As we have presented in our first blog series, the regulation and control of medicinal products has been covered by Good Manufacturing Practices (GMP). However, the quality of these products can be negatively affected by a lack of control over the supply chain process. In addition, applying principles designed for the pharmaceutical industry to companies of a different typology has caused specific difficulties of a certain severity. This has led to problems in the interpretation of the rules between the different parties involved, and the resulting difficulties in communication.
Distribution networks for medicinal products have become increasingly complex, with the involvement of many players, especially since the rise of globalization in the 1990s. Technological advances in the logistics sector have allowed production factors to be relocated at a global level, allowing costs to be lowered without compromising products’ quality and safety. The main problem that has arisen from these change is that the control over the logistics chain has become much more complicated, especially taking into account the characteristics of the products, which can be sensitive to heat, humidity and light in many cases.
In practice, companies’ Qualified Persons (QPs) did not have an adequate degree of control and information about what was occurring in the supply chain. However, they had to answer to the health authorities for incidents, and also during inspections. These were issues that were often unknown, and suddenly the supply chain had to be identified, controlled and monitored. And it was necessary to make people who are experts in pharma understand with people who are experts in logistics. It was a real challenge.
This is the main reason why Good Distribution Practices (GDP) were created, seeking to align requirements and facilitate compliance with regulations, always with the aim of ensuring the safety, quality and traceability of the products throughout the integrated supply chain.
EU GDP was initially published in 1994 (94/C 63/03). This version was finally updated in 2013 (2013/C 343/01), and applies both to the wholesalers and manufacturers of pharmaceuticals, and also incorporates requirements for the brokers dealing with pharmaceutical products.
In 2015, the European Comission released the principles of Good Distribution Practices of Active Substances for Medicinal Products for Human Use (2015/C 95/01) for importers and distributors of active substances for medicinal products for human use.
In the US, The United States Pharmacopeia (USP), covers the good storage and distribution practices across two chapters:
• Chapter 1079: Good Storage and Distribution Practices for Drug Products.
• Chapter 1197: Good Distribution Practices for Pharmaceutical Excipients.
A new chapter (USP<1083>) was introduced to serve as an all-embracing chapter, and covers a wider range of products.
The improvement of quality standards adopted by raw materials suppliers in countries like India and China, together with competitive prices and reduced transport costs, has led to an increase in the number of companies importing products and active ingredients from overseas suppliers, leading to a previously inexistent risk in the products’ safety. In this regard, technology can be useful to reduce risk and improve the degree of control and traceability, but it can also be a threat and a risk factor to be taken into account in the future.
In the upcoming entries we will analyse the regulatory bodies’ point of view, including examples found in inspections, the key elements of GDP, the trends and challenges for the future and how an effective audit system can be helpful to manage and control the complete supply chain. Outsourcing means loss of direct control over products and processes, and the introduction of new risks into the supply chain. These risks can be reduced to acceptable levels through the use of quality indicators, establishing controls during the process and, especially, through supplier audits.