GDP Goes International

Good Distribution Practice is a global matter. In March 2013 the EU GDP Guideline was published and this led to controversial discussions. Applying a more global approach it becomes apparent that this guideline is one small contribution among others (WHO, USP, Canada): For example, the revised USP 36 especially chapter 1079.

What are the joint efforts of all these guidelines that focus on the quality of the supply chain? We see two overall principles: temperature and qualification.

Aspect 1 Temperature: The transport of medicinal products should be executed respecting the labeled conditions of the product. This implies in the majority of cases storage conditions are the same as transport conditions. For cold chain products common and accepted procedure, no debate about that. For ambient products, products that ask for +15°C to +25°C, general practice when we talk about storage, but a most recent development when the same temperature requirement are transferred to transportation. When we proceed along the pharma supply chain, shipments from the pharmaceutical manufacturer to the wholesaler consists of palletized consignment, mostly full truckloads. In this segment, conditioning of trailers to ambient conditions is easy to realize, including the implementation of monitoring devices that assist in providing evidence that temperature requirements have been respected in transit. Proceeding further on the road of medicinal product to its final destination, the patient, shipments from wholesalers in the local pharmacy, are the next step. The local distribution, the last mile, when we take this term literally, is done with small vehicles, very often not equipped with any equipment to condition the load. The key question, subject of great controversy in Europe: do the delivery parties have to provide conditioning devices for all their delivery routes regardless the transit time? The EU GDP Guideline provides an ambiguous answer: a risk management approach of the delivery routes decides on which routes temperature monitoring is obligatory. This leads to misunderstandings: the evaluation of risk cannot serve as an excuse to accept anticipated deviations, it is not a "card blanche". In a more US-oriented scenario, the argumentation slightly differs from the European: MKT is here the key word, but we will not further enlarge on this topic, due to the limited space for our paper.

Aspect 2 Qualification: Equipment and premises have to be qualified, documented evidence has to be provided that they perform as they pretend to do. The qualification process is clear and more or less standardized; the technical reports of the PDA are treated as state of the scientific and technical knowledge. When we focus on the questions, is the equipment able to maintain the required temperature in all circumstances? The application of temperature profiles will answer these questions. In regard to passive cooling systems, such as insulation boxes, ISTA profiles are similar are followed. Should these or equivalent profiles be transferred when qualifying trailers and vehicles. A common basis and mutual understanding about these profiles would of immense benefit as it helps to compare the individual performance of the vehicles. Everybody involved in test business knows that test results heavily depend on the intensity of the temperature impact: 20°C or 30°C is a decisive question as performance data will be completely different. Evaluating passive boxes it is understood that test runs are executed in qualified test chambers. When we talk about larger units, trailers, test runs in climatic chambers are the exception and not the rule, as it should be.

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