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Pharmaceutical manufacturing is the process of industrial-scale synthesis of pharmaceutical drugs as part of the pharmaceutical industry. The process of drug manufacturing can be broken down into a series of unit operations, such as milling, granulation, coating, tablet pressing, and others.
Most contract manufacturing agreements will include some, or all of, the following elements:Non-disclosure Agreements (NDA)Licensing Agreements.Purchase Orders.Quality Standards.Supply Chain Agreements.Essential Processes.Termination Clauses.
A pharma contract manufacturing company provides an array of services to drug companies which may include: Drug development. Drug manufacturing and commercial production. Documentation of compliance with FDA regulatory requirements.
10 Areas to Consider When Selecting a Contract ManufacturerCapabilities.Experience and expertise.Quality of products or components.Confidentiality.Quality management systems and certifications.Communication and documentation style.Longevity and stability.Total costs.More items...?
Contract manufacturing involves hiring a third-party company to create, manufacture, and/or assemble your product. Some contract manufacturers get involved in the process very early, helping you design a product for manufacturing and building prototypes to test before the first manufacturing run begins.