Sofrigam defines three steps to GDP pharma cold chain compliance

Rueil Malmaison, France: – The cold chain logistics of pharmaceutical products require special precautions to ensure their efficacy and safety for patients and compliance with Good Distribution Practice (GDP) is a regulatory requirement for pharmaceutical companies and their subcontractors.

Sofrigam has enlisted advice from Olivier Mary, expert in pharmaceutical and biopharmaceutical transport and logistics, to define how the GDP requirements should be met and define a three-step initial procedure.

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.

“As time moves on, the more the regulations for the transport of medicines and heat-sensitive healthcare products will become clearer,” says Olivier Mary, who is Director of Pharmaceutical and Logistics Development at Lyon-based COLCA Medical & Scientific, a bespoke pharmaceutical custodian, batch importer-certifier, clinical, ATU and commercial secondary packaging operator.

Guidelines on Good Distribution Practice were first established in 2000 and a full European version was published in the Official Journal of the European Union on March 7, 2013, for implementation in June 2014 across the EU.

“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,” M. Mary comments.

Cold chain distribution requirements

GDP is a regulatory requirement for pharmaceutical companies. Within the EU, responsibility always lies with the starting point of the medicine, the manufacturer. If any problems emerge in the distribution chain, the manufacturer of the medicinal product assumes responsibility, not the carrier or the distributor.

As M. Mary explains: “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 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,” M. Mary emphasises.

Temperature control requirements apply to cold chain products, storage and transport. The client must be able to obtain confirmation from service provider that all 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 GDP Guidelines. Within this, there are two extremely important sections devoted to verification of transport and validation of healthcare product packaging that Sofrigam will explore in future bulletins.

Controlling the medicine cold chain across the entire network: three key steps

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., who defines three initial steps that must always be observed:

Step one: Qualification of cold chain equipment
All equipment contributing to the temperature control of pharmaceutical products across the supply chain must be qualified prior to shipping, during shipping and on arrival of the products. This includes refrigerated cabinets, cold rooms, insulated packaging solutions, etc.

Step Two: Qualification of transport conditions and service
Operational teams must also be qualified and 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.

Step Three: Analyse transport conditions
The objective is to prepare a route analysis which must be as accurate as possible in terms of transport conditions, considering 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.

Audited solutions provider

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.

About Sofrigam

With over 40 years of experience, Sofrigam provide a comprehensive portfolio of innovative packaging and related solutions that allow pharmaceutical and other clients to optimize their temperature-controlled logistic chains.

From its French roots, Sofrigam has become a global company, operating in the USA, Canada, UK and across Europe, with manufacturing centers in North America and Europe.

Sofrigam manufactures a range of standard and made-to-measure thermal packaging products, including cartons, cases, bags and pouches that cover every step in the cool chain, from manufacturer to end-user.

It also offers customized services designed to achieve secure, cost effective and ecological cold chain logistics in shipping, storage and packaging.

Sofrigam Services accompany clients through every step of the logistics chain while prioritizing safety of goods and reducing costs. Advanced software and other solutions allow clients to audit their cold chains, monitor shipments, analyze logistics lanes, manage Inventory and optimize ordering.

Sofrigam can also deliver best Time to Market through thermal simulation equipment combined with its ‘cut & glue’ customization process that gives customers the ability to adapt any catalog product to its own needs with development time reduced to as little as 15 days.