The pharmaceutical supply chain is a complex network involving various highly specialized entities and critical processes. These operations are subject to international regulations that are becoming increasingly stringent over time to better safeguard the health and safety of patients when pharmaceutical products reach the market. Such changes can lead to a resource and cost burden if industry entities fail to consolidate over time and adequately respond to new quality standards. In this article, we will focus on the key elements that pharmaceutical companies need to enhance the quality of their products and services, maintain competitiveness, and adhere to international regulations.
A Solid Network of Partnerships
One of the most crucial aspects for a company operating in the pharmaceutical supply chain is the network of partnerships at various levels. In order to ensure consumer safety, a pharmaceutical company have to provide qualified services and employ dedicated resources to deal with the he complexity of the market and the constant tightening of international regulations governing the industry. A pharmaceutical company must efficiently manage activities like ensuring the procurement and/or production of raw materials, customizing logistics services, understanding regulatory requirements and engaging with institutional organisations to allow or simplify marketing authorization, while collaborating with third party companies and sharing project objectives with them. This enables companies to promptly respond and adapt to industry crises and changes, and to adopt long-term purchasing strategies.
For example, Flarer adopts consolidated partnership strategies throughout the pharmaceutical supply chain, starting from obtaining import licenses. With its extensive experience and a global partner network, Flarer has secured all necessary authorizations to supply its customers with raw materials imported from countries outside the European Union, delivering them directly to their production sites. This advantage streamlines the procurement process, as customers do not need to request additional licenses and authorizations from competent authorities, resulting in significant time and cost savings.
During the distribution process, pharmaceutical logistics play a crucial role. An efficient supply chain must rely on transportation and storage services in line with Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) defined by international regulatory agencies. These standards ensure that the quality of pharmaceuticals is perserved throughout the supply chain, from the manufacturer’s site to pharmacies or authorized entities providing medicines to the public. This objective is achieved through innovative drug and batch traceability systems, appropriate temperature storage and maximum efficiency in terms of transportation times and costs.
A reliable logistics partner must have years of experience in the pharmaceutical sector and be capable of addressing the industry’s evolving challenges, such as the growing frequency of orders and shorter response times, especially for particularly urgent orders. Additionally, they should provide tailored solutions through efficient management and global warehouse localization. In Flarer‘s case, customers can rely on a partner with agreements with specialized transport companies and GDP-certified warehouses located in Switzerland, Germany, and Italy.
Maintaining quality standards is an ongoing objective that must be guaranteed over time through periodic audits. Every pharmaceutical industry supplier must undergo strict controls through direct and indirect inspections conducted by authorized agencies on various aspects, including:
- Production facilities and spaces;
- Equipment, in terms of operation and maintenance;
- Personnel adaptation and management, including GMP training;
- Workflow management and quality control practices;
- Documentation in terms of GMP compliance, security and proper archiving.
Corporate organization, production sites, warehouses, and the entire product lifecycle are monitored through auditing processes that qualify suppliers and enable clients to approve them, enabling them to promptly meet their needs. Additionally, qualification processes through audits verify that potential partners maintain compliance with quality standards imposed by global regulatory bodies, safeguarding consumer health.
In this case, Flarer provides a team of highly specialized experts, including Qualified Persons, Quality Assurance, and Regulatory Affairs professionals, who assist customers throughout the necessary steps in the supplier qualification process, leading to the issuance of final audit reports.