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The goals of a change control procedure usually include minimal disruption to services, reduction in back-out activities, and cost-effective utilization of resources involved in implementing change. According to the Project Management Institute , change control is a "process whereby modifications to documents, deliverables, or baselines ...
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).
An electronic trial master file (eTMF) is a trial master file in electronic (digital content) format.It is a type of content management system for the pharmaceutical industry, providing a formalized means of organizing and storing documents, images, and other digital content for pharmaceutical clinical trials that may be required for compliance with government regulatory agencies.
The book examines how major pharmaceutical companies determine which health care problems are publicised and researched. [1] Outlining the history of the pharmaceutical industry, Law identifies what she says is the failure of a regulatory framework that assumes pharmaceutical companies always produce worthwhile products that society will want. [1]
The Site Master file contains specific and factual GMP information about the production and control of pharmaceutical manufacturing operations carried out at the named site and any closely integrated operations at adjacent and nearby buildings. If only part of a pharmaceutical operation is carried out on the site, the site master file needs to ...
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Pharmaceutical companies routinely use FDA citizen petitions to delay the entry of generic drugs into the United States marketplace. [1] Companies use this to counter the parts of the Drug Price Competition and Patent Term Restoration Act , which make generic drugs more available.