QUALITY MANAGEMENT IN THE DRUG INDUSTRY

  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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