The production of high-quality, safe medicinal products is the declared objective of every pharmaceutical company and is subject to GMP rules. Even though a medicinal product may be of impeccable quality when it leaves the manufacturing facility, during transport to the end consumer it is exposed to many influences that are beyond the control of the manufacturer and that are capable of permanently compromising the quality of the product.
Therefore, it is not surprising that “pharmaceutical transport” or carriage in accordance with good distribution practice has recently become a topic of steadily growing importance. This change in awareness can be observed in inspections by authorities and in the quality assurance departments of pharmaceutical companies.
However, the requirements made in the usual regulatory structures are not homogenous. Numerous guidelines are currently undergoing revision and new ones are being issued. For example, the revised EU GDP Guidelines1were published on 7 March 2013 and are scheduled to become effective on 8 September 2013.
Keeping falsified medicinal products from infiltrating the distribution chain is a core objective that affects the following aspects of transport processes:
However, in terms of medicinal product safety, preventing the infiltration of falsified medicinal products into the distribution chain (or the theft of medicinal products from the distribution chain) is not the only aspect of pharmaceutical transport to be considered. Another major challenge is posed by ensuring that the required temperatures are maintained during transport. The temperature influence during transport can be decisive for the quality of a preparation, as the following practical example illustrates:
Wholesale distributors often use frozen cool packs for shipments of medicinal products that require refrigeration, and they generally do so regardless of prevailing outside temperatures. The likelihood that the refrigerated medicinal product will warm up is viewed as the sole risk factor, while little attention is paid to the other extreme, namely freezing. But it is this very drop to below the temperature range of 2 °C to 8 °C that can be extremely critical. Only a few minutes of exposure of an aluminium adsorbate vaccine to below-freezing temperatures can cause irreversible damage to the product (denaturation). Failure to deal adequately with the problem therefore entails the risk of compromising the safety of the medicinal product and endangering the patient as a result. This can undermine all GMP-compliant activities of a pharmaceutical company right down to the very last few steps in the distribution chain. Increasing awareness of the topic of “transport and temperature” seems to be all the more important in light of the fact that fully one-fifth of the entire global pharmaceuticals market is occupied by preparations that are subject to cold-chain requirements - and the trend is growing.
Medicinal products subject to the cold chain are generally high-priced medicines. If workflows are not scrutinized and validated adequately, transport damage could well lead to revenue and sales losses amounting to millions. Measured against a financial risk of this magnitude, the effort involved in transport validation is reasonable and economically feasible.
Intermediate storage under a third party's responsibility may become necessary in the course of distribution, for instance on Sundays or holidays. Performing a prospective and/or retrospective qualification of a cold-storage facility is therefore also an important prerequisite for controlled storage conditions.
Several cooperation partners are usually involved in the distribution chain. However, there may be marked differences in their “GMP background” and the regulatory structures applying to them. Each one, however, is responsible for pharmaceutical safety. Coordinating a distribution chain of this nature represents a major challenge that must be met.
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 the recipient intact and with no loss of quality. The rules applying to this are referred to as Good Distribution Practice (GDP).
A main topic in this regard is supply chain integrity. A tightly knit distribution chain and the shipment traceability associated with it should prevent the infiltration 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 failure to stay within temperature limits.