Presentation of the label Annick DEMOUY President of the committee - - PowerPoint PPT Presentation
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
This Document is the property of Cemafroid SAS, and cannot be used nor given to outside party without prior authorization.
This Document is the property of Cemafroid SAS, and cannot be used nor given to outside party without prior authorization.
This Document is the property of Cemafroid SAS, and cannot be used nor given to outside party without prior authorization.
– Obligation of results:
Need to choose appropriate means to achieve results; Demonstrate that these means are adapted …
– Absence of public specifications, independent label and third party device.
This Document is the property of Cemafroid SAS, and cannot be used nor given to outside party without prior authorization.
– For European equipment in the cold chain of health products, – Created by professionals for professionals.
– College of Healthcare Professionals – College of Equipment Manufacturers; – College of Independent Experts; – College of Administrations and Supervisory Authorities.
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.
This Document is the property of Cemafroid SAS, and cannot be used nor given to outside party without prior authorization.
This Document is the property of Cemafroid SAS, and cannot be used nor given to outside party without prior authorization.
and applicable standards – GDP, WHO, ATP, FD X 15140, NF S 99700, marking CE, norms CEN, Afnor or DIN, etc.
– Latest technical advances – Innovation in the control of the cold chain.
– 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.
This Document is the property of Cemafroid SAS, and cannot be used nor given to outside party without prior authorization.
Cemafroid
Unit verification
by type test
Applicant
Application file Application analysis
Cemafroid Committee of labelling
Decision of labelling
Cemafroid
Applicant’s
annual audit
Certificate of type delivered by Cemafroid
Cemafroid
Anonymous synthesis
(Tests + Audit)
This Document is the property of Cemafroid SAS, and cannot be used nor given to outside party without prior authorization.
Quality insurance manager - STRADIS laboratory
Cold technical director
Manufacturers
– Vehicle of transport, Packagings…
Users
– Pharmaceutical companies, Distributors, Carriers …
Administrations and bodies of control
– DGAL, DGS, DGCCRF
Experts
– Test laboratories, independent experts…
This Document is the property of Cemafroid SAS, and cannot be used nor given to outside party without prior authorization.
The committee of labelling Certicold
Users Administrations and bodies of control Experts Manufacturers
This Document is the property of Cemafroid SAS, and cannot be used nor given to outside party without prior authorization.
This Document is the property of Cemafroid SAS, and cannot be used nor given to outside party without prior authorization.