Typically, a licensor requests bids from multiple CMS. At the end of the tendering procedure, the contracting entity shall select a source and then, for the agreed price, the developer shall act in the same manner and on behalf of the procuring entity for the manufacture, testing, release and dispatch of materials. The basic principle is to guarantee the quality, efficacy, identity and safety of products in order to protect both the consumer and the manufacturer. Therefore, compliance with the manufacturing process is extremely important to guarantee the aforementioned characteristics and ensure that the CM can deliver its production to its consumers in a timely manner. Compliance with the manufacturing process includes: in today`s competitive environment, pharmaceutical companies are increasingly outsourcing the production of APIs and formulations. In such cases of contract manufacturing, the EU Guidelines on Good Manufacturing Practice invite companies to sign a technical agreement setting out the roles and responsibilities of the parties concerned with regard to the manufacture and control of medicinal products. A GMP technical agreement ensures compliance with current best practices (cGMP). From both a regulatory and commercial point of view, companies should cooperate with their suppliers (contract manufacturers) to ensure that they receive materials and services in accordance with established quality, volume and delivery specifications. Some companies limit the supplier qualification process to the establishment of a supplier contract. However, this approach is generally insufficient when it comes to clarifying the tasks, responsibilities and obligations of each party with regard to product quality and verification. In addition to the general business requirements to be taken into account between the Am and the CM presented in the previous chapter, compliance with cGMP is an additional condition necessary for the practice of manufacturing the pharmaceutical order, as required by Chapter 7 “Outsourced activities” of the EU-GMP. To guarantee authorisation, the GC and CM must comply with the cGMP regulation in order to guarantee the marketing of their products.
Since CMs typically use multi-purpose equipment and equipment, cleaning is a critical aspect of contract manufacturing activities. Cleaning validation can be a difficult focal point to satisfy for both CG and cm partners. In any case, the effectiveness of the cleaning must be demonstrated by the CM and a cleaning validation plan must be discussed and agreed. This document should contain the following elements: “The manufacture and analysis of orders must be properly defined, agreed and controlled in order to avoid any misunderstanding that could lead to a product or factory of unsatisfactory quality. […] The contract must clearly state how the qualified person who sells each batch of the product exercises full responsibility” (extract from the rules applicable to medicinal products in the European Union, volume 4, good manufacturing practice, Chapter 7, manufacture of orders and analysis). Under the order manufacturing agreement, the CM is compensated on the basis of the coverage of fully debited production costs, plus a margin (defined by the user). . . .