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《Implementation_of_QRM_at_Roche_PDA_Dinner_Sept_29-2016 Ram》.pdf
Quality Risk Management Implementation at Roche
PDA West Coast Chapter 2011 Professional Dinner Meeting Series
Sept 29, 2011
Emma Ramnarine
Head, Global QRM, Genentech
1 of 25
Current Status of QRM in the Industry
Integrating QRM in the Product Lifecycle
Critical success factors
2
Current Status of QRM in the Industry
• QRM is legally enforceable (i.e. EU GMPs)
• ICH Q8, Q9 and Q10 expect:
– QRM application throughout the product and
process lifecycle
– Integration of QRM into the Pharmaceutical
Quality System (PQS)
• Regulatory agencies focus on use of risk
assessments has increased significantly
– Increased use of risk assessments to address
inspection observations
– Inspection observations due to inadequate
risk management
– Regulators are seeking formal training on
QRM
– Increase in risk based regulatory filings (e.g.
comparability protocols)
3
QRM Implementation
Tools
Typically starts with reactive risk assessments
Level of detail and complexity can vary by
company size, but some basic program )
d
o
should be in place o
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