Outsourcing guidelines

Table A.4, taken from the CCPS Guidelines for Chemical Reactivity Evaluation and Application to Process Design, shows the questions which need to be asked regarding the safety of the proposed reaction, the data required to answer those questions and some selected methods of investigation. The experimental analysis is extremely specialized, and companies should consider outsourcing the tests if they do not have specialists in this area.

This guideline describes methods to help the chemical processing industry apply the CCPS chemical process safety concepts to outsourced manufacturing operations, specifically the tolling vendor-client relationship. In addition to the focus on process safety, information and examples provided in this text foster good practices relative to community and worker health, and environmental responsibility. 

Guidelines for process safety in outsourced manufacturing oerations / Center for Chemical Process Safety, p. cm. 

CCPS 2000. Guidelines for Process Safety in Outsourced Manufacturing Operations. New York American Institute of Chemical Engineers-Center for Chemical Process Safety. 

There are different ways in which an ICS can be implemented, however. The example above is illustrative of an endogenous form of ICS where producers are actively involved in ICS management. At the other end of the spectrum is an exporter-led model, whereby a buyer organises producers and controls the ICS through the implementation of external guidelines to regulate the supply chain and outsourced farmers (Pyburn 2004). Further research is needed to better understand the impacts and dynamics of these different expressions of ICS. 

There is no doubt that companies can save fixed and capital costs and deliver projects faster by the intelligent use of outside agencies. However, there are some guidelines to successful outsourcing. 

Many pharmaceutical companies outsource one or more of the control, manufacturing, and chemistry (CMC) processes, for which numerous regulatory agencies guidelines are available. Reasons for this outsourcing include but are not limited to ... 

Guidelines for Process Safety in Outsourced Manufacturing Operations, G-68 2000. 

Each level of maturity is defined with the help of a detailed list of characteristics. There are organizations that perform process assessment, that is, measure the maturity of a software development organization and provide it with guidelines on how to try to improve to the next level of maturity. An organization s process maturity level gives its customers a basis for realistic expectations of its performance. This is especially important if a company wants to outsource the development of key parts of its software. 

European Commission. Eudralex volume 4 EU guidelines to good manufacturing practice medicinal products for human and veterinary use - Chapter 7 Outsourced activities. 2012, pp 1-4. http //ec. europa.eu/health/files/eudralex/vol-4/vol4-chap7 2012-06 en.pdf Accessed 4 Sept 2014... 

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