問題一覧
1
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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standardise the requirements for medicines regulaton throughout the world.
international conference of harmonisation
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when and where was ICH initiated
brussels at 1990
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what are the two types of chemical analysis
quantitative and qualitative analysis
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performed to establish composition of natural/synthetc susbtances.
qualitative analysis
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Techniques are mainly used to quantify any compound or substance in the sample
quantitative analysis
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deined as a deviaton from the absolute value or from the true value
error
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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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type of error caused by uncontrollable fuctuatons in variables that afect experimental results.
indeterminate error
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-takes into account human oversight and other mistakes hile reading, recording, and readings
gross error
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-these can arise due to random and unpredictable fuctuatons in experimental conditons
random error
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three types of systematic error
environmental observational instrumental
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deined as the reproducibility of results and measurements
precision
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refers to how clole the value is to the actual or true value.
accuracy
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provides an exact descripton of how the analysis is carried out.
analytical procedure
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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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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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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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-Overall organizatonal body designed assign to assure product quality
quality assurance
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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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-a process inside an organizaton ith the aim to improve its performance
benchmarking
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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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-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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A voluntary, non-treaty federaton of standards setting bodies of some 130 countries.
international organization of standardization
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when was international organization of standardization founded
1946-1947
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COMMON DIVISIONS IN A MANUFACTURING FIRM
finance, production, quality assurance, marketing
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-Conducts testng on the ra materials and packaging components and bulk products
analysis function
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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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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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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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5 quality control divisions
material inspection section , analytical laboratory , biological testing laboratory , quality coordination office , specification and analytical development
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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