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GMP Training – Quality Assurance and Quality Control by www.gmpsop.com
Monitoring
ICH Q10 Quality
PQS
Monitoring
CAPAs
Change
PQS KEY ELEMENTS
(a) Senior management has the ultimate
responsibility to ensure an effective pharmaceutical
quality system is in place to achieve the quality
2.1 MANAGEMENT objectives, end that role, responsibilities, and
COMMITMENT authorities are defined. Communicated and
implemented throughout the company.
(b)(5) (Management should conduct) management
reviews of process performance and product quality
and of the pharmaceutical quality system ...
3.2.1 PROCESS Pharmaceutical companies should plan and execute
PERFORMANCE AND a system for the monitoring of process performance
PRODUCT QUALITY and product quality to ensure a state or control is
MONITORING maintained.
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