Descrição
CONTENTS:
Management and Supervision Responsibilities
Quality Risk Management
Knowledge Management and Organizational Learning
Quality Management and Quality Systems
Product and Process Monitoring
Discrepancy Observation and Investigation
Complaints
Qualification and Validation
Learning, Training and Performance
Documents, Records and Recordkeeping
Change Management
Corrective Action and Preventive Action(CAPA)
Materials and Packaging Components
Vendors, Third Parties, and Outsourcing
Sampling
Sample Preparation and Analysis
Testing and Analysis/QC Laboratory Operations
Equipment Cleaning
Sanitation
Facilities and Utility Systems
Warehousing and Storage
Distribution Practices
Maintenance, Repair, and Calibration
Materials Receiving
Equipment
Manufacturing and Packaging: GMP Concepts
Manufacturing and Packaging: Operations
Identity Control
Label Control
Batch Release
In-process Controls
Aseptic Processing
Clothing and Personal Hygiene
