QUALITY MANAGEMENT IN THE DRUG INDUSTRY
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QUALITY MANAGEMENT IN THE DRUG INDUSTRY
Quality management is typically
referred to in the larger pharmaceutical
industry as the part of the management function that chooses and puts into practice
the "quality policy," or the overall intention and course of an
organization about quality, as formally expressed and authorized by
top management. The fundamental components of quality management are:
1— an appropriate infrastructure, or
"quality system," encompassing organizational structure, procedures,
processes, and resources;
2— systematic actions required to
ensure sufficient confidence that a Product ( or service) will meet predetermined
standards for quality. Quality assurance refers to the sum of these efforts.
The management tool of quality
assurance is used within a company. Quality control also helps to build
supplier confidence in contractual contexts. Aspects of quality management that
are interrelated include the ideas of quality assurance, GMP, and quality
control.
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