Current good manufacturing practice applicability

Applicability of current good manufacturing practice regulations. Definitions. 

In addition to the somewhat empirical and difficult development of NIR applications, thorough documentation must be produced. NIR methods have to comply with the current good manufacturing practice (cGMP) requirements used in the pharmaceutical industry. Various regulatory aspects have to be carefully considered. For example, NIR applications in classification, identification, or quantification require extensive model development and validation, a study of the risk impact of possible errors, a definition of model variables and measurement parameters, and... 

Examples of the U.S. regulations applicable to computer system application in a GMP environment are shown in Table 1. The FDA also publishes compliance policy guides [7] related to pharmaceutical drag products and views the guidance provided on related products (e.g., medical devices [8]) to be current good manufacturing practice that should be considered for comparative GMP applications. 

Most applications require that certifications be included with the submission, either in the administrative section of the application or within reports of specific types of data included in the application. These include field copy certifications, debarment certifications, current good manufacturing practice (cGMP) certifications, current good laboratory practice... 

The dual application of PHS Act requirements (licensing of products and establishments in accordance with 42 ET.S.C. 262, PHS Act section 351) as well as the pharmaceutical current good manufacturing practice (cGMP) regulations derived from the Food, Drug and Cosmetic Act (FD C Act)(21 U.S.C. 374)... 

Drug Application Regulatory Compliance. The approval process for new drug applications includes a review of the manufacturer s compliance with Current Good Manufacturing Practice. This Web page provides resources to help meet compliance. 

The Applicability of Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals is as follows ... 

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