Scope of Processes

Table 4 Specific Responsibilities of Each Organizational Structure within the Scope of Process Validation... 

Communication Contexts The scope of processes or processors that receive a given set of messages. 

There is a vast scope of process integration in the pharmaceutical and fine-chemical industries. 

Interaction Matrix—The interaction matrix is a tool for understanding potential reactions between materials that is sometimes used in petro-chemical or chemical process reviews. A typical matrix will list all the chemical raw materials, catalysts, solvents, potential contaminants, materials of construction, process utilities, human factors, and any other pertinent factors on the axis. Process utilities are generally listed on only one axis, as utility interactions are outside the scope of process development (these are usually addressed later on during process HAZOPs). Interaction of three or more components is generally handled by listing combinations as separate entries. Each interaction is then considered and the answer documented. Documentation should include notes on the anticipated interactions, specific references, and previous incidents. An interaction matrix is best prepared by a chemist or chemical engineer, then circulated to others to fill in open blocks, make modifications, and review. There may be interactions with unknown consequences that require further research and/or experimentation. 

The first stage and initiation of the cycle is an idea to start a business and definition of preliminary strategic assumptions including branch, range and scope of processes to be realized. 

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