Temperature controlled transport, are you transporting Pharmaceuticals correctly? This is a hot topic right now, especially with the unprecedented weather we have begun to experience lately.
Are you compliant? Are you aware of the expectations of the MHRA regarding the control and monitoring of temperature during transportation?
Chapter 9 in the Rules and Guidance for Pharmaceutical Distributors 2022 (The Green Guide) part of the EU Guidelines on GDP and UK Guidance on Wholesale Distribution, covers Transportation and expectations.
The required storage condition of the medicinal product as stated by the Manufacturer on the outer packaging must be maintained during transportation, you need written procedures in place for the operation and maintenance of vehicles used to transport medication, and should there be a temperature excursion, there needs to be a written procedure in place detailing how to manage the investigation and correction put in place as necessary to prevent future issues of the same or similar nature.
It is the responsibility of the supplying wholesale distributor to ensure the packaging, transportation and handling of medicinal products are fit for use and the product doesn’t suffer any quality compromising defects.
Where passive packaging is used, is it validated? Documented? Are there written procedures on ensuring that any cool packs are reused correctly?
There is a lot to think about to get the transportation of medicinal products transported correctly while maintaining the correct temperature so the stability of the product is not affected. If you need any support in this area, give us a call at PCL, we can offer support to you/your RP’s in maintaining compliance, through monthly RP forums covering a variety of topics, including this one, and, we not only offer training, but we also offer bespoke support packages designed around your individual business needs by matching those needs with one our consultants, for further information contact us