Recommendations concerning the transport of health care products under controlled temperatures
Good Manufacturing and Distribution Practices
Within the framework of their public health responsibilities (articles R. 5124-36, R. 5124-48, R. 5121-23 and L. 5124-2 paragraph 2 of the Public Health Code, Good Manufacturing and Distribution Practices, etc.), pharmaceutical establishments must provide a high level of quality in the manufacturing of health care products for dispensing to patients.
Improve the quality of transport operations
In particular, certain health care products must be kept at 5°C +/- 3°C under the terms of their Marketing Authorisations (MA). This obligation applies from the manufacture of the product until its dispensing to the patient, which thus covers transport and defines the cold chain.
However, the transport of these products (referred to as transport under controlled temperature) is generally sub-contracted to logistical carriers who are not necessarily pharmaceutical establishments, but must allow the Pharmacist in charge of the shipping establishment to exercise his committed responsibility.
Moreover, the volume of products to be kept at 5°C +/- 3°C (vaccines, products in investigation, biotechnology products, etc.) is rising substantially.
The National Order of Pharmacists therefore considered it necessary to formalize for carriers a precise and homogeneous vision of the technical and regulatory constraints of pharmaceutical
establishments in this field in order to improve the quality of these transport operations and the level of observance of these requirements.