When it comes to the transit of pharmaceuticals, public safety is of paramount importance. In 2013 the European Commission published updated guidelines on Good Distribution Practice (GDP) of medicinal products for human use in the form of a Commission Guideline (2013/C 343/01).
The uniformity of the temperature in the load area have to adhere to complex standards, managed in the UK by the MHRA (the Medicines and Healthcare Products Regulatory Agency) to protect the quality and integrity of medicinal products which can be affected by a lack of adequate control of temperature, hygiene and security. The GDP guidelines ensure that the drugs are transported and stored at the correct temperatures, as specified on the packaging.
Sadly, the regulations don’t provide a ‘check list’ for companies to follow. They only outline the actions and measures you have to take to adhere to the strict temperature conditions. We have invested significant time and resources into understanding the requirements and the vehicles we convert meet GDP guidelines.
Strict inspections are carried out by MHRA to ensure companies are complying with the regulations and punishments include fines and suspension or revocation of licences. MHRA inspectors can visit multiple depot sites and multiple visits, and can come unannounced. If kept outside of the recommended temperatures for any length of time, the drugs degrade, making them less effective and potentially harmful to the consumer. If a deviation of temperature has occurred during transportation, this should be reported to both the distributor and the recipient.
Pharmaceutical distributors should consider the length, time and complexity of each journey. It is their responsibility to ensure that the required storage conditions are maintained during transportation within the defined limits as described by the manufacturer or on the outer packaging of the product.
Other factors for consideration include managing the risk of contamination, temperature mapping and air circulation within the vehicle, weather and multiple drop-offs, security, cleanliness and driver training.
The process of transportation should be supported by written procedures, form part of the self-audit programme and be subject to risk assessment.
Our sales team is fully trained in specifying refrigerated vehicles fit for purpose within the pharmaceutical industry, with a proven track record of existing customers currently benefitting from a CoolKit conversion. Speak to us today on 01282 770023 or request a meeting via email at firstname.lastname@example.org