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

manufacturing of APIs and exipients

manufacture of finished dosage form

packing, labeling, and repacking of bulk finished products

an arrangement whereby a competent company manufactures for another compnay

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

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

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

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

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

specific identified portion of a batch

for identification and traceability of a single batch

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

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

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

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

color of quarantined products

color of approved products

color of rejected products

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

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

protects content from extraneous solids

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

impprevious to air or any other gas

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

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

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

orgnic polymers of HMW

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

for beverages

hard thermoset for solid dosage froms

for blister packs

high temperature resistance

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

cold

freezer

refrigerator

cool

controlled room temperature

warm

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

imparts cohesiveness to powders causing them to form granules

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

reduces sticking to punch faces or die walls

blue no.1

blue no.2

green no.3

red no.3

red no.40

yellow no.5

yellow no.6

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

salty

bitter

sour

oily

unpleasantly sweet

sucrose

saccharin

na saccharin

acesulfame K

na cyclamate

process in tabblet manufacturing

uses air with very high pressure

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

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

fine granules

good granules

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

-most astringent control -class 100

-surfaces shoud be continuous -class 10,000

Hair should be covered • General protective suit

• 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

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

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

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

USES MOLD

MOLDING OF SUPPOSITORY BY USING FINGERS

Both cationic and anionic • Lecithin, Betaine

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

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

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

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

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

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

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

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

Agar, Gelatin, Pectin, Gelatinized starch

Acacia, Tragacanth, Cellulose derivatives

Veegum, bentonite, kaolin

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

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

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

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

Should be carefully monitored and allow constant mixing

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

Comminution of solids and dispersions of suspension

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

detachment of the film due to the entrapment of gas

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