1 Essential aspects in the ACE and ANDA IR QbD case studies June 6, 2012 Michal Arnon, Formulation R&D Manager, Perrigo Pharmaceuticals Israel Agenda • QbD Definition • QbD Example for NDA “ACE Tablets” Case study • Specific emphasis for Generic Products (GPhA/FDA CMC Workshop – May 2012) • QbD Example for ANDA – IR Tablets • Summary
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1
Essential aspects in the ACE and
ANDA IR QbD case studies
June 6, 2012
Michal Arnon, Formulation R&D Manager,
Perrigo Pharmaceuticals Israel
Agenda
• QbD Definition
• QbD Example for NDA “ACE Tablets” Case study
• Specific emphasis for Generic Products
(GPhA/FDA CMC Workshop – May 2012)
• QbD Example for ANDA – IR Tablets
• Summary
2
QbD - Definition
• Systemic Approach
• Predefined Objectives
• Product and Process Understanding
• Control
• Based on Quality Risk Management
Six Steps to QbD1. Define QTPP
2. Define CQA
3. Risk Assessment
4. Lab work, DOE to
identify Critical
Parameters
5. Determine Control
Strategy
6. Update Risk
Assessment
Define Your Quality Target
Product Profile
Critical Quality Attributes
3
Pharmaceutical Development
Case Study:
“ACE Tablets”
Prepared by CMC-IM Working Group
March 13, 2008
CriticalityTargetQuality Attribute
Not ApplicableTablet, Maximum weight 200mgDosage form
CriticalTablet confirm with the description of
shape and sizeAppearance
Critical95-105%Assay
CriticalACE 12345 NMT 0.5%
Other imp. NMT 0.2%
Total NMT 1%
Impurities
Not critical – API not
sensitive to hydrolysisNMT 1%Water content
CriticalMeets USPContent Uniformity
Not critical since related to
dissolution5-12 kPHardness
Not CriticalNMT 1%Friability
CriticalConsistent with immediate releaseDissolution
Not critical, a precursor to
dissolutionNMT 15 min.Disintegration
Critical only if drug product
support microbial growthMeets USP criteriaMicrobiology