International Council for Harmonization (ICH) Q10 and Pharmaceutical Inspection Co-operation Scheme (PIC/S) Good Manufacturing Practice for Medicinal Products requires a written agreement between the contractor and the accepting contractor for outsourced pharmaceutical activities (7, 8). A quality written agreement is therefore a collective requirement in the sector, developed in consultation with a multi-functional team, to ensure that partners operate with the same guidelines (9). The collaborative development of the agreement gives a better idea of the quality systems of the CMO and the focus on quality, which will potentially pave the way for improved trade relations. Lack of clarity about the responsibilities of the PMPC can put both product owners and contract agencies at risk. The resulting scenarios, such as non-compliance, breach of contract, lack of drugs and loss of market, have direct commercial implications for both parties. This guide describes the FDA`s current thinking on the definition, implementation and documentation of the manufacturing activities of the parties involved in the manufacture of contract drugs subject to the current requirements for good manufacturing practices (CGMP). In particular, we describe how parties involved in drug manufacturing can use quality agreements to define their manufacturing activities to ensure compliance with PMCs. The labour-based production market is expected to grow at a healthy rate of 7.5% per year; Many of them are converted into wage and production organizations (5). The FDA recognizes that CDAs can improve speed, efficiency, technical know-how, knowledge and expertise (4). The guidelines will ultimately benefit patients who will be prescribed drugs manufactured at CMO sites as part of the agreement.
The illustrative cases reviewed in the guidelines are typical of CMO projects. The Agency is responsible for the fact that its product, a human, veterinary, biological, biotech drug, a drug, an in-process material or a combined product, is manufactured in accordance with the CGMP, while a quality agreement may affect the CMO to a specific manufacturing activity. The European Union guidelines also provide for the definition of outsourcing activities and the writing of a contract in order to avoid misinterpretations that could lead to poor quality (6). One measure to report is the lot acceptance rate (LAR). This metric is an effective tool for estimating the quality costs of production sites. It would reflect the actual efficiency of continuous units or production lines, where current measurement standards focus primarily on productivity figures. The LAR metric allows decision-making as part of the main management and opportunities for continuous improvement for the products. CMOs offer pharmaceutical and bio manufacturers one of the world`s most important and rapidly changing assets today: time. Outsourcing manufacturing processes allows pharmaceutical and biological manufacturers to free up the internal resources needed to prioritize internal capabilities and improve process efficiency.
Services offered by CMOs include pre-formulation, formulation development, stability studies, method development, clinical and phase I materials for clinical trials, materials for late-stage clinical trials, formal stability, scale-up, registration lots and commercial production.