問題一覧
1
standardise the requirements for medicines regulaton throughout the world.
international conference of harmonisation
2
three types of systematic error
environmental observational instrumental
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-these can arise due to random and unpredictable fuctuatons in experimental conditons
random error
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deined as the reproducibility of results and measurements
precision
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a branch of practcal chemistry that involves a series of process for identicaton, determinaton, quanticaton , and puriicaton of a substance
pharmaceutical analysis
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the combinaton of atributes or characteristcs of a product which, when compared to a standard, serves as a basis for measuring the uniformity of the product
quality
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when was international organization of standardization founded
1946-1947
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performed to establish composition of natural/synthetc susbtances.
qualitative analysis
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type of error that, although sometmes unsuspected, may be avoided or determined and corrected once they are uncovered
determinate error
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-Overall organizatonal body designed assign to assure product quality
quality assurance
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To determine accuracy and completeness of all records generated during the course of producton prior to the release of each lot of inished product to the market.
record review and release function
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-takes into account human oversight and other mistakes hile reading, recording, and readings
gross error
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provides an exact descripton of how the analysis is carried out.
analytical procedure
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-a process inside an organizaton ith the aim to improve its performance
benchmarking
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-Conducts testng on the ra materials and packaging components and bulk products
analysis function
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-Quality assessment ith an atached judgement that the evaluated unit is good enough to have the right to exist in a partcular system
accreditation
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what are the two types of chemical analysis
quantitative and qualitative analysis
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5 quality control divisions
material inspection section , analytical laboratory , biological testing laboratory , quality coordination office , specification and analytical development
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A voluntary, non-treaty federaton of standards setting bodies of some 130 countries.
international organization of standardization
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refers to how clole the value is to the actual or true value.
accuracy
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Techniques are mainly used to quantify any compound or substance in the sample
quantitative analysis
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Is a tool, hich gives the assurance that a product conforms to standards andspeciicatons through the system of inspection analysis and action
quality control
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COMMON DIVISIONS IN A MANUFACTURING FIRM
finance, production, quality assurance, marketing
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type of error caused by uncontrollable fuctuatons in variables that afect experimental results.
indeterminate error
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when and where was ICH initiated
brussels at 1990
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A management approach for an organizaton, centered on quality based on the partcipaton of all its members and aiming at long term success through customer satsfacton
total quality management
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To train employees to comply ith the SOP’s and to understand hy and ho these SOPs are to be followed
audit function
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Refers to the measure or step that is used to prevent or eliminate drugs risks/hazards to make it safe and efectve
control
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deined as a deviaton from the absolute value or from the true value
error
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To control the microbial and partculate mater content of environmental air in areas here pharmaceutcals such as parenterals are processed.
monitor function
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Established at the concepton of a ne product, during producton of the batch, and during distributon of the commercial package
quality control system
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individuals ho had experience and ho are familiar ith the physical characteristcs of the materials they sample and are ell versed in sampling techniques.
inspector