During the First World War, manufacturing processes generally became more complex and more workers were monitored. During this period, mass production and piecework were widely introduced, which was a problem, as workers could now earn more money from the production of additional products, which sometimes resulted in the transfer of poor quality of processing to the flow legs. Pioneers such as Frederick Winslow Taylor and Henry Ford recognized the limitations of the methods used at the time in mass production and the different quality of production. Taylor, who used the concept of scientific management, helped to divide production tasks into several simple steps (the assembly line) and limit quality control to some people, thus limiting complexity. [14] Ford insisted on standardizing design standards and components to ensure that a standard product was manufactured, while quality was the responsibility of mechanical inspectors “placed in each department to cover all operations … at regular intervals, so that no malfunctioning can take place over a long period of time. [15] The FDA`s current position on quality agreements is outlined in the “Contract Manufacturing Arrangements for Drugs: Quality Agreements” guidelines published in 2016. The guidelines expressly state that production activities are the most important element of a quality agreement. It focuses on the seven most important areas that should be addressed in a quality agreement and their specific impact on the quality and control of change. (2) Equipment must be constructed in such a way that surfaces in contact between raw materials, intermediate products or APIs do not alter the quality of APIs beyond official or other specifications.
7. The primary responsibility of the quality unit (s) in a manufacturing and packaging/labelling facility should not be delegated; These responsibilities should be described in writing and include, if necessary, at least two. Specifications for raw materials should be based on process design and the overall control strategy to ensure the quality of the final product. 14. The criteria for acceptability, the nature and scope of the test may depend on the type of API produced, the reaction stage or process performed, and the degree to which the process introduces variability in product quality. Less stringent in-process controls may be appropriate at an early stage of processing, while stricter controls may be appropriate for subsequent processing operations (e.g. B isolation and cleaning steps). 2. The packaging and possession of selected samples is likely to be evaluated in the future to assess the quality of API lots and not for future stability tests. 14. The reintroduction of non-reactive materials into a process and the repetition of a chemical reaction is considered a reprocessing, unless it is an integral part of the established process.
This reprocessing must be preceded by a thorough evaluation to ensure that the quality of the intermediate product or API is not compromised due to the potential formation of by-products and overreacted materials.