totality features or conformmance to specifications of a product

quality is everybody's business

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

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

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

selecting appropriate number from the population

contains the detailed requirements and must be confirmed

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

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

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

defect is visible

defect is not visible

funtional defect

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

cannot b directly measured; color, density

no harm to consumer, no problem in function

no harm to consumer, product is useless

harms consumer, product is useless

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

may cause death o serious adverse health consequences

ma cause temporary/ medically eversible adverse health consequences

not likely to cause adverse health consequences

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

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

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

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

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

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

glucagon, atropine

oxytocin

PTH

digitalis

cod liver oil chorionic gonadotropin corticotropin vasopressin

heparin, protamin sulfate

insulin, tobocurarine

systemic injection test -parenteral containers

intracutaneous tets -parenteral containers

eye irritation test -opthalmic cntainers

implantation test -material in direct contact with tissues

heavy metals

arsenic

iron

chloride

sulfate

2 tangents seprated by the longest distance

distance thatwill bisent the particles

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

sieve #

retained by #20 seive

passes #20 but not #40 seive

pases #40 seive

method 1 of bulk density

method 2 of bulk density

method 3 of bulk density

method 1 of tapped density

mmethod 2 of tapped density

method 3 of tapped density

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

measure of compressibility

measure of flowability

measure of dissolution, disintegration, and bioavailablity

crude method/ sharp snap (acceptable)

spring

air pump/ hydraulic pressure

pliers (like)

suspended motor-driven weight

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