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<div style="float: left; margin: 0.5em 0.9em 0.4em 0em;">[[File:Pharma-production.jpg|200px]]</div>
<div style="float: left; margin: 0.5em 0.9em 0.4em 0em;">[[File:Fig4 Auer CytometryPartA2018 93-7.jpg|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:ChromaWizard: An open-source image analysis software for multicolor fluorescence in situ hybridization analysis|ChromaWizard: An open-source image analysis software for multicolor fluorescence in situ hybridization analysis]]"'''


GAMP is largely about automated system validation. In October 2014, Irish tech company Dataworks Ltd. described it as such:
Multicolor image analysis finds its applications in a broad range of biological studies. Specifically, multiplex [[wikipedia:Fluorescence in situ hybridization|fluorescence ''in situ'' hybridization]] (M‐FISH) for chromosome painting facilitates the analysis of individual chromosomes in complex metaphase spreads and is widely used to detect both numerical and structural aberrations. While this is well established for human and mouse [[wikipedia:Karyotype|karyotypes]], for which species sophisticated software and analysis tools are available, other organisms and species are less well served. Commercially available software is proprietary and not easily adaptable to other karyotypes. Therefore, a publicly available open-source software that combines flexibility and customizable functionalities is needed. Here we present such a tool, called “ChromaWizard,” which is based on popular scientific image analysis libraries (OpenCV, scikit‐image, and NumPy). We demonstrate its functionality on the example of primary Chinese hamster (''Cricetulus griseus'') fibroblasts metaphase spreads and on Chinese hamster ovary cell lines, known for their large number of chromosomal rearrangements. ('''[[Journal:ChromaWizard: An open-source image analysis software for multicolor fluorescence in situ hybridization analysis|Full article...]]''')<br />
 
<blockquote>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.</blockquote>
 
('''[[Good Automated Manufacturing Practice|Full article...]]''')<br />
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''Recently featured'': [[End-stage renal disease facility]], [[Genome informatics]], [[Cancer informatics]]
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Revision as of 22:58, 24 February 2020

Fig4 Auer CytometryPartA2018 93-7.jpg

"ChromaWizard: An open-source image analysis software for multicolor fluorescence in situ hybridization analysis"

Multicolor image analysis finds its applications in a broad range of biological studies. Specifically, multiplex fluorescence in situ hybridization (M‐FISH) for chromosome painting facilitates the analysis of individual chromosomes in complex metaphase spreads and is widely used to detect both numerical and structural aberrations. While this is well established for human and mouse karyotypes, for which species sophisticated software and analysis tools are available, other organisms and species are less well served. Commercially available software is proprietary and not easily adaptable to other karyotypes. Therefore, a publicly available open-source software that combines flexibility and customizable functionalities is needed. Here we present such a tool, called “ChromaWizard,” which is based on popular scientific image analysis libraries (OpenCV, scikit‐image, and NumPy). We demonstrate its functionality on the example of primary Chinese hamster (Cricetulus griseus) fibroblasts metaphase spreads and on Chinese hamster ovary cell lines, known for their large number of chromosomal rearrangements. (Full article...)

Recently featured:

Haves and have nots must find a better way: The case for open scientific hardware
CytoConverter: A web-based tool to convert karyotypes to genomic coordinates
Implementing a novel quality improvement-based approach to data quality monitoring and enhancement in a multipurpose clinical registry