Quality By Design - A Generic Industry Perspective Edmund M. Fry Vice President of Compliance IVAX Corp. Generic Pharmaceutical Association A shared vision of quality GPhA supports the FDA CGMP initiative Generic drug manufacturing companies:
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Quality By Design - A Generic Industry Perspective
Edmund M. Fry
Vice President of Compliance
Generic Pharmaceutical Association
GPhA supports the FDA CGMP initiative
“You can’t test quality into drug products” has been heard for decades – so what’s new?
In generic pharmaceutical manufacturing, there are additional constraints
Quality by Design
Adequate resources for quality: number, qualifications, etc.
Self-assessments play key role
Continuous analysis & improvement
Change management based on good science
Focus on what’s important (risk management)
Current Regulatory Situation
Little guidance on adequate resources or qualifications
Self-assessments not trusted
Annual product reviews instead of continuous analysis
Formidable barriers to change, including intimidating enforcement emphasis
Seldom admit that anything is not important; test everything
Proven ability to operate in compliance should result in reduced regulatory burden, e.g. inspections and pre-approval review requirements
FDA is doing a good job of raising technical competence of Investigators
Continue to include all affected parties in policy-making initiatives