contains the detailed requirements and must be confirmed

implantation test -material in direct contact with tissues

no harm to consumer, no problem in function

digitalis

chloride

regular periodic quality reviews of all registereddrug products to verify consistency of the existing process and to identify product and process improvements

heavy metals

method 1 of bulk density

may cause death o serious adverse health consequences

measure of compressibility

-measure of flowability -maximum angle possible between the surface of the pile of powder nd he horiizontal plane

measure of flowability

sulfate

eye irritation test -opthalmic cntainers

glucagon, atropine

spring

selecting appropriate number from the population

no harm to consumer, product is useless

crude method/ sharp snap (acceptable)

insulin, tobocurarine

-conducts the required test -inspects raw materials, in-process produtcs, fiinished products

-extent to which a product remains stable and within specifications -retains original characterisics nlt 90%

removal of the product from the market because it is either defective of harmful

method 3 of tapped density

heparin, protamin sulfate

retained by #20 seive

cannot b directly measured; color, density

a systematic process for the assessment, control, communication, and review of risks to the quality of the product

-diameter of the circle that will enclose the particles -same as field microscope

oxytocin

undesirable characteristics of a raw material or product which indicates that it failed t conform to the standard

part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate for their intended use

motor driven anvil crushes tablet horizontally; most widely use (eliminates operator vaiability)

PTH

not likely to cause adverse health consequences

air pump/ hydraulic pressure

ma cause temporary/ medically eversible adverse health consequences

measure of dissolution, disintegration, and bioavailablity

systemic injection test -parenteral containers

-audit and monitoring -ensures policies are followed -cooperates with regulatory agencies -prepares SOP

funtional defect

harms consumer, product is useless

defect is visible

period of time during which a product is expected to remain within specification

intracutaneous tets -parenteral containers

cod liver oil chorionic gonadotropin corticotropin vasopressin

pases #40 seive

directly measured by instruments; height, eight, concentration, thickness, volume

defect is not visible

totality features or conformmance to specifications of a product

-designed to increase the rate of chemical degradationby using exagerrated storage conditions -testing period:0,3,6

distance thatwill bisent the particles

pliers (like)

date beyond which product loses stability and after whic it mus not be used

quality is everybody's business

arsenic

-elucidates the intrinsic stability of the drug substance and identify the likely degradation products -ccarried out uner more severe conditions

method 2 of bulk density

passes #20 but not #40 seive

method 1 of tapped density

mmethod 2 of tapped density

iron

method 3 of bulk density

2 tangents seprated by the longest distance

sieve #

suspended motor-driven weight

-conducte under normal conditions -testing period: 0,3,6,9,12,15,18,24,3