The production of high-quality, safe medicinal products is the declared objective of every pharmaceutical company and is subject to GMP rules. Certain requirements must be met during transport to ensure that the medicinal products arrive at their destination intact and with no loss of quality. The rules applying to this are referred to as Good Distribution Practice (GDP).
A central topic in this regard is the supply chain integrity. A tight knit distribution chain and the shipment traceability associated with it should effectively prevent the entry of falsified medicinal products into the legal supply chain.
Another key issue involves maintaining and monitoring specified temperature ranges during the transport, since irreversible damage to the quality of the medicinal products may result from exceeding both the upper and lower temperature limits. (Christoph Frick, PhD, Nicola Spiggelkötter, PhD)
The topic of transporting medicinal products is addressed in numerous national and international regulatory structures. However, at present there are no sets of regulations that deal with all critical aspects. Moreover, the rules are often kept at a very general level.
Specific information on the topic of "transport and temperature" can be found, for example, in the USP monograph <1079>, in the GUIDE-0069 of the Canadian healthcare authority and in PDA Technical Report No. 39.
One can draw the conclusion from the EU GDP Guidelines that classic elements of a QA system such as training, deviation and change control, CAPA and qualification and validation will continue to play an important role in the field of pharmaceutical transports in the future. (Christoph Frick, PhD, Nicola Spiggelkötter, PhD)
The designations given in pharmacopoeias and relevant regulatory guidelines for different storage conditions and the temperature ranges pertaining to them are not uniformly defined. However, for transport purposes they can be classified as transports at ambient temperatures (15°C to 25°C), at refrigerated or chilled temperatures (2°C to 8°C) and at freezing temperatures (–15°C to –25°C). To maintain ambient temperatures, air conditioning or climate control of the vehicles, trailers etc. is acceptable. For refrigerated transports it is necessary to utilize active cooling units in vehicles or containers or to use passive shipping containers, respectively. For frozen transport, the use of dry ice is a must. (Christoph Frick, PhD, Nicola Spiggelkötter, PhD)
For transports at ambient temperature and for refrigerated transports active vehicles (such as trucks with refrigerated semi-trailers), active shipping containers (primarily for air freight) as well as passive boxes can be used.
Active cooling systems are understood to be cooling systems that provide temperature control on the basis of energy input (electricity/battery) from the outside. Passive systems on the other hand function autonomously without energy input from outside sources. The temperature control here is provided by cooling elements that contain different cooling media.
Refrigerated semi-trailers use cooling units for temperature control. The air circulation in the freight compartment is decisive for uniform temperature distribution. Actively temperature-controlled containers with dry ice cabins are in widespread use for air freight. In addition, there are also containers equipped not only with a compressor for cooling, but also with a battery for generating heat. Coolers, thermal boxes and insulated boxes are available for transport in passive shippers and boxes. (Christoph Frick, PhD, Nicola Spiggelkötter, PhD)
Due to a lack of specific regulations, requirements for transporting medicinal products by road are oriented towards quality standards for the carriage of foodstuffs. Aside from the HACCP, the stipulations of the ATP Agreement for the carriage of perishable foodstuffs are particularly important here. The IATA regulations, which apply to air cargo, also include guidelines on handling time- and temperature-sensitive health care products. However, it is extremely difficult to provide comprehensive training in and heighten awareness of the topic of "temperature-sensitive medicinal products" in the air cargo sector. This is also true for validation of the transport process. (Christoph Frick, PhD, Nicola Spiggelkötter, PhD)