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Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages , [ 1 ] cosmetics , [ 2 ] pharmaceutical products , [ 3 ] dietary supplements , [ 4 ] and medical devices . [ 5 ]
ISPE has published a series of good practice guides for the industry on several topics involved in drug manufacturing. The most well-known is The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture.
By the release of version 3 in March 1987, a million users were claimed. [4] New versions were published into the early 1990s, after which Microsoft Excel dominated the spreadsheet market. In 1993, the Ministry of Railway of Russia signed an agreement with CA Technologies after a Russian employee illegally used SuperCalc for government purposes.
The desired results are established in terms of specifications for outcome of the process. Qualification of systems and equipment is therefore a part of the process of validation. Validation is a requirement of food, drug and pharmaceutical regulating agencies such as the US FDA and their good manufacturing practices guidelines. Since a wide ...
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.
The Document Theme defines the colors, fonts and graphic effects for a document. Almost everything that can be inserted into a document is automatically styled to match the overall document theme creating a consistent document design. The new Office Theme file format (.THMX) is shared between Word, Excel, PowerPoint and Outlook email messages.
The Microsoft xls file format which is the default file format used in versions prior to 2007 had a capacity limit of 65,536 rows by 256 columns (2 16 and 2 8 respectively). [71] This presents a problem for people using larger datasets, and can result in data loss.
The file starts with a header containing a magic number (as a readable string) and the version of the format, for example %PDF-1.7. The format is a subset of a COS ("Carousel" Object Structure) format. [23] A COS tree file consists primarily of objects, of which there are nine types: [16] Boolean values, representing true or false; Real numbers ...