manufacturing

100問 • 1年前

問題一覧

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

manufacturing

manufacturing of APIs and exipients

primary manfacturing

manufacture of finished dosage form

seondary

packing, labeling, and repacking of bulk finished products

tertiary

an arrangement whereby a competent company manufactures for another compnay

toll

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

research and development department

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

production department

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

QA department

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

QC department

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

batch

specific identified portion of a batch

lot

for identification and traceability of a single batch

batch number

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

master formula

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

master bach record/ batch manufacturing record

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

SOP

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

overage

color of quarantined products

yellow

color of approved products

green

color of rejected products

red

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

validation

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

packaging

protects content from extraneous solids

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

tight

impprevious to air or any other gas

hermetic

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

highly resistante borosilicate glass

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

treated soda lme glass

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

soda llime glass

orgnic polymers of HMW

plastic

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

thermoplastic

for beverages

1. polyethylene terephthalate

hard thermoset for solid dosage froms

2. high density polyethylene

for blister packs

3. polyvinyl chloride

high temperature resistance

5. polypropylene

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

label

cold

NMT 2-8

freezer

-10 to -20

refrigerator

2-8

cool

8-15

controlled room temperature

20-25

warm

30-40

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

diluent/filler

imparts cohesiveness to powders causing them to form granules

binders

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

antifrictions/flow activators

reduces sticking to punch faces or die walls

anti adherent

blue no.1

brilliant blue FCF

blue no.2

indigoitne

green no.3

fast green FCF

red no.3

erythrosine

red no.40

allura red

yellow no.5

tartrazine

yellow no.6

sunset yellow

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

lakes

salty

cinnamon; orange; cherry; butterscotch

bitter

chocolate; cherry; raspberry; mint

sour

raspberry; lemon; fruity

oily

mint; lmeon; orange

unpleasantly sweet

vanilla; fruity

sucrose

1000x

saccharin

500x

na saccharin

300x

acesulfame K

180-200x

na cyclamate

30x

process in tabblet manufacturing

dispensing-milling-mixing-granulation-tableting-coating

uses air with very high pressure

fluid energy mill

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

batch type mixer

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

continuous mixer

fine granules

pass through sieve no.40

good granules

pass through seive no.20 but not 40

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

asceptc filling area

-most astringent control -class 100

compounding area

-surfaces shoud be continuous -class 10,000

materials support area

Hair should be covered • General protective suit

GRADE D

• 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

GRADE C

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

GRADE B

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

GRADE A

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

FUSION

USES MOLD

COMPRESSIO

MOLDING OF SUPPOSITORY BY USING FINGERS

HAND ROLLING

Both cationic and anionic • Lecithin, Betaine

AMPHOTERIC

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

NONIONIC

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

CATIONIC

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

ANIONIC

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

HIGH MOLECULAR WEIGHT ALCOHOLS

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 powders

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

PRECIPITATION

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

DISPERSION

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

FLOCCULATING AGENTS

Agar, Gelatin, Pectin, Gelatinized starch

OTHERS

Acacia, Tragacanth, Cellulose derivatives

HYDROCOLLOIDS

Veegum, bentonite, kaolin

CLAYS

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

SUSPENDING AGENTS

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

CONSTANT-LEVEL

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

VOLUMETRIC

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

GRAVIMETRIC

Should be carefully monitored and allow constant mixing

Filling and Packaging

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

HOMOGENIZER

Comminution of solids and dispersions of suspension

COLLOID MILL

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

MECHANICAL STIRRER

detachment of the film due to the entrapment of gas

BLISTERING

100

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

CRATERING

gastro

Hannah Angelique Losaria · 100問 · 2年前

gastro