Quality management & GDP
Mastering great challenges with ease
Experience has shown that regulatory documentation obligations and GDP requirements in the healthcare market represent complex hurdles for many companies. Kyberg removes these obstacles in an uncomplicated way.
Professional quality management
- QM team with 5 experienced employees
- Over 35 years of experience in storage, shipping and handling of pharmaceuticals and category-related products
- Continuous optimization of function, efficiency and service quality
- Regular training and further education (SOP / work instructions)
- Periodic self-inspections
- Possibility to carry out external supplier inspections
- Implemented change control system
- Variance management (CAPA)
- Efficient processes for returns, recalls and suspected pharmaceutical counterfeiting
- Regular supplier and customer qualifications on the subject of quality management
Your advantage:
Professional quality management without creating or binding additional resources.
Professional quality management without creating or binding additional resources.
Challenges of GDP (Good Distribution Practice) for manufacturers
- Warehouse must be GDP-certified by the responsible supervisory authority (for our logistics centre: Government of Upper Bavaria)
- Strict regular inspections by the relevant regulatory authorities
- GDP-compliant quality management systems must be established along the entire supply chain and constantly monitored
- Electronically monitored and constantly guaranteed storage temperatures of 15 to 25 °C or 2 to 8 °C
- Secured refrigerated shipment of pharmaceuticals at 15 to 25 °C or 2 to 8 °C
- Participating transport companies must also be GDP-certified
- Adequate access control and alarm protection
- Effective pest control (pest detection and prevention)
- Separate areas for certain products (e.g. cytostatics, dangerous goods, etc.)
- Functional restricted and quarantine storage
- In accordance with securPharm (counterfeit protection)
- Drug approvals are time-consuming and complex - Kyberg provides competent support
Your advantage:
You benefit from efficient, GDP-compliant logistics processes and can concentrate on more important tasks.
You benefit from efficient, GDP-compliant logistics processes and can concentrate on more important tasks.
Is quality essential for the distribution of your products?
Then come to Kyberg - because we really take quality very seriously.