[PHARMACEUTICAL MANUFACTURING] PACOP PINK

C

A class of raw materials, which are to be subjected to tests and assays by the Quality Control

department, and are not yet to be use in the production of pharmaceuticals;

A. Approved for use materials C. Quarantined materials

B. Rejected materials

D

A standard document, which give instructions to the Production Department to produce a pharmaceutical

product for distribution/sale in the market;

A. Batch Production Record C. Master Formula

B. Finishing Order D. Manufacturing Order

C

A section of the warehouse which houses products which have been bottled, stripped or blister-packed,

but not yet labelled or packed into boxes/cartons. And are still awaiting the final disposition of the Quality

Control Department;

A. Finished Goods Section C. Returned Goods Section

B. In-Process Section D. Raw Materials Section

A

The Planning and Scheduling Division coordinates with this department on what products are required for

supply and market distribution, then plans and schedules the manufacture of the product;

A. Marketing C. Inventory Control

B. Purchasing D. Production Control

A

A method of filling liquids wherein the product is pumped, at constant pressure, through an orifice of

constant diameter and size. The fill amount is measured by the stroke of the piston;

A. Volumetric

B. C. Gravimetric

C. Constant level

D

An important parameter in the quality control of tablets, shown to be related to the tablet's solubility

properties;

A. Tablet Thickness C. Filter cloth, non-woven

B. Tablet Disintegration D. All of the above

A

A special technique for poorly-soluble drugs, in which it is improved by the addition of a water-miscible

solvent, in which the drug will have increased water solubility;

A. Solubilization C. Complexation

B. Chemical modification D. Co-solvency

B

A class of preservative, which are often used for ophthalmic, nasal and parenteral products, but in oral

liquid preparations;

A. Mercurials C. Aldehydes

B. Quaternary ammonium compounds D. All of the above

A

A filter media composed of nylon, Teflon, PVC and silver. It is employed fo the micro-filtration of

parenteral solution;

A. Membrane Filter Media C. Filter cloth, non-woven

B. Filter cloth, woven D. All of the above

D

The following are the effects of Product Recalls to a drug-manufacturing firm;

A. Financial Loses C. Harmful and Bad Publicity

B. Mix-ups and Errors D. All of the above

D

Overages in the manufacture of pharmaceuticals are justified on the ff. conditions;

A. Clinical studies show that the average is therapeutically safe

B. The labile/unstable active cannot be possibly standardized

C. The overage allows for the equilibrium of the active within acceptable limits

D. All of the above

B

It refers to the addition of an active in an unstable pharmaceutical preparation, to compensate for the loss

during manufacture;

A. Chemical modification of the drug C. Manufacturing allowances

B. Manufacturing Overages D. All of the above

C

It refers to the rapid formation of emulsion droplets or aggregates due to the absence of a protective

barrier at the oil-water interface and the insufficient emulsifier surface overage;

A. Creaming C. Flocculation

B. Sedimentation D. Coalescence

D

For the pharmaceutical emulsions, the oil phase is restricted to this oil, unless otherwise, it is the specified

active of the product;

A. Olive oil C. Cottonseed oil

B. Corn oil D. Mineral oil

B

A class of finely divided solids that influence emulsification of polar solids by its tendency to be wetted by

water, and to be wetted by the oil phase of non-polar solids;

A. Eggyolk, cholesterol, gelatine C. TWEENS, SPANS, Carbowax

B. Bentonite, veegum, magnesium trisilicate D. All of the above

D

Examples of antioxidants incorporated into cosmetic type of emulsion;

A. Butylatedhydroxyanisole C. Butylatedhydroxytoluene

B. Tocopherol D. All of the above

B

An equipment thet mixes the components of emulsions by means of various impellers on shafts, which

are placed directly into the system to be emulsified;

A. Rotor stator C. Mechanical stirrers

B. Colloid mill D. ultrasonifiers

A

Raw materials of hydrocarbon nature, which are widely used in the manufacture of semi-solids, next to

water;

