Validation of temperature controlled storage & distribution
Nowadays global regulatory agencies focus on the entire pharmaceutical supply chain. Pharmaceutical manufacturers and distributors are obligated to guarantee that their products get to the patient, under the required temperature conditions. To demonstrate compliance, qualification and validation of essential components is a must.
Medicines are susceptible to variations in ambient temperature during their production and distribution processes. This can greatly affect the quality of the pharmaceuticals. Therefore, the logistics and distribution of medicines is subject to strict regulations (GDP 2013/C).
On of the biggest challenges is the revised GDP guidelines is that the product must remain within the provided specifications throughout the entire supply chain. This pretains to both chilled products and products which should be stores at room temperature. Any deviations to this should also be treated appropriately. Agidens Life Sciences can support you in both the qualification and validation of this.
Validation of the entire transport chain
Agidens offers manufacturers of pharmaceuticals and medical devices and specialised transport companies an integrated solution for transport validation or cold chain validation.
- Mapping cold spots and hot spots
- Impact of worst case scenarios on the basis of alarm simulations
- Impact analysis of temperature increase on cargo
- Influence of outside temperature
- Validation software
- Correlation between monitoring system and actual temperature distribution
- Mapping the fleet
- Validation of temperature tracking system
- Correlation between lorry temperature and monitor temperature
- Load and design advice
Refrigerators, ovens, incubators, freezers, -80°C – freezers, temperature control fridges
Why Agidens for transport & cold chain validation?
We excel in performing qualification and validation activities, and have properly trained, experienced subject matter experts who can perform all required services and who can also create/review validation documents in compliance with the appropriate guidelines.
- Specialist in logistics processes and the management of supply chains..
- Specific knowledge about (thermal) Validation & Compliance.
- Our Energy & Sustainability consultants can advise you immediately in setting up an energy efficient transport chain.
- Large team of more than 80 compliance professionals
- FDA – EU compliancy (US and EU teams)
How can we help?
Is it Agidens Life Sciences you’re looking for? We’re eager to hear your questions or challenges.