Question: Select ALL true statements regarding quality systems. Question 1Select one or more: a. Management responsibilities within the Quality System are listed in a company's Management
Select ALL true statements regarding quality systems. Question 1Select one or more: a. Management responsibilities within the Quality System are listed in a company's "Management Manual". b. Standard Operating Procedures are part of the Quality System. c. If an analytical test exists for each attribute of the final drug product, QC testing alone can be used to ensure quality product. d. ICH Q10 includes guidance on quality for drug development. e. The FDA's Center for Drug Evaluation and Research coined the term "Quality System". f. The Management System is the heart of the Quality System. g. When the FDA writes a Warning Letter and lists GMP infractions at a manufacturing facility, it addresses the letter to the company president
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