Acacia, Tragacanth, Cellulose derivatives

-surfaces shoud be continuous -class 10,000

step-by-step instruction for performing an operational task or activity

type II glass surface is treated with SO2; dealkalized; for buffered acidic non aqueous solutions

specific quantity of products itended to have uniform character an dquality produced during a single manufacturing process

process in tabblet manufacturing

na cyclamate

saccharin

cratter appear exposing the tabllet surface due to coating solution penetratiing parts of the surface where it is more porous

Finely divided solid drug is reacted with another substance, Ex.: Milk of Magnesia

fine granules

ensures that batches were properly made and qc tests were perormed; actual yield

for blister packs

an economic way of protecting, preparing, identifing, an contaning prducts

detachment of the film due to the entrapment of gas

blue no.1

freezer

salty

large scale production of drug products' preparation, processing, packaging, labeling, repacking, chamging wrapper, label or container of any drug products

Heart of Production area • HEPA: 99.97% efficiency against 0.3 mcm or larger • QC test: DOP, Bubble point test, HC Emery 3004

red no.3

contains formulation, manufacturing procedures, specifications, QA requirements, and labeling of finihsed products

water insoluble dies that had been absorbed on hydrous oxide usually alumina, used as dry powders

formulates new products; reformulates new products, does chemical, pharmaceutical and physiological research

Local zone for high-risk operations • Filling zone, stopper, aseptic connections • Laminar air flow workstation with a HEPA • Compounding Area

Form o/w emulsions when the insoluble material is added to the aq. Phase if there is a greater volume of the aqueous phase than of the oleaginous phase • Ex.: Bentonite magma, veegum

protects content from extraneous solids

display of written, printed, or graphic matter on immediate conatiner

Both cationic and anionic • Lecithin, Betaine

reduces sticking to punch faces or die walls

documented evidence that a system does what it is supposed to do

impprevious to air or any other gas

for identification and traceability of a single batch

Compresses liquid with high pressure by a strong spring mechanism for emulsification

Viscosity-increasing agents used to reduce sedimentation rate of particles in a vehicle

hard thermoset for solid dosage froms

bitter

Background environment ofGradeA • Both Grade A and B should observe: o Headgear totally enclose hair o Face mask o Tucked trouser pants

uses the container as the means for controlling the fill. Adjusted by height.

test compliance of raw materials, packaging materials, and fnished products; conducts sampling of materials to be tested; performs IPQC and environmental testing

manufacture of finished dosage form

Veegum, bentonite, kaolin

color of approved products

Agar, Gelatin, Pectin, Gelatinized starch

manufactures products according to schedule; warehousing (inventory control) and storage

Comminution of solids and dispersions of suspension

high temperature resistance

Finely divided solid drug is wetted first before dispersion in the liquid vehicle

warm

refrigerator

• Hair should be covered • Single or two-piece suit gathered at the wrist and with high neck and appropriate shoes or overshoes should be worn • should shed virtually no fibers or particulate matter

imparts cohesiveness to powders causing them to form granules

all ingredients are loaded together , mixed and discharged as a single batch

red no.40

type I glass: with boric acid; high resistance; for buffered and non buffered aqueous parenteral solution

packing, labeling, and repacking of bulk finished products

acesulfame K

yellow no.5

Not affected by pH • Sorbitan esters/SPANS, Polysorbates/TWEENS

MOLDING OF SUPPOSITORY BY USING FINGERS

Hair should be covered • General protective suit

Thickening agents and stabilizers for o/w emulsions of certain topical preparations • Ex.: Stearyl/cetyl ROH, glyceryl monostearate (O/W); Cholesterol derivatives (W/O)

Negative, effective at basic pH • SLS, soap, sarcosinates

cool

color of rejected products

sucrose

controlled room temperature

type of plastic that is soft when heated and hard when cooled; flexible and squeezable

hydrophobic powders added prior to compression to reduce friction and improve flow properties

Decreases zeta potential of the suspended charged particles that cause aggregation.

specific identified portion of a batch

USES MOLD

green no.3

unpleasantly sweet

na saccharin

sour

uses air with very high pressure

an arrangement whereby a competent company manufactures for another compnay

protects content from extraneous solids, liqids, and vapors; protects from delinquescence, effflorescence, evaporation

Should be carefully monitored and allow constant mixing

-most astringent control -class 100

Positive, effective at acidic pH • Benzalkonium Cl, Cetylpyridinium Cl

for high volume products; materials travel from charging port to dischharge nozzle

blue no.2

Weighing according to weight • For large containers, highly viscous liquids, mobile and frothy solutions

yellow no.6

innert substance added to increase tablet size which is practical for compression

addition of an API in an unstable preparation to compensate for loss during manufacture

good granules

assures that all operations meet required standards for safety and efficacy; ensures compliance to cGMP; prepares SOPs

color of quarantined products

Positive displacement of piston action or by the pumping of a liquid at a constant pressure and gives constant volume

oily

Components are combined by melting together (70-75C) and cooled with constant stirring until congealed • Equipment: Stem-jacketed Kettle

Mixers with various impellers mounted on shafts, PROBLEM: Vortex formation

orgnic polymers of HMW

for beverages

type III glass low resistance; for reconstituted dry solids and non aqueous liquids

cold

manufacturing of APIs and exipients