Page 39 - Introduction QC
P. 39
GMP Training – Introduction to Quality Control (QC) by www.gmpsop.com
Maintaining these methods as current is one of the key success factors for any
regulated laboratory.
Test methods
Laboratory test methods have a well-defined lifecycle, from origin to publication,
through to update and retirement. GMP and QC rules determine these pathways.
1. Source 2. Method 3. Published
methods development method
5. Transfer 6. Verify
4. Validation
to QC Lab suitability
7. Use method 8. Update 9. Archieve
in testing method old version
TEST METHOD LIFE CYCLE
Test methods generally originate from one of three
SOURCE
METHODS sources. These include official pharmacopoeias, new
methods from a development laboratory, and/or adopted
from literature.
During development, methods are tested for suitability
METHOD according to the product they are being used for, and the
DEVELOPMENT
analytical validation performance parameters.
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