Pharmaceutical manufacture definition

This previous definition had been broadened after the FDA s issue of the PAT guidance document to encompass aU factors influencing the quality and efficiency of a chemical or pharmaceutical manufacturing process. Driven by developments in Six-Sigma and operational excellence programs an extended definition included such items as ... 

A pharmaceutical manufacturing system design requires significant level of innovation. The broadest definition of innovation is the act of introducing something new to a society or community, whether a product or process. This is often confused with invention, which focuses more on specific objects. Within pharmaceuticals innovation can therefore include new business structures within the company,... 

Project and quality planning by each company is important for multigroup projects, as it enables all those involved in the project—pharmaceutical manufacturer, vendor, or third party—to access a formal definition of project standards, schedule, organization, and contracted responsibilities and monitor interaction at all levels. If elements of the contracted work and supply are to be subcontracted the plan must detail how this work is to be controlled and reported. The supplier project and quality plan must be a contractual document agreed upon by the purchaser and supplier and needs to ensure that ... 

From this point in the design and development it is normally the supplier s contracted responsibility to lead the review activities and to provide all documentation and information necessary to undertake each review. To best ensure that the requirements detailed during the definition phase are fully covered by system design and development, the key review sessions should have appropriate representation from the groups primarily involved with the system application and operation and should verify adherence to the supplier s project and quality plan. This involvement will afford the pharmaceutical manufacturer a better understanding of the documentation that details how the supplier is meet-... 

The definition of pharmaceutical manufacturing processes is however not given. 

A disperse system is defined as a heterogenous, two-phase system in which the internal (dispersed, discontinuous) phase is distributed or dispersed within the continuous (external) phase or vehicle. Various pharmaceutical systems are included in this definition, the internal and external phases being gases, liquids, or solids. Disperse systems are also important in other fields of application, e.g., processing and manufacturing of household and industrial products such as cosmetics, foods, and paints. 

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