With the publication of the European Good Distribution Practices (GDP) guideline in 2013, to better protect the pharmaceutical supply chain, all actors in the pharmaceutical supply chain are obliged to perform a full review of all associated quality management systems to determine current compliance status, as well as address gaps, thus ensuring compliance in accordance with the guideline.
A risk-based approach is essential for creating a practical supply chain security standard for all supply chain partners. The GDP guideline recommends all actors in the supply chain adapt such a risk based approach when referring to the ICH Q9 Quality Risk Management standard (EMA/CHMP/ICH/24235/2006).
The transparency regarding the supply chain is a key element to fully understand the supply chain routes including potential associated risks. Furthermore, responsibility of each party involved in the distribution activity should be clearly defined in the written agreement and understood by all parties involved within the supply chain routes.
The following questions may be answered to fully understand the supply chain routes:
- who is responsible for the supply chain for a certain step in the distribution process;
- what are the specific roles determined as part of the contract;
- who is dealing with whom;
- from whom are we buying;
- to whom are we selling?
Supply chain complexity and associated risks should be considered and documented in a risk assessment. Sequential supply chain issue management such as, but not limited to, temperature excursions, damages management, intermediate storage activities need to be identified and responsibilities assigned.
Although it is recognized that sensitivity to humidity and or light are also important aspects of transportation conditions, the risk of product deterioration because of high humidity or light exposure is considered low because packaging is developed with the intent to protect product during storage and distribution. The risk assessment should provide the answer on the required means to ensure the “correct range of temperature” during the transportation route to avoid impact on product quality. A simple yet effective schematic of how to follow through a risk assessment to determine appropriate supply chain routes and shipping (temperature) conditions, that can be applied to active pharmaceutical ingredients and medicinal products is shown on Figure 1 below.
Figure 1. Diagram of a risk assessment process to determine appropriate supply chain routes and shipping conditions (reference: APIC statement on Good Distribution Practices, Active Pharmaceutical Ingredients Committee, March 2019).
