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level: QUALITY FUNCTIONS

Questions and Answers List

level questions: QUALITY FUNCTIONS

Question	Answer
Tests are made not only on the raw materials and packaging components but also on the bulk product during processing and after packaging prior to release to market Selected lots are subjected to shelf life to confirm expiration period	Analysis Functions:
Sample and examine materials while they are being processed Environmental monitoring	Monitor Functions:
Carefully reviewing the batch record for the lot and assuring that all necessary records are present, complete.	Record Review and Release Functions:
SOP must be followed	Audit Function:
Success as an analyst:	1 Manipulative skill acquired by experience 2 Ability to follow directions under supervision of skilled analyst 3 Has fundamental knowledge of theory 4 Practical ability in the application of analytical methods 5 Skill of technique, patience, neatness and accuracy 6 Must not only use common sense in the laboratory but think throughout each step of the procedure
Accuracy and honesty	All quantitative work be performed without even a slight loss of material or gain of extraneous matter At least 2 determinations of any analytical value are required (trials and replicates)
Economy of Time:	1 Keep the working area clean 2 Clean all apparatus immediately after using 3 Label all solutions 4 Keep 2 or more operations going at one time 5 Utilize all time between operations in making calculations and writing up experiments
Must be pure Conform to USP/NF requirement AR grade	Reagents:
Grades of Chemicals:	1 Reagent ACS 2 Guaranteed Reagent (GR)
This designates a high quality chemical for laboratory use. The abbreviation "A.C.S.," means the chemical meets the specifications of the American Chemical Society.	Reagent ACS
Suitable for use in analytical chemistry, products meet or exceed American Chemical Society (ACS) requirements where applicable.	Guaranteed Reagent (GR)
Defines chemicals of good quality where there are no official standards. This grade is usually limited to inorganic chemicals.	Purified
A line of solvents suitable for HISTOLOGY methods and general laboratory applications.	Lab Grade