Manuf (PACOP 💚💜)

Feret's diameter, df

Particle size is a basic property of a powder. Which of the following expression of diameterthat describes the distance between pairs of parallel tangents to the projected outline of the particle in some fixed direction?

Martin's diameter, dm

Expression of diameter that represents the particle size of a powder having the length of a chord equally dividing the projected outline of the particle in some fixed direction

poor

the % compressibility of a powder is 23-35%, the powder flowability is ___.

major defect

classification of defect which may affect the function of the object and therefore, may render the product useless (eg. presence of a crack in a bottle)

internal defect

classification of defect which is not seen although present

Distillation

Ion-exchange treatment

Reverse osmosis

Purified water, USP is water obtained by

distillation

Brandy and whisky are example of spirits that are prepared by:

homogenizers

equipment used in the preparation of emulsion wherein the dispersion of two liquids by forcing the mixture through a small inlet orifice at high pressures:

slow sedimentation rate

basic desirable property of a suspension wherein the dispersed phase should settle slowly without forming a hard cake

impact strength

Mechanical properties of plastic packaging material that has the ability to withstand shock- loading, where a specimen receives a blow from a swinging pendulum as an example:

2% camphor and 3% castor oil

added to make a flexible collodion?

pack size

refers to the quantity of dosage form in the final packaging (excluding the shipping carton) of a drug product bearing the required labeling information:

03 Jun 2007

June 2007

correct labeling format for product's manufacturing and expiration date?

investigational product

pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial

Capital letters against a red background or printed in red font

For products that are intended for external use the statement "For external use only shall appear on all labeling materials. Which of the following is the correct format?

prodrug

synthetic derivatives (eg, esters and amides) of drug molecules that may have intrinsic pharmacologic activity but usually must undergo some transformation in vivo to liberate the active drug molecule

capping

partial or complete separation of the top or bottom crowns of a tablet from the main body

mottling

unequal distribution of color on a tablet, with light or dark areas standing out in an otherwise uniform surface

picking

term used to describe the surface material from a tablet that is sticking to and being removed from the tablet's surface by a punch

slugs

When the initial blend of powders is forced into the dies of a large-capacity tablet press and is compacted by means of a flat-faced punches, the compacted masses are called

Lead to browning and discoloration with certain drugs

Maillard reaction is

97%, 3%

Dipac is a sucrose-based diluent containing sucrose plus modified dextrins

implantation tablets

purpose of this tablet is to provide prolonged drug effects, ranging from one month to a year

Sodium bicarbonate

Citric acid

Tartaric acid

Components of an effervescent tablets

inserts

vaginal tablets are also called

Syruping

Polishing

Subcoating

Sealing

basic sugar coating process involves the following steps

syruping

step in coating process that cover and fill in the imperfections in the tablet caused by subcoating step:

Sticking and Picking

film defect that caused by over wetting or excessive film tackiness causes tablets to stick to each other or to the coating pan giving a

roughness

film defect that has a gritty surface often observed when the coating is applied by a spray

Orange-Peel Effects

film defect that resulted from inadequate speading of the coating solution before drying causes a bumpy effect on the coating

bridging and filling

During drying, this film defect may shrink and pull away from the sharp corners of an intagliation or bisect and results in a thick film that fills and narrows the monogram or bisect that is caused by applying too much solution

blistering

When coated tablets require further drying in ovens, too rapid evaporation of the solvent from the core and the effect of high temperature on the strength, elasticity and adhesion of the film may result this defect

hazing/dull film

film defect is sometimes called bloom because it can occur when too high a processing temperature is used for a particular formulation:

color variation

film defect problem can be caused by processing conditions or the formulation

cracking

film defect occurs if internal stresses inthe film exceed the tensile strength of the film

disintegrants

component is added to most tablet formulation to facilitate the breakup of the tablet when it comes in contact with water in the GIT

diluent

tablet component that make up the major portion of the tablet

0.03%

maximum of ___ used of soluble dye isthe “rule of the thumb” in concentration of colorants to be

chipping

tablet processing problem that resulted from the removal of edges of tablets

pfizer hardness tester

type of mechanical hardness tester that operates with the same principle as a pliers

85-115%

USP limit for content uniformity

Polyethylene glycol

Component of film coating solution that provides water permeability

surfactant

Polyoxyethylene sorbitan is an example of___, that enhance spreadability of the film during application:

Cellulose acetate phthalate

function of this component of coating solution is to form a smooth thin film under ordinary coating process

