Page 19 - QA and QC

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

Government regulators will visit the factory at least every
2 years on overage to conduct on independent inspection
of the facility and manufacturing practices. The outcome
of the inspection may determine the issue or retention of
a GMP manufacturers license, so these audits are very
important.

Sometimes problems arise in the factory that may raise
safety or quality concerns with a product or production
line. When this happens, senior management may
initiate an investigation or audit of the area concerned to
see if the real cause of the problem can be identified and
fixed.

GMP rules require that products be annually analyzed
for trends. The purpose of this is to look for changes in
product quality that may be occurring over time. These
trend reports must be retained and provided to

government auditors if requested.

GOOD TO KNOW – EXTERNAL AUDITS

External audits are generally conducted by purchasers, contractors, and
accrediting bodies.

Generally, an external audit will include at least the following areas:

the quality management system

written procedures

validation of processes

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