Alternatives Technologie Pharma provides an
unique Cold Chain package consisting in integrated regulatory services and
environmental monitoring solutions in order to ensure the cold and temperature
chain control and compliance management during the distribution, transport
and logistics of sensitive products.
Our Cold Chain Services and Solutions Package enables to comply with:
"Guidance for Industry, Q1A(R2): Stability Testing of New Drug Substances and
Products", ICH.
"Draft Guidance for Industry, Stability Testing of Drug Substances and
Drug Products", US FDA.
"Guidance for temperature-controlled medicinal products: Maintaining
the quality of temperature sensitive medicinal products through the transportation process", PDA: Technical report N°39.
"Guidelines for Temperature Control of Drug Products during Storage and Transportation", (Guide-0069),
IDGPSA, Health Canada.
"Good Storage and Shipping Practices - General Chapters", USP Chapter 1079.
"Guide to Good Storage Practices for Pharmaceuticals", WHO Technical Report Series, N°908.
International Safe Transit Association (ISTA): Test Procedure 5B:
Focused simulation guide for thermal performance testing of temperature
controlled transport packaging; Test procedure 7D: Thermal controlled transport packaging for parcel
delivery system shipment.
American Society for Testing and Material (ASTM):
Standard Test Method D 3103-99: Thermal insulation quality of packages.
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Distribution, Transportation & Logistics
