prelim Flashcards
if the sample is a drug
ASSAY
Involves the identification of the following:
• composition determination
• ascertainment of impurities present in a given sample
• Answers the question: WHAT IS PRESENT IN A GIVEN SAMPLE?
QUALITATIVE
determination of the proportion of components in a given sample
Answers: HOW MUCH IS
PRESENT IN THE SAMPLE?
QUANTITATIVE
Totality of characteristics or features of a product that bears on its capacity to satisfy stated or implied needs
QUALITY
• sum total of the organized arrangements made with the object of ensuring that products will be consistently of the quality required by their intended use
• based on process approach
• done before starting a project
• proactive or preventive process to avoid defects
QUALITY ASSURANCE
part of GMP concerned with sampling, specifications, testina organization • product based approach
• checks deliverables if it satisfy the quality requirements and specifications of customers
• begins once the product is manufactured
QUALITY CONTROL
statement of ingredients (% age, wt)
FORMULA
purity of ingredient
RAW MATERIAL SPECIFICATION
step by step method; covers instructions in the production
SOP
total amount of class or group of active plant principles in a given sample
PROXIMATE
involves crude drugs and natural products derived from them
eg. Water content determination,
Ash content, Acid
MISCELLANEOUS/SPECIFIC METHOD
the determination of the volume of a solution of known concentration required to react with a given amount of the substance to be analyzed
VOLUMETRIC ANALYSIS
based on some specific physical or chemical property/ properties of the substance being analyzed
• involve instrumental techniques such as chromatography,
spectrophotometry, refractometry, polarimetry
PHYSICOCHEMICAL METHOD
the separation by extraction, precipitation, or other means of the constituent to be determined either in the natural state or in the form of a definite compound the composition of which is known to the analyst, and the weighing of the resulting product
GRAVIMETRIC ANALYSIS
those which require a distinct type of technique such as alkaloidal assaying
SPECIAL METHOD
done simultaneously
REPLICATES
done at different time
TRIALS
high quality chemical for laboratory use (American
Chemical Society)
REAGENT ACS
suitable for use in analytical chemistry, products meet or exceed ACS requirement
GUARANTEED REAGENT
more or less similar to ACS
ANALYTICAL REAGENT
for titration
PRIMARY STANDARD
chemicals of good quality where there are no official standards; usually limited to inorganic chemicals.
PURIFIED
a line of solvents suitable for histology methods and general laboratory application
LINE
chemicals manufactured under cGMP and meet requirements of USP
USP GRADE
suitable for general industrial use
TECHNICAL GRADE
undesirable characteristics of a product
DEFECTS
cannot be measured by any instrument (ex: odor, cleanliness)
ATTRIBUTE DEFECT
measured by instruments (ex: weight, thickness
VARIABLE DEFECT
endanger life or property, may render product nonfunctional (ex: disintegration time)
CRITICAL DEFECT
may render product useless (ex: cracked bottle)
MAJOR DEFECT
does not endanger life nor affect function (ex: label)
MINOR DEFECT
visible (foreign particulate)
OCULAR DEFECT
not seen (subpotent)
INTERNAL DEFECT
a defect in function (ex: suppository that does not melt in body temperature)
PERFORMANCE DEFECT
examine raw materials received
• conduct physical test for packaging materials
MATERIALS INSPECTION SECTION
performs physical and chemical analysis
ANALYTICAL LABORATORY
performs microbiological, pharmacological, strerility and toxicity tests
• conducts environmental monitoring
BIOLOGICAL TESTING LABORATORY
research development
• validate procedures
• develop new assays
• develop and improve final product
ANALYTICAL/RESEARCH DEVELOPMENT
Maintain records
• Investigate complaints
• Maintain and develop SOP
QUALITY COORDINATION OFFICE
• to assure acceptability of product
• all materials are within specifications
ANALYSIS FUNCTION
• in process testing
• any deviation must be reported
• environmental monitoring
MONITORING FUNCTION
all records during course of producing quality controlled product
BATCH RECORD
secure a representative samples; sampled from different parts
SAMPLING
Finite number of objects selected from a given population
SAMPLE
direct contact with the product
Ex: Caps, capsules, bottles
PRIMARY PACKAGING COMPONENTS
Components - do not come in direct contact
Ex: Labels, inserts and cartons
SECONDARY PACKAGING
vitamins, flavors
6 months
dyes
12 months
