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 1Select 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 Q10 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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