Page 22 - QA and QC

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

Monitoring the supply chain

Change management

Changes to products and processes are some of the hardest areas to manage in
a pharmaceutical company. Often, changes have to be approved by government

agencies before the changes can take place. The QA Department oversees the
change programs.

CHANGE MANAGEMENT SYSTEM

Phase 1
Staffing the process requires a change request to be
raised. It is required for the correction of a problem
CHANGE and/or an improvement opportunity. Sources of a
REQUEST change request could be from anyone in manufacturing

or QC or even from regulatory agencies. Change requests
are formalized and given unique change tracking
numbers.

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