A. Petroleum jelly C. White wax

B. Mineral oil D. Paraffin

D

Raw materials which are widely used as humectants in semi-solids to prevent "crusting" in ointment and

creams contained in jars;

A. Glycerin C. Sorbitol, 70%

B. Propylene Glycol (low MW) D. All of the above

A

An absorption type of an ointment used for ophthalmic preparations;

A. Soft petroleum, sterile C. Lanolin, anhydrous

B. White wax D. Ozokerite

A

A method of manufacture of anhydrous ointments wherein the active/s are dissolved in the previously

melted mixtures of fats and waxes, at controlled temperatures;

A. Fusion method C. Levigation

B. Trituration/incorporation D. All of the above

C

A type of stability test, which involves temperatures in 10-degree increments. This test is performed to

identify the products of degradation of a product;

A. Real time stability test C. Stress test

B. Accelerated stability test D. All of the above

B

A method of preparation of suspensions, wherein finely divided powders are dispersed in an appropriate

liquid vehicle, with the aid of a surfactant, to ensure uniform wetting of hydrophobic surfaces;

A. Precipitation method C. Double decomposition

B. Dispersion method D. All of the above

A

The cause of capping, chipping and lamination of compressed tablets;

A. Wear and tear punches and die cavities

B. Difficulty in cleaning monograms which enclosed areas

C. Poor flow rate of granulations

D. Unequal lengths of the lower punches

C

In precipitation method of preparing suspensions, particle size control is important. For suspensions

intended for parenteral and inhalation us, the ideal particle size range is;

A. 1 micron and below C. 1 to 5 microns

B. 5 to 8 microns D. 8 to 10 microns

D

This equipment produces finely divided particles by spraying a mist of liquid through a heated chamber,

drying immediately and collecting the dried powders in a clean receptacle;

A. Micronization C. Freeze-drying

B. Homogenization D. Spray-drying

B

A parenteral route of administration in which an aqueous solution is preferred for optimum absorption. It

produces instantaneous pharmacological effect, since the drug is directly introduced into the bloodstream;

A. Intraspinal C. Intramuscular

B. Intravenous D. Subcutaneous

D

The potential sources of pyrogens in the manufacture of parenterals;

A. Contaminated water and solutes C. Contaminated equipments

B. Manufacturing methods D. All of the above

D

Air sampling techniques used for the environmental control test in the parenteral work area;

A. Collection of particulate matter, by drawing a sample through a clean sterile membrane filter

B. Collection of air sample into a measured volume of nutrient broth agar in an impinge

C. Drawing measured volume of air through a slit sampler

D. All of the above

B

An equipment, which allows for the draft-free flow of air cover over the parenteral work area, by providing

a total sweep of the confined area;

A. HEPA filter C. Membrane filter media

B. Laminar flow enclosure D. All of the above

D

When filling sterile powders into vials, the filling equipment employs a/an____in the sem of the funnel at

the bottom of the hopper. It regulates the volume of granular material into the vial to avoid clogging;

A. Indexing stars C. Filling wheel

B. Augers D. both B and C

D

Process/es that give/s rubber closure less friction, to enable easier mechanical insertion onto vials;

A. Halogenization C. Carbonization

B. Siliconization D. Both A and B

B

A more effective method of sterilization. Killing microorganisms through coagulation of its cell protein. It

also destroys vegetative forms of bacteria and spores at 121 C for 20 minutes at 20 psi;

A. Dry heat method C. Fractional method

B. Moist heat method D. Gas sterilization method

A

A non- thermal form of sterilization, which is used in the reduction of air-borne microbes, roduced by

mercury vapour lamps. This method has poor penetration capability;

A. Ultraviolet radiation C. Inspissation

B. Ionization method D. Tyndallization

B

An in-vitro method of pyrogen test based on the gelling or color development of pyrogenic preparation in

the presence of lysate on the amoebecytes of the horseshoe crab;

