RT Journal Article
SR Electronic
T1 The Changing Role of Quality Assurance in the Pharmaceutical Industry
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 313
OP 319
DO 10.5731/pdajpst.2014.00987
VO 68
IS 4
A1 Kieffer, Robert G.
YR 2014
UL http://journal.pda.org/content/68/4/313.abstract
AB ICH Q10. Pharmaceutical Quality System emphasizes that senior management is responsible for the quality system. Thus, it is not the quality assurance organization that has the primary responsibility for the quality system. With this shift of responsibilities, what can quality assurance do to help senior management fulfill their responsibility? How can quality assurance be more proactive, add more value? What new skills does quality assurance need to have in order to perform its new role? This article attempts to answer these questions.