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- W2472297795 abstract "70 Commissioning, as a validation-related activity, is a recent practice in the Pharmaceutical industry. As with other initiatives related to facility and system qualification, it too has developed into an industry of its own. The term was not an invention of this industry, it is a military term. More exactly, it is a Navy term. It was, and is, a procedure that is performed on new construction to ensure functionality. (Figure 1.) Commissioning as a documented activity, was introduced to the pharmaceutical industry in 1994 in an article that was published in the Pharmaceutical Engineering . It was presented as a means of organizing the complicated and expensive process of licensing a pharmaceutical facility. This process was the verification, qualification, and validation of a pharmaceutical facility. The focus of the article is to demonstrate that a properly orchestrated construction and testing effort could lead to a more streamlined and cost-effective project. This conclusion was true at the time of the article publication date in 1994, and is still true today. There are those in the pharmaceutical industry who decided that by taking the methodology of commissioning and incorporating it with the concept of Good Engineering Practice (GEP), it was possible to reduce the burden of validation. The merits of validation are well-known and publicized. Its purpose is to offer rationalization and verification of a manufacturing process. To many, validation is a costly and time consuming undertaking. It is viewed as a paper chase, and a government sponsored “pass-go” initiative. Commissioning offered an avenue to reduce duplication of testing, as well as eliminate the activity of process validation from specified systems and equipment. The International Society of Pharmaceutical Engineers (ISPE) took up the lead by publicizing the methodology, which stressed the commissioning approach. Commissioning in conjunction with the concept of GEP would be used to justify certain tests and systems standing on their own merit. These systems would have no need of qualification as presented by the validation approach." @default.
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- W2472297795 date "2003-01-01" @default.
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- W2472297795 title "Commissioning issues and considerations" @default.
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