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Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages , [ 1 ] cosmetics , [ 2 ] pharmaceutical products , [ 3 ] dietary supplements , [ 4 ] and medical devices . [ 5 ]
The first edition of Juran's Quality Control Handbook was published in 1951. He also developed the "Juran's trilogy", an approach to cross-functional management that is composed of three managerial processes: quality planning, quality control, and quality improvement. These functions all play a vital role when evaluating quality.
A quality control system (QCS) refers to a system used to measure and control the quality of moving sheet processes on-line as in the paper produced by a paper machine. . Generally, a control system is concerned with measurement and control of one or multiple properties in time in a single dimen
Quality inspector in a Volkseigener Betrieb sewing machine parts factory in Dresden, East Germany, 1977. Quality control (QC) is a process by which entities review the quality of all factors involved in production. ISO 9000 defines quality control as "a part of quality management focused on fulfilling quality requirements". [1]
"Good Manufacturing Practices (GMP) relate to quality control and quality assurance enabling companies in the pharmaceutical sector to minimize or eliminate instances of contamination, mix-ups, and errors. This in turn, protects the customer from purchasing a product which is ineffective or even dangerous."
Process analytical technology (PAT) has been defined by the United States Food and Drug Administration (FDA) as a mechanism to design, analyze, and control pharmaceutical manufacturing processes through the measurement of critical process parameters (CPP) which affect the critical quality attributes (CQA).
More specifically, the ISPE's guide The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture describes a set of principles and procedures that help ensure that pharmaceutical products have the required quality. One of the core principles of GAMP is that quality cannot be tested ...
QA/QC is the combination of quality assurance, the process or set of processes used to measure and assure the quality of a product, and quality control, the process of ensuring products and services meet consumer expectations.