《McCullough_PDA MetroChapDay》.pdfVIP

Identification and Control of Critical Process Points Using Complementary Risk Assessments (corrected) Karen McCullough MMI Associates (908) 534-6463 PDA Metro Chapter Day June 2, 2009 RISK is a four letter word  Over-encouraged  Over-exposed  Misunderstood  Misapplied  The process is subject to unfounded assumptions and opinion to influence the result Pre-emptive Risk  When is the best time to assess risk?  Before a failure occurs!  Objective  Unemotional  When is the worst time to assess risk?  Before a bad decision is made  After a bad decision is made  Pressure to come to a certain conclusion GMP and Standards References  Guidance for Industry: Q9 Quality Risk Management /cder/guidance/7153fnl.htm  Pharmaceutical cGMPs for the 21st Century: A Risk Based Approach  ISO 14971:2007, “Medical devices - application of risk management to medical devices” Getting Started  Identify and assemble a cross functional team  Describe/understand the product, its formulation and its distribution  Identify and understand the intended use and quality attributes of the product  Develop a flow diagram that describes the process  Understand processing methods Risk Assessment 1: HACCP  Hazard Analysis and Critical Control Point  Pillsbury created HACCP in the 1960s as a process control mechanism for food for NASA  FDA adopted HACCP as a requirement for process control in the food industry  Hazard Analysis and Critical Control Point Principles and Application Guidelines, August 1997, /~comm/nacmcfp.html  HACCP identified as a risk assessment t