Quality definitions

MVP is a crucial procedure to confirm that the product manufacture is adequate and is generated in a consistent manner with the same quality. Definitions of equipment, rooms, quality of raw materials, and process parameters are necessary to validate the manufacturing process. Maintaining these definitions ensures that the product has the same quality after the process validation. Changes in equipment, raw materials, or process parameters require a manufacturing process revalidation. 

The first step in the product development process is establishing specifications after exploratory research to bring a product to market. Specifications are the quality definition of an article (dosage forms or the related materials for production) upon which acceptance for eventual market distribution is based. The data for establishing pharmaceutical product specifications for both drug substances and dosage forms are defined by identity, purity, strength, and quality, derived from the preformulation study. 

The quality and performance requirements for fuel oils differ widely, although general quality limitations for various fuel grades are used to serve as guides in the manufacture, sale, and purchase of the oils. These quality definitions are often referred to as specifications or classifications, but more precise specifications of quality requirements such as the vapor pressure (ASTM D-323) and metals content (ASTM D-5184, ASTM D-2788, ASTM D-4951, ASTM D-5185, ASTM D-5708, ASTM D-5863, IP 377) may be required for any given application (ASTM D-396). 

With the dissemination of multinuclear multidimensional NMR experiments, the automated NMR resonance assignment became feasible and indispensable, simultaneously.23,35,41,99 Typically, 10-20 individual multidimensional NMR spectra are measured for a large protein. The NMR-derived information quality definitely relies on the resonance assignment. The precious assignment has been based on and assessed by the sequential NOE continuity on the peptide sequence and consistency with the amino acid spin... 

Both commercial and technical needs demand a clear distinction of technical responsibility between the purchaser and the vendor. Commercially, the precise definition of the vendor s responsibility assists the comparison of offers and the manageability of contracts, and is appreciated by vendors who wish to market quality. Definition of responsibility is always fundamental to quality management. 

If you do not have a common quality definition, you invite internally-driven scope creep. For example, assume you as project manager view quality as meeting all requirements, as recommended in the next chapter. You have determined the tasks, deliverables, and schedule needed to meet those requirements have estimated the cost and have entered into a mutually-acceptable agreement with the client, owner, or customer. You are embarking on a potentially successful project—for your organization and for the organization you are serving. 

Olaisen, J. 1990. Information quality factors and the cognitive authority of electronic information. Wormell, I. (Ed.), Information Quality definitions and dimensions, London Taylor Graham. 

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