GDP processes (Good Distribution Practice)
CSO Pharma offers professional advice and support to implement necessary GDP processes based on internal specifications and legal requirements.
Our competencies cover especially individual development, practicable realisation and successful implementation of corresponding processes.
Wholesale license (Grosshandelserlaubnis Germany)
- Analysis of existing structures
- Preparation of action plans including corrective actions, CAP
- Initiation, correspondece with authorithies, project management
- GDP System according to regulatory requirements
We also support you with corresponding basis- and expert training.
Implementation of GDP processes
- Set-up and development according to the company structures
- GDP responsible person, job descriptions
- Improvement of existing system
- Preparation or optimisation of SOPs and process descriptions
- Check lists
- Creation and maintenance of QM manual
- Site Master File
- Storage / warehouse and transport
- Qualification and validation
- Implementation training system
- Integration of supplier- and customer evaluation
- Corrective- and preventive actions (CAPA)
- Supplier management
- Risk management
GDP audits and inspectionss
- Support of internal and external audits
- Inspection readiness
- Monitoring of compliance
Come to us for professional advice. We are looking forward to your enquiry.