PRODUCT SERVICE
2002Process Validation PROCESS VALIDATION IN
MANUFACTURING OF MEDICAL DEVICES
Norbert Janzen
TÜV Product Service
validation verification
PRODUCT SERVICE 2002Process Validation
PRODUCT SERVICE 2002Process Validation
PRODUCT 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
requirements.
Performance qualification (PQ):
•Establishing by objective evidence that the process, under anticipated conditions, consistently produces a product which meets all
predetermined requirements.
PRODUCT SERVICE
2002Process Validation
Definitions:Process validation:
•Establishing by objective evidence that a process consistently produces a result or product meeting its predetermined requirements.

版权声明：本站内容均来自互联网，仅供演示用，请勿用于商业和其他非法用途。如果侵犯了您的权益请与我们联系QQ:729038198，我们将在24小时内删除。