Page 58 - QA and QC

GMP Training – Quality Assurance and Quality Control by www.gmpsop.com

Senior management has the ultimate responsibility
to ensure an effective PQS is in place to achieve the
MANAGEMENT quality objectives, and that roles, responsibilities,
COMMITMENT
and authorities are defined, communicated and
implemented throughout the company.

Communication processes should ensure the
INTERNAL
COMMUNICATION appropriate and timely escalation of certain product
quality and PQS issues.

MANAGEMENT OF The pharmaceutical quality system extends to the
OUTSOURCED control and review of any outsourced activities and
ACTIVITIES AND quality of purchased materials.
PURCHASED
MATERIALS

Corrective and preventive action (CAPA) systems

Neither the FDA CFR 211 regulations nor international GMP standards
specifically mandate CAPA systems as part of the quality assurance system,
however, they are implied and expected. ICH Q10 makes this requirement more
explicit. A compliant CAPA system consists of the following:

CAPA SYSTEM

While not essential, it is helpful to describe the CAPA
system as a policy, since it is such a critical quality
QUALITY system element. This ensures everyone knows actions
POLICY
to fix problems essential to compliance and

improvement.

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