Outsourcing or decentralisation
Explanation of the term
The term outsourcing can be understood as a business strategy in which individual services, sub-areas or business processes of a company are outsourced to suppliers and are no longer performed or handled by the company itself. This often means that costs can be saved in the areas of production, development and service. A further advantage arising from outsourcing is the strengthening of the company's strategic market position. Companies can achieve cost advantages by focusing on their core business through the corresponding outsourcing to third parties. In particular, quality can be optimised through the use of professional service providers.1
Why outsource?
The outsourcing of processes in the field of pharmacy and biotechnology plays an increasingly important role for the quality of the product and for patient safety. The services affected by outsourcing range from the manufacture of medicinal products and research to logistics and distribution. External partners are often able to carry out specific tasks and processes within the scope of their core competences more effectively, more efficiently and more innovatively. However, outsourcing processes does not only bring advantages. In addition to the handling of the outsourced processes themselves, the choice of service provider or supplier also entails a high risk. Ultimately, product responsibility always lies with the pharmaceutical or biotechnological company. It must therefore ensure that the production, testing, storage and logistics of a pharmaceutical or medical product meet all legal and regulatory requirements.2
The role of third parties
The choice of partners or third parties is of fundamental importance in this process in order to guarantee the highest possible product quality within the supply chain in the long term. Suppliers are often classified into certain risk levels in advance in order to simplify selection at a later stage. Depending on the risk level identified, companies carry out so-called on-site audits to review existing processes and data. These provide a detailed insight into the partners' systems. In this field, these on-site audits are also a legal requirement and fall under the regulatory requirements applied in the context of GMP. In addition to reviewing and supplementing existing data, audits can also promote cooperation between the company and its partner and bring to light potential for improvement.3
Document management systems for quality assurance
Quality assurance and appropriate quality management should accompany the entire life cycle of a supplier relationship and can be regarded as a fundamental prerequisite for successful cooperation with partners. Various elements of quality assurance help to make the process manageable and to ensure conformity with the GMP requirements. Besides the regulatory requirements, an important point is the precise description of the individual processes and responsibilities. Care should be taken here to consider the entire structure. Many pharmaceutical and biotechnological companies rely on special document management systems for this purpose. These often contain tools and functions that can be particularly helpful in the context of regulatory requirements and enable smooth workflow management. 4