Regulatory Requirements of Good Storage Practice
Europe
USA
Legal Responsibilities
Good Storage Practice
Facilities and equipment
Environmental monitoring
Product handling
Maintenance
GSP
Break
GMP-based Documentation
SOPs
Maintenance of SOPs
Documentation of the work
Monitoring of the storage conditions
Computerised systems
GMP conforming Work and Behavior
Maintenance of goods
Incoming controls
Quarantine
Release
Lunch
Management of Returned Goods
Different storage
Labelling
Measures necessary
Links to other department
Break
GMP Failures and Warning Letters
Discussion
6(hours)