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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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
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 everythingThe Changing Environment
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