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This COBie MVD, produced under contract to the Construction Engineering Research Lab, was created by the buildingSMART international Model View Definition support group, and was based on IFC 4. [9] The main standard contains the project's Information Delivery Manual and Model View Definition as well as business case and implementation resources.
The database serves as a quick reference for checking the good manufacturing practice (GMP) of a potential contract manufacturer. One can search by the “company name, location, or certificate number and find details on the types of products or activities that the company conducts and the date of the most recent GMP inspection.” [ 3 ]
Good manufacturing practice (GMP) Best practice; American National Standards Institute (ANSI) Institute of Electrical and Electronics Engineers (IEEE) European Medicines Agency (EMEA) Food and Drug Administration (FDA) Ministry of Health, Labour and Welfare (Japan) Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation ...
Uniform Office Format (UOF; Chinese 标文通, literally "standard text general" [1]), sometimes known as Unified Office Format, is an open standard for office applications developed in China. [2] It includes word processing, presentation, and spreadsheet modules, and is made up of GUI , API , and format specifications.
Besides differences in the schema, there are several other differences between the earlier Office XML schema formats and Office Open XML. Whereas the data in Office Open XML documents is stored in multiple parts and compressed in a ZIP file conforming to the Open Packaging Conventions, Microsoft Office XML formats are stored as plain single monolithic XML files (making them quite large ...
GAMP itself was founded in 1991 in the United Kingdom to deal with the evolving U.S. Food and Drug Administration expectations for good manufacturing practice (GMP) compliance of manufacturing and related systems. [4] GAMP published its first guidance in 1994.
A guaranteed maximum price (also known as GMP, not-to-exceed price, NTE, or NTX) contract is a cost-type contract (also known as an open-book contract) such that the contractor is compensated for actual costs incurred plus a fixed fee, which is limited to a maximum price. The contractor is responsible for cost overruns greater than the ...
In this case, failure to adhere to proper CAPA handling is considered a violation of US Federal regulations on good manufacturing practices. As a consequence, a medicine or medical device can be termed as adulterated or substandard if the company has failed to investigate, record and analyze the root cause of a non-conformance, and failed to ...