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It is the company's responsibility to determine the most effective and efficient quality process that both meets business and regulatory needs. [1]: "Decision Makers' Summary", [2] Regulatory agencies have recently begun to look at more fundamental quality metrics of manufacturers than just compliance with basic GMP regulations.
Quality management software centralizes the storage of these documents. Regulatory compliance: To decrease compliance risks, quality management software is used within companies to make sure they comply with ISO, OSHA, FDA, and other industry norms and requirements. The software makes closed-loop corrective and preventive action procedures ...
Weichel (2004) recently found that over twenty warning letters issued by the FDA to pharmaceutical companies specifically cited problems in Computer System Validation between 1997 and 2001. [8] Probably the best known industry guidance available is the GAMP Guide, now in its fifth edition and known as GAMP5 published by ISPE (2008). [9]
Quality management is focused both on product and service quality and the means to achieve it. Quality management, therefore, uses quality assurance and control of processes as well as products to achieve more consistent quality. Quality control is also part of quality management. What a customer wants and is willing to pay for it, determines ...
Good documentation practice (recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained.
IBT, a contract laboratory based in Northbrook, Illinois, conducted research for the United States government and various chemical and pharmaceutical companies, both from the U.S. and abroad, and submitted toxicology data to several federal agencies, covering a wide range of products including drugs, insecticides, herbicides, food additives ...
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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).