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'''[[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:Knowledge of internal quality control for laboratory tests among laboratory personnel working in a biochemistry department of a tertiary care center: A descriptive cross-sectional study|Knowledge of internal quality control for laboratory tests among laboratory personnel working in a biochemistry department of a tertiary care center: A descriptive cross-sectional study]]"'''


GAMP is largely about automated system validation. In October 2014, Irish tech company Dataworks Ltd. described it as such:
The [[clinical laboratory]] holds a central position in patient care, and as such, ensuring accurate [[laboratory]] test results is a necessity. Internal [[quality control]] (QC) ensures day-to-day laboratory consistency. However, unless practiced, the success of laboratory [[quality management system]]s (QMSs) cannot be achieved. This depends on the efforts and commitment of laboratory personnel for its implementation. Hence, the aim of this study was to find out the knowledge of internal QC for laboratory tests among laboratory personnel working in the Department of Biochemistry, B.P. Koirala Institute of Health Sciences (BPKIHS), a tertiary care center ... ('''[[Journal:Knowledge of internal quality control for laboratory tests among laboratory personnel working in a biochemistry department of a tertiary care center: A descriptive cross-sectional study|Full article...]]''')<br />
 
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"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 />
{{flowlist |
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* [[Journal:Sigma metrics as a valuable tool for effective analytical performance and quality control planning in the clinical laboratory: A retrospective study|Sigma metrics as a valuable tool for effective analytical performance and quality control planning in the clinical laboratory: A retrospective study]]
''Recently featured'': [[End-stage renal disease facility]], [[Genome informatics]], [[Cancer informatics]]
* [[Journal:Why do we need food systems informatics? Introduction to this special collection on smart and connected regional food systems|Why do we need food systems informatics? Introduction to this special collection on smart and connected regional food systems]]
* [[Journal:Data management challenges for artificial intelligence in plant and agricultural research|Data management challenges for artificial intelligence in plant and agricultural research]]
}}

Latest revision as of 18:14, 6 May 2024

Fig1 Mishra JofNepMedAss23 61-258.png

"Knowledge of internal quality control for laboratory tests among laboratory personnel working in a biochemistry department of a tertiary care center: A descriptive cross-sectional study"

The clinical laboratory holds a central position in patient care, and as such, ensuring accurate laboratory test results is a necessity. Internal quality control (QC) ensures day-to-day laboratory consistency. However, unless practiced, the success of laboratory quality management systems (QMSs) cannot be achieved. This depends on the efforts and commitment of laboratory personnel for its implementation. Hence, the aim of this study was to find out the knowledge of internal QC for laboratory tests among laboratory personnel working in the Department of Biochemistry, B.P. Koirala Institute of Health Sciences (BPKIHS), a tertiary care center ... (Full article...)
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