Outsourced manufacturing, defined

Facilities and Equipment The technical experts who have an understanding of pharmaceutical science, risk factors, and manufacturing processes related to the product are responsible for defining specific facility and equipment requirements. The equipment must be qualified, calibrated, cleaned, and maintained to prevent contamination and product mix-ups. It is important to remember that the GMPs place as much emphasis on process equipment as on testing equipment while most quality systems focus only on testing equipment. Control Outsourced Operations Quality systems call for contracts with outside suppliers that clearly describe the materials or service, quality specification responsibilities, and communication mechanisms. 

These are also the easiest supply chains to outsource to a third party. However, not all industries have viewed this opportunity the same. For high-tech leaders that defined the best use of their manufacturing capacity to be focused on the launch of new products (with less of a focus on internal asset utilization), they quickly outsourced products in this quadrant to third-party manufacturers. For consumer products leaders with a myopic focus on internal asset utilization, they keep the production of products in quadrant II for internal production, and outsource products in quadrants I and IV. As a result, consumer products companies reduce manufacturing costs but increase total costs of the supply chain. 

In a third step, a sensitivity analysis is carried out. Here, the defined key modules are assessed with regard to their costs and manufacturability. Furthermore, other important factors as, for example, resource availability, technological requirements and the potential for outsourcing parts of the manufacturing process are included in the analysis. Moreover, the modules suitability for assembly is the subject of the sensitivity analysis. If the results of the analysis indicate any insufficiency, the module development process has to be repeated. 

Prior to 1995, Pfizer was not running nitration reactions in-house due to potential thermal hazard issues. In 1995, a safety group was established with the mandate to define acceptable operating conditions for potentially dangerous reactions, which we used to outsource exclusively. After die appropriate testing was completed, the nitration in Scheme 12 was conqileted in two 5 kg runs in-house. This reduced the timing for the final bulk delivery by nearly two months compared to sending this reaction to an outside toll manufacturer. 

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