The delivery of clinical trial materials (CTM) or investigational medicinal products (IMP) must be flawless because they are likely the most important elements in the drug evelopment/ discovery process.
The delivery of the temperature-sensitive chemical entity shipped in tiny quantities but frequently to the clinics/sites is crucially dependent on cold chain pre-qualified packaging.
Maintain the proper storage and handling conditions (temperature) along the whole cold supply chain.
Keep track of the temperature of storage locations across the cold supply chain.
Maintain the integrity of the supply chain’s supply of temperature sensitive products.
We ensure the patient is administered a safe product by being compliant with global regulatory and standards-based requirements such as:
Food & Drug Administration (US)-21CFR 203.32 “Prescription Drug Marketing – Drug sample storage and handling requirements
World Health Organization (WHO) – International packaging and shipping of vaccines. Health Canada (HPFB Inspectorate) – Guide 069, Guidelines for temperature Control of Drug Product during Storage and Transportation; 2005.
Health Distribution Management Association (HDMA) -Guidelines for Managing Cold Chain & Temperature Sensitive Products (2009).
ICH Q1 (R2) – Stability testing of new drug substance and product.
Thermal variability can also lead to inconsistencies in results both between and within batches. To prevent any compromise in the quality of the medicines being transported, CEBIS ensures that the required temperatures are maintained precisely throughout the entire journey.
At CEBIS USA, everybody has a clear understanding of the shared objective of supplying each patient and site with the appropriate medication, at the appropriate time and in the appropriate manner.