Page 14 - QA and QC
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GMP Training – Quality Assurance and Quality Control by www.gmpsop.com
Chapter 1 Quality Management
1.1. Quality Assurance is a wide-ranging concept, which covers all matters,
which individually or collectively influence the quality of a product. It is the sum
total of the organized arrangements made with the objective of ensuring that
medicinal products are of the quality required for their intended use. Quality
Assurance therefore incorporates Good Manufacturing Practice plus other
factors outside the scope of this Guide.
Overview
QA is a wide-ranging concept that covers all matters affecting product quality.
Each company may interpret its QA responsibilities slightly differently.
QA generally includes the oversight and management of:
compliance with government GMP regulations
documented procedures and GMP
control over starting materials
in-process controls and validation
QC testing of finished products
Self-inspections I internal quality audits
release for sale
product reviews and trends
storage and distribution
The need for documentation, records and traceability
GMP regulations require that all stages of manufacture are documented in order
to enable traceability. Compliant documentation allows an investigation, if
required into the manufacture of the batch. It also allows traceability to where
products were sent.
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