A GDP-compliant pharmaceutical cold chain in 3 key steps
Good Distribution Practice: from recommendations to requirements
The aim of GDP is to maintain the quality of healthcare products at all levels of the distribution network so as to ensure the quality and integrity of medicines up to the final link in the chain.
“Guidelines on Good Distribution Practice were established in 2000. At the time, there were just a few pages. The recommendations on the transportation of medicines for human use were succinct and the concept of maintaining constant temperatures rarely addressed”, says Olivier Mary.
A new European version was published in the Official Journal of the European Union on 7 March 2013 for implementation in June 2014 in France.
“These new GDP guidelines follow on from the previous rules, but the requirements have been enhanced with regard to the quality system and defining the means to ensure the security of medicines across the entire distribution network,” he adds.
“As time moves on, the more the regulations for the transport of medicines and heat-sensitive healthcare products will become clearer,” says Olivier Mary.
What are the requirements for cold chain distribution?
Temperature control requirements not only apply to cold chain products but also storage and transport. GDP is a regulatory requirement for pharmaceutical companies, as explained by Olivier Mary, “it is the client, or rather the pharmaceutical company, which transposes its requirement level onto its service providers, whether they are carriers, wholesale distributors or manufacturers of cold chain equipment, through its specifications. The rights, duties and obligations of each must be clearly defined and included in the specifications”.
The client must be able to find the information from its service provider demonstrating that the premises, equipment and vehicles used for distribution, storage or handling products are adapted to the storage conditions for healthcare products required in the MA, which are referred to in annex 15 of the Guidelines on Good Distribution Practice. Within this, there are two extremely important sections devoted to verification of transport and validation of healthcare product packaging.
- We will go into more detail on these two sections in the GDP guidelines in our next article
Within the European Union, responsibility always lies with the starting point of the medicine, i.e.the manufacturer. If any problems emerge in the distribution chain, the manufacturer of the medicinal product assumes responsibility, not the carrier or the distributor.
“The pharmaceutical company is expected to monitor and control the distribution chain up to the pharmacy. This is why full control of the process is mandatory,” says Olivier Mary.
Controlling the medicine cold chain across the entire distribution network: 3 initial key steps not to overlook.
Controlling the distribution network means having visibility across the entire logistics chain, and incorporating a « risk analysis » and « quality monitoring » approach.
“The medicine leaving the production site must be compliant. Upon delivery to the pharmacy, its conformity and integrity must be retained until it reaches the patient”, says Olivier Mary.
- Qualification of cold chain equipment.
This concerns qualifying all equipment contributing to the temperature control of pharmaceutical products across the supply chain (prior to shipping, during shipping and on arrival of the products). This includes refrigerated cabinets, cold rooms, insulated packaging solutions, etc.
- Qualification of transport conditions and the transport service itself.
This requires qualification of the operational teams which must be trained on the management of heat-sensitive products prior to departure, during transportation and on arrival of the products. Care should be taken to ensure that the equipment used is adapted and specially designed to maintain the constant temperature of products throughout the distribution network.
- Transport conditions.
The objective is to prepare a route analysis which must be as accurate as possible in terms of transport conditions, taking into account seasonal variations. « Trial » shipment runs can also be carried out, depending on the risks determined by the client.
“Suppliers and carriers must be in step with the regulatory constraints of pharmaceutical manufacturers. This is why pharmaceutical companies must provide specifications that are as clear as possible and perform regular audits on their suppliers,” says Olivier Mary.
Sofrigam is regularly audited by its pharmaceutical clients to verify that the quality and the efficiency of insulated packaging solutions, as well as the quality management process meets their requirements in terms of product stability and ensure that they fully conform with GDP regulatory requirements. Sofrigam offers qualified insulated packaging solutions in accordance with the highest standards.
Sofrigam’s technical teams are also able to assist pharmaceutical companies in writing precise specifications on the choice of a‘GDP-compliant’ insulated packaging solution.