About the course:
Good Storage Practice (GSP) course addresses good storage practice in the wide sense covering all the practices that ensure that storage is planned, performed, monitored, recorded and reported in an organized and controlled manner.
The course provides training in the principles of good storage practice for personnel of warehouses who wish to the work by GMP/GDP practices.
The course addresses the requirements of WHO TRS N908, 2003 & EC- Directive 2001/83/EC; Directive 2011/62.EU.
Who should attend:
The course is designed to pharmaceutical, wholesale turnover of stocks employees, managers and control assurance personnel.
Certificates of completion are given to course participants upon successful graduation.
Course program:
The course covers following topics:
- Quality Assurance of medicines in “life cycle”
- GMP / GDP + GSP – basic requirements
- Quality management system in industry, the wholesale warehouses
- Staff – role, functions, safety, training
- Warehouses – facilities (structures), devices, and equipment (temperature control, software, training, validation etc.)
- Medicines turnover – primary processes (suppliers / buyers, receive, storage, isolation, destruction, omission, etc.)
- General requirements documents (SOPs, quality manual etc.)
- Transportation of medicines (machinery, technical equipment, devices, packaging, labeling)
- Reviews, complaints and recall
- Contracts
- Internal audit
- Requirements broker
- Audit (types, personnel, documentation, implementation, reports and results)
Course Manual:
The course comes with a comprehensive manual, which proves to be an excellent handout and source of reference after the course.