Page 9 - Introduction QC
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GMP Training – Introduction to Quality Control (QC) by www.gmpsop.com
Self-inspections or internal audits, are requirements
under GMP. The purpose of a self-inspection is to
independent check that the rules and documents
AUDIT
established by QA management are being followed.
Self-inspections also provide opportunities to
improve procedures and practices in the factory.
Corrective action is required when an internal audit
reveals a problem that might affect the quality of a
product.
CORRECTIVE
ACTION 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.
Contents of a laboratory quality manual
The quality manual should specifically describe or refer to:
the Laboratory Quality Policy, commitment and objectives
the standard of service and governing standards (e.g. ISO 17025, GMP)
laboratory SOPs and technical methods
how independence of judgment is demonstrated
the responsibilities and authority for key personnel
qualifications and job descriptions (organizational structure)
the management elements of ISO 17025
deployment of the procedures and standards and training for personnel
QA program (audit, review & improvement)
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