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Chapter 9 Self-Inspection (Maintain (strict adherence to all manufacturing…
Chapter 9 Self-Inspection
Maintain
strict adherence to all manufacturing procedures & prescribed controls
to appoint a properly qualified team
to conduct inspections of its overall production & control procedure
Written procedure
describing the functions of self-inspection programme
be available & followed
Conducted
in an independent & detailed way
by designated competent person
independent audits by external experts may also be useful
Recorded report
contain all the observation made during the inspection & where applicable
proposals for corrective measures
statements on the actions subsequently taken
Purpose
review regularly status & adequacy of manufacturer's compliance to GMP
to seek any defects in quality assurance system
to establish corrective actions