Certicold Pharma Presentation of the label Annick DEMOUY President of the committee of labelling Certicold Responsible pharmacist Stradis This Document is the property of Cemafroid SAS, and cannot be used nor given to outside party without prior authorization.
SUMMARY ° Pharmaceutical context ° The Certicold Pharma Solution ° The labelled products ° Why choose Certicold Pharma? ° Mode of labelling ° Who is issuing the label? This Document is the property of Cemafroid SAS, and cannot be used nor given to outside party without prior authorization.
Pharmaceutical context ° Regulations strengthened for the preservation of the temperatures of the health products : – Obligation of results: Need to choose appropriate means to achieve results; Demonstrate that these means are adapted … ° But – Absence of public specifications, independent label and third party device. ° Need for an independent certification of cold chain equipment in Europe. This Document is the property of Cemafroid SAS, and cannot be used nor given to outside party without prior authorization.
The Certicold Pharma Solution ° A European conformity label – For European equipment in the cold chain of health products, – Created by professionals for professionals. ° Managed by an independent committee of labelling; – College of Healthcare Professionals – College of Equipment Manufacturers; – College of Independent Experts; – College of Administrations and Supervisory Authorities. ° A conformity with the GDP and with the recommendations of the order of the pharmacists. This Document is the property of Cemafroid SAS, and cannot be used nor given to outside party without prior authorization.
The labelled products ° Today the label covers 2 types of equipment: – The vehicles of transport of health products – Isothermal or refrigerant packaging solutions for health products This Document is the property of Cemafroid SAS, and cannot be used nor given to outside party without prior authorization.
The labelled products ° Other equipment related to the cold chain is being studied : – Thermometers and temperature recorders – Climatic and thermostatic enclosures This Document is the property of Cemafroid SAS, and cannot be used nor given to outside party without prior authorization.
Why choose Certicold Pharma? ° For performances validated and corresponding to the regulations and applicable standards – GDP, WHO, ATP, FD X 15140, NF S 99700, marking CE, norms CEN, Afnor or DIN, etc. ° For equipment integrating the latest technologies – Latest technical advances – Innovation in the control of the cold chain. ° For a conception that meets the expected functionality – Preservation of the current temperatures, control of energy – Mechanical resistance and durability … This Document is the property of Cemafroid SAS, and cannot be used nor given to outside party without prior authorization.
Why to choose Certicold Pharma? ° For the constant quality of the equipment – Control of quality management system – Tests at regular frequencies ° For a fair price – Comparison of prices on an objective basis This Document is the property of Cemafroid SAS, and cannot be used nor given to outside party without prior authorization.
Mode of labelling Applicant’s Unit Anonymous Decision of Application Application annual verification synthesis labelling file analysis audit by type test (Tests + Audit) Committee of Cemafroid Cemafroid Applicant Cemafroid Cemafroid labelling Certificate of type delivered by Cemafroid This Document is the property of Cemafroid SAS, and cannot be used nor given to outside party without prior authorization.
Who issuing the label? ° The committee of ° Manufacturers – Vehicle of transport, Packagings… labelling Certicold ° – Chaired by Doctor Users Annick DEMOUY : – Pharmaceutical companies, Distributors, Carriers … Quality insurance ° manager - STRADIS Administrations and bodies of laboratory control – Mr Guy THOMAS, vice- – DGAL, DGS, DGCCRF president : ° Experts Cold technical director – Test laboratories, independent of Petit Forestier group experts… This Document is the property of Cemafroid SAS, and cannot be used nor given to outside party without prior authorization.
Who is issuing the label? The committee of labelling Certicold Manufacturers Users Administrations and bodies of control Experts This Document is the property of Cemafroid SAS, and cannot be used nor given to outside party without prior authorization.
How to know if an equipment is labelled? ° To consult: – The detail of the certified characteristics, – The list of the certified products Certicold Pharma ° Log on: www.certicold.fr This Document is the property of Cemafroid SAS, and cannot be used nor given to outside party without prior authorization.
° Annick DEMOUY President of the committee of labelling Certicold Responsible pharmacist Stradis Laboratory This Document is the property of Cemafroid SAS, and cannot be used nor given to outside party without prior authorization.
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