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<div style="float: left; margin: 0.5em 0.9em 0.4em 0em;">[[File:Pharma-production.jpg|160px]]</div>
<div style="float: left; margin: 0.5em 0.9em 0.4em 0em;">[[File:Fig2 Berezin PLoSCompBio23 19-12.png|240px]]</div>
'''[[Good Automated Manufacturing Practice]]''' ('''GAMP''') is both a technical subcommittee of the International Society for Pharmaceutical Engineering (ISPE) and a set of guidelines for manufacturers and users of automated systems in the pharmaceutical industry. One of the core principles of GAMP is that quality cannot be tested into a batch of product but must be built into each stage of the manufacturing process. As a result, GAMP covers all aspects of production; from the raw materials, facility and equipment to the training and hygiene of staff.
'''"[[Journal:Ten simple rules for managing laboratory information|Ten simple rules for managing laboratory information]]"'''


GAMP is largely about automated system validation. In October 2014, Irish tech company Dataworks Ltd. described it as such:
[[Information]] is the cornerstone of [[research]], from experimental data/[[metadata]] and computational processes to complex inventories of reagents and equipment. These 10 simple rules discuss best practices for leveraging [[laboratory information management system]]s (LIMS) to transform this large information load into useful scientific findings. The development of [[mathematical model]]s that can predict the properties of biological systems is the holy grail of [[computational biology]]. Such models can be used to test biological hypotheses, guide the development of biomanufactured products, engineer new systems meeting user-defined specifications, and much more ... ('''[[Journal:Ten simple rules for managing laboratory information|Full article...]]''')<br />


"It is a formal process of thorough documentation, testing, and logical process steps that validate clients' required specifications. The process begins with a user requirements specification for the machine, from which a functional requirement and a design specification are created. These documents then form the basis for the traceability matrix and for the formal testing of internal acceptance, factory acceptance, and site acceptance. Categorising software is used to support the approach to validation based on the difficulty and individuality of the computerised system." ('''[[Good Automated Manufacturing Practice|Full article...]]''')<br />
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Latest revision as of 18:03, 10 June 2024

Fig2 Berezin PLoSCompBio23 19-12.png

"Ten simple rules for managing laboratory information"

Information is the cornerstone of research, from experimental data/metadata and computational processes to complex inventories of reagents and equipment. These 10 simple rules discuss best practices for leveraging laboratory information management systems (LIMS) to transform this large information load into useful scientific findings. The development of mathematical models that can predict the properties of biological systems is the holy grail of computational biology. Such models can be used to test biological hypotheses, guide the development of biomanufactured products, engineer new systems meeting user-defined specifications, and much more ... (Full article...)

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