RT Journal Article
SR Electronic
T1 PDA Survey of Quality Risk Management Practices in the Pharmaceutical, Devices, & Biotechnology Industries
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 1
OP 21
VO 62
IS 1
A1 Ahmed, Ruhi
A1 Baseman, Harold
A1 Ferreira, Jorge
A1 Genova, Thomas
A1 Harclerode, William
A1 Hartman, Jeffery
A1 Kim, Samuel
A1 Londeree, Nanette
A1 Long, Michael
A1 Miele, William
A1 Ramjit, Timothy
A1 Raschiatore, Marlene
A1 Tomonto, Charles
YR 2008
UL http://journal.pda.org/content/62/1/1.abstract
AB In July 2006 the Parenteral Drug Association's Risk Management Task Force for Aseptic Processes, conducted an electronic survey of PDA members to determine current industry practices regarding implementation of Quality Risk Management in their organizations. This electronic survey was open and publicly available via the PDA website and targeted professionals in our industry who are involved in initiating, implementing, or reviewing risk management programs or decisions in their organizations. One hundred twenty-nine members participated and their demographics are presented in the sidebar “Correspondents Profile”. Among the major findings are The “Aseptic Processing/Filling” operation is the functional area identified as having the greatest need for risk assessment and quality risk management.The most widely used methodology in industry to identify risk is Failure Mode and Effects Analysis (FMEA). This tool was most widely applied in assessing change control and for adverse event, complaint, or failure investigations.Despite the fact that personnel training was identified as the strategy most used for controlling/minimizing risk, the largest contributors to sterility failure in operations are still “Personnel”.Most companies still rely on “Manufacturing Controls” to mitigate risk and deemed the utilization of Process Analytical Technology (PAT) least important in this aspect.A majority of correspondents verified that they did not periodically assess their risk management programs.A majority of the correspondents desired to see case studies or examples of risk analysis implementation (as applicable to aseptic processing) in future PDA technical reports on risk management.