RT Journal Article SR Electronic T1 Quality Culture Survey Report JF PDA Journal of Pharmaceutical Science and Technology JO PDA J Pharm Sci Technol FD Parenteral Drug Association (PDA) SP 631 OP 642 DO 10.5731/pdajpst.2015.01078 VO 69 IS 5 A1 Pritesh Patel A1 Denyse Baker A1 Rick Burdick A1 Cylia Chen A1 Jonathon Hill A1 Morgan Holland A1 Anil Sawant YR 2015 UL http://journal.pda.org/content/69/5/631.abstract AB The Parenteral Drug Association conducted an anonymous global survey of quality culture in the pharmaceutical industry to determine whether there is a relationship between certain quality behaviors and certain quality attributes, and whether these quality attributes could be used as surrogates (or proxy variables) to assess quality culture. Other studies have shown that an unhealthy quality culture is a root cause of many quality or compliance issues seen by sites and organizations. Statistical analysis of survey data suggests that certain attributes are driving good behaviors, and the demographic data suggests that this relationship holds irrespective of the geographic location of the site. Executive survey respondents had a more optimistic view of the current state of quality culture than survey respondents at large, with cross-functional vision showing the biggest gap (P-value = 0.07, F-Test). The top five quality attributes that can serve as surrogates for quality culture were (1) Management communication that quality is everyone's responsibility, (2) Site has formal quality improvement objectives and targets, (3) Clear performance criteria for feedback and coaching, (4) Quality topics included in at least half of all-hands meetings, and (5) Collecting error prevention metrics. These identified mature quality attributes are related to management responsibility, and continual improvement of the pharmaceutical quality system sections of ICH Q10, and therefore may be amenable to be incorporated in audit programs or in regulatory inspections. Additional research and discussion is required to build a coherent approach, which the pharmaceutical industry and regulators can adopt.