Page 29 - QA and QC
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GMP Training – Quality Assurance and Quality Control by www.gmpsop.com
test methods
All records have to be accurately documented as well, including:
batch records
test records
distribution records
equipment log books
training records
Essential GMP requirements
GMP compliance encompasses many activities that are documented in the GMP
regulations, codes and rules.
ESSENTIAL GMP REQUIREMENTS
Validation:
According to the international GMP definition,
validation is “the action of proving (in accordance
with GMP) that any procedure, process,
equipment, material, activity, or systematically
leads to expected results."
The FDA's definition of validation is "establishing
documented evidence which provides a high
degree of assurance that a specific process will
consistently product a product a meeting its pre-
determined specifications and quality attributes."
Process Control:
GMP regulations require that all processes
operate "in control". In practice, this means that
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