Page 12 - QA and QC
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GMP Training – Quality Assurance and Quality Control by www.gmpsop.com
It is a GMP requirement that documentation must
be followed exactly. Following documentation also
helps minimize mistakes.
Training
Training is an essential requirement under GMP:
personnel must be trained before they are
approved to perform a job. Untrained personnel
will eventually make errors and mistakes that can
cost lives.
It is a GMP rule that staffs are trained to the
approved documents applicable to their work
areas, and they must sign to the effect that they
understand the requirements.
Self-inspection (internal audit)
Self-inspections, or internal audits, are
requirements under GMP. The purpose of a self-
inspection is to independently check that the rules
and documents established by QA management
are being followed. Self-inspections also provide
opportunities to improve procedures and practices
in the factory.
Corrective Actions
Corrective action is required when an internal
audit reveals o problem that might affect the
quality of a product. Corrective action may also be
required when a problem occurs in production.
Corrective actions must be documented, and
incorrect procedures updated, in order to improve
the company's quality plan.
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