SERVICE 2002Process Validationsara lee corporation>运动的英文
PRODUCT SERVICE 2002Process Validationgreatness
dbPRODUCT SERVICE 2002Process Validation Definitions:
Installation qualification (IQ):
•Establishing by objective evidence that all key aspects of the process equipment and ancillary system installation adhere to the
manufacturer’s approved specification and that the recommendations of the supplier of the equipment are suitably considered.
Operational qualification (OQ):
•Establishing by objective evidence process control limits and action levels which result in product that meets all predetermined
自由协会
requirements.
Performance qualification (PQ):
个人陈述 英文•Establishing by objective evidence that the process, under anticipated conditions, consistently produces a product which meets all
oyamapredetermined requirements.
PRODUCT SERVICE
2002Process Validation
facebook chatDefinitions:Process validation:
•Establishing by objective evidence that a process consistently produces a result or product meeting its predetermined requirements.

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