Alternatives Technologie Pharma provides unique
Cold Chain packaging and monitoring solutions in order to ensure the cold and temperature chain control in
community and hospital pharmacies, hospitals, clinical laboratories, blood banks, human cell and tissue banks.
Our Cold Chain Services and Solutions Package enables to comply with:
Chapter 42 - "Blood and Blood Products - Inspection of Licensed and
Unlicensed Blood Banks, Brokers, Reference Laboratories, and Contractors" , US FDA.
Chapter 56 – "Drug Quality Assurance - Inspections of Licensed Biological
Therapeutic Drug Products" , US FDA.
21 CFR PART 606 "Current Good manufacturing Practice for Blood and Blood Component" , US FDA.
21 CFR PART 1271 "Human Cells, Tissues and Cellular and Tissue-based Products" , US FDA.
American Association of Blood Banks (AABB) Accreditation and Standards .
American Association of Tissue Banks (AATB) Accreditation and Standards .
"Standard for Hematopoietic Progenitor Cell Collection, Processing & Transplantation" ,
Foundation for the Accreditation of Cellular Therapy (FACT).
"Blood and blood components" , Canadian Standard Association (CSA): Z902-04.
"Guidelines for Temperature Control of Drug Products during Storage and Transportation" ,
(Guide-0069), IDGPSA, Health Canada.
Chapter 1079 - "Good Storage and Shipping Practices - General Chapters" , USP .
|
Pharmacies & Healthcare Institutions
