manufacturing information

manufacturing information

Information pertaining to the composition, manufacture, stability, and controls used to manufacture a drug substance and drug product. This data is assessed to insure the company can adequately produce and supply consistent batches of a particular drug.
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References in periodicals archive ?
MBD is the practice of having the ONE reference source: a 3D CAD model with semantic PMI (product and manufacturing information) or annotations be the definitive authority model.
This new version promotes the use of work process information through links with related systems, including production measurement systems and component supply management systems, by collecting a wide range of scattered manufacturing information within VPS.
This technology allows for accurate inventory management with real-time connectivity to manufacturing information systems.
This IND application has to contain detailed information about pharmacology and toxicology studies, manufacturing information, protocols for proposed clinical studies and information on the qualifications of the clinical investigators, to assure that research subjects will not be subjected to unreasonable risk.
This starts before a drug is even approved and brought to market, with the FDA's premarket (or preapproval) review of drug applications, including a robust review of manufacturing information, which is a cornerstone of our current regulatory framework."
From its headquarters in Smyrna, TN, about 20 miles southeast of Nashville, PREMIER offers panel fabrication and installation, as well as ICS cyber security and network architecture services in addition to its core business of industrial controls and manufacturing information systems integration.
Members will work with other American Concrete Institute committees to disseminate additive manufacturing information and determine ways the technology can be integrated into the concrete community; collaborate with technical organizations to facilitate information sharing; foster discussion on research needs and challenges preventing additive manufacturing from wide adoption in the concrete construction community; and, develop guidelines to evaluate additive manufacturing materials and technology.
The IND application incorporates information pertaining to completed pharmacology and toxicology studies for efti, along with manufacturing information and proposed clinical protocol for the TACTI-002 trial.
Users, technical or non-technical, can apply CADbro to check product manufacturing information, including data exchanging, interactive 3D CAD viewing, vivid 3D annotation and even advanced analysis capabilities commonly seen in more robust CAD packages.
One of the most significant features of ZW3D 2016 Beta is the newly-developed PMI (Product Manufacturing Information).
SmartFactory[TM] provides an operations management solution for single-use facilities which optimizes plant-wide resource utilization and integrates manufacturing information.
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