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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).
The first dedicated department for Pharmacoinformatics was established at the National Institute Of Pharmaceutical Education And Research, S.A.S. Nagar, India in 2003. [2] This has been followed by different universities worldwide including a program by European universities named the European Pharmacoinformatics Initiative (Europin [ 3 ] ).
In the United States, DMFs are submitted to the Food and Drug Administration (FDA). The Main Objective of the DMF is to support regulatory requirements and to prove the quality, safety and efficacy of the medicinal product for obtaining an Investigational New Drug Application (IND), a New Drug Application (NDA),As an Abbreviated New Drug Application (ANDA), another DMF, or an Export Application.
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.
An assay (analysis) is never an isolated process, as it must be accompanied with pre- and post-analytic procedures. Both the communication order (the request to perform an assay plus related information) and the handling of the specimen itself (the collecting, documenting, transporting, and processing done before beginning the assay) are pre-analytic steps.
[[Category:Pharmaceutical company templates]] to the <includeonly> section at the bottom of that page. Otherwise, add <noinclude>[[Category:Pharmaceutical company templates]]</noinclude> to the end of the template code, making sure it starts on the same line as the code's last character.
Pharmaceutical engineering is a branch of engineering focused on discovering, formulating, and manufacturing medication, analytical and quality control processes, and on designing, building, and improving manufacturing sites that produce drugs.
Critical process parameters (CPP) in pharmaceutical manufacturing are key variables affecting the production process.CPPs are attributes that are monitored to detect deviations in standardized production operations and product output quality or changes in critical quality attributes.