Introduction To QA in Pharma
Introduction To QA in Pharma
Introduction To QA in Pharma
• Quality is…..
– Corresponds to a rating
– Meeting goals
– Meeting requirements
• What is Quality?
QUALITY TERMINOLOGY
• Quality Control = Correction
– ‘Quality’ & ‘Best Practice’ can be considered in terms of being ‘Fit for
Purpose’
QUALITY RELATIONSHIPS
Quality Management
Quality Assurance
GMP
Quality Control
– PACKAGING
– STORAGE
– MANUFACURING PROCESSES & PROCEDURES
– RAW MATERIALS
• Customer focus
• Leadership
• Involvement of people
• Process approach
• Continual improvement
• STRUCTURE EVALUATION
• PROCESS EVALUATION
• OUTCOME EVALUATION
MODELS OF QUALITY ASSURANCE
1. System Model
2. Input
3. Throughput
4. Output
5. Feedback
National Level
Local Level
General Approaches
• Credentialing
• Licensure
• Accreditation
• Certification
• Charter
• Academic Degrees
Specific Approaches