Question: Select ALL true statements regarding quality systems. Question 1 Select one or more: a . If an analytical test exists for each attribute of the
Select ALL true statements regarding quality systems.
Question Select one or more:
a
If an analytical test exists for each attribute of the final drug product, QC testing alone can be used to ensure quality product.
b
Management responsibilities within the Quality System are listed in a company's "Management Manual".
c
Standard Operating Procedures are part of the Quality System.
d
The Management System is the heart of the Quality System.
e
ICH Q includes guidance on quality for drug development.
f
When the FDA writes a Warning Letter and lists GMP infractions at a manufacturing facility, it addresses the letter to the company president.
g
The FDA's Center for Drug Evaluation and Research coined the term "Quality System".
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