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 in
the pharmaceutical, medical and biotechnological industries, the CROs
(Clinical Research Organizations) and clinical laboratories, the pharmaceutical distribution.
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"Draft Guidance for Industry, Stability Testing of Drug Substances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.
"Guidelines on Good Distribution Practice of Medicinal Products for Human Use", EMEA 94/C63/03.
Good Storage and Shipping Practices - General Chapters, USP Chapter <1079>.
"Good Practices of Distribution(Control and Monitoring of Storage and Transport
Temperature: Information Letter",
UK-MHRA, Letter N°131.
"Guide to Good Storage Practices for Pharmaceuticals", WHO Technical Report Series, N°908.
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Pharmaceutical Industries