Plasticizer

Castor oil is an example of ___ that produce flexibility and elasticity of the tablet coating

colorants

These are added to film coating to make the tablet elegant and distinctive

disintegration time

According to USP it is a state in which any residue of the tablet, except the fragments of insoluble coating, remains on the screen is a soft mass having no firm core:

Constant heat

Basket

A motor with lever

Disintegration apparatus:

sodium bisulfite

Antioxidant of choice for parenterals

magnesium stearate

Most widely used lubricant in pharmaceutical products

pentanol

Medium chain alcohol that serves as cosurfactant in the preparation of microemulsions

Effervescent tablets

Type of compressed tablet that produces CO2 upon the reaction of its components with water

die

part of the tablet press machine that determines the size and shape of the tablet

cams

part of the tablet press machine that guides the movement of the machine

glidant

Substance that improves the flow characteristics of a powder mixture

cream

condition of emulsion wherein the dispersed phase floats out and concentrates on top:

suspending agents

Substance added in a suspension to overcome agglomeration of the dispersed particles and to increase the viscosity of the medium so that the particles settle down slowly is called:

delayed release tablet

Type of solid dosage form where the drug substance is not released until a physical event has occurred

30°C and 65%

What is the temperature and RH set-ups for the revised Zone 4A (Hot and Humid) in Long Term Stability test?

6 months

Minimum duration under ICH Accelerated Testing Condition

NMT 15% of the labelled potency

overage limits for dry solid dosage forms such as tablets and capsules

Plasticizer

PEG and Glycerin are ___ that are employed for the coating solutions to improve the quality of the film onto tablet surface

13-16%

How much moisture should empty hard gelatin capsules contain, in order to prevent brittleness and shrinkage?

Zone IV A

What zone of global assessment of stability Philippines is classified to?

non ionic

span and tween

real time stability test

involves the normal conditions of temperature and moisture, which the product will typically encounter in the actual market place of the product

tartrazine

dye component in FD&C Yellow No. 5 which causes allergic type reactions in many people

gasket

Valve assembly component that prevents the leakage of formulation when the valve is closed

stem

Valve assembly component that supports the actuator and delivers the formulation in the proper form to the chamber of the actuator

valve

Component of an aerosol package capable of delivering the content in the desired

Afrezza (Sanofi)

First insulin inhaler approved in the market

clean room

area/room with a defined environmental control of particulate and microbial combination constructed to minimize the introduction, generation and retention of contaminants within the area.

mannitol

The preferred diluents for chewable tablet since it has a pleasant ding sensation due to the negative heat of solution

tablet hardness

Quality standard and compendia requirement test used to measure the degree of force to break a tablet

air lock room

Access of personnel to aseptic corridors, dispensing and compounding rooms is only through

aspartame

Sweetening agent contraindicated to patient with phenylketonuria

annatto

reddish-orange natural food dye made from the seed of achiote

mercurials

What preservative group works by the denaturation of enzymes by combining with thiol (-SH) groups?

pull seal

Ampoule sealing method by melting enough glass at the tip of the neck of an ampoule to form a bead and close the opening

Type III

Which type of glass container is composed of Sodium and Calcium oxide

10

Sample size for torque testing of caps and closures

sterile room

room/area of defined environmental condition with controlled particulate and microbial contamination; constructed, equipped and used to eliminate the introduction on, generation or retention of contaminants

toll manufacturer

manufacturer who produces the products of a company without manufacturing facilities is a/ an:

aerosol containers

only true tamper resistant packaging:

water for injection

Purified water that is free from pyrogen

SSS316

most inert grade of stainless steel used for high grade products

granules

Aggregates of powders which adhere or bond to each other to form larger particles

35-50% RH

Storage conditions for capsules

binder

Substance that “glue” powder together causing them to form granules

lubricant

agent that acts between surfaces in relative motion to prevent friction and wear

sweating

film coating, when additives migrate to the surface, the problem is called:

airlock

anteroom which separates the sterile from non sterile is a/an:

Class 100

Area with no more than 100 particles of 0.5 micron size per cubic foot of environment:

LAL test

very simple, sensitive and fast test for pyrogens using the amoebocyte of the horse shoe crab.

pull sealing and tip sealing

ampules are sealed by

water soluble base

PEG is an

Sigma blade mixer

Mixing equipment for acid materials

flocculation

aggregation of the dispersed globules into loose clusters within the emulsion

Current Good Manufacturing Practice

cGMP means

QA

Group which is responsible for auditing the control system for evaluating product quality