A. Qualitative fever response in rabbits

B. Limulus method

C. Qualitative fever response in mice

D. All of the above

C

Most biological are store at this temperature;

A. 2 - 8 °F C. 2 - 8 °C

B. 12 - 8 °F D. 12 - 8 °C

D

Parenteral products, which should be packed as single-dose medication;

A. Intraspinal C. Epidural

B. Intracisternal D. All of the above

D

Examples of primary packaging components;

A. Rubber stoppers C. Blister/strip packs

B. Cotton fillers D. Both A and B

D

A mechanism involved in the preparation of sustained release tablets, wherein the drug material is

applied with relatively thin coating material, ranging from several tenths of micron to 5000 microns in size;

A. Use of ion-exchange resins

B. Embedding the drug in a slowly eroding matrix

C. Embedding the drug in a plastic matrix, from which it is leached

D. Microencapsulation

B

A part of tablet press, which distributes the granulation material into the die cavities;

A. Hopper C. Upper and lower punches

B. Feed shoe/frame D. Auger

A

An ideal property of tablet granulations in which the material forms a stable, compact mass when

pressure is applied;

A. Compressibility C. Flow rate

B. Fluidity D. All of the above

C

The preferred bulking agent for chewable tablets, which provides an excellent mouth-feel, due to its

pleasant, cooling effect;

A. Sucrose C. Mannitol

B. Microcrystalline cellulose D. Lactose

D

This raw material can be used as a tablet diluents, disintegrant and binder;

A. Avicel C. Celutab

B. Lactose D. Cornstarch

D

The ff. statements are true for glidants/lubricants in tablet granulation;

A. Oppose the efficiency of the binder and the physical forces that act under compression

B. Cause the adhesion of powder to form granules

C. Causes a compressed tablet to break apart when placed in an aqueous medium

D. Reduce interparticulate friction, thereby improving the rate of flow of granulation

B

Carbowax 400, leucine, talc and colloidal silicon dioxide are employed as____.

A. Diluents C. Granulating agent

B. Lubricant D. Disintegrant

A

A method of preparation of tablets whose components are sensitive to moisture and elevated temperatures, during drying, yet possess inherent cohesive properties;

A. Dry granulation method C. Pre-compression method

B. Direct compression D. All of the above

A

A method of preparing tablet granulations, wherein the powders are de-aerated and passes between two

rollers, forming a thin cake, which is screened to form granules;

A. Use of chilsonator C. Spheronization

B. Slugging D. Pelletization

A

An equipment, which alternatelycombine and draw apart the tablet material, as this equipment revolves.

Ideal for precise blending of dry-to-dry or dry-to-liquid materials, with short processing times;

A. Twin or V Shell Blender C. Conical Blender

B. Planetary Blade Mixer D. Horizontal Ribbon Mixer

C

An equipment, which delivers a reliable and uniformly mixed dried product, without the necessity for premixing. It produces a dry granulation from a wet powder mix;

A. Tray Dry Oven C. Granulator/Fluid Bed Dryer

B. Tablet Deduster D. All of the above

C

The critical operation in sugar coating process of tablets leading to a 50% to 100% increase in tablet

weight. This is the basis of an elegant tablet profile;

A. Sealing C. Subcoating

B. Smoothing D. Color coating

A

An enteric film-former material, which is not soluble in a slightly acid pH media;

A. Shellac flakes C. Cellulose acetate phthalate

B. Povidone D. Carboxymethylcellulose

C

It refers to the separation of the concentrated emulsified droplets from the discontinuous phase;

A. Flocculation C. Creaming

B. Coalescence D. Sedimentation

C

A type of gelatine blend, which contributes to plasticity and clarity to the blend, thus reducing haze or

cloudiness of the finished capsules;

A. Calf skin gelatine C. Pork skin gelatin

B. Calf bone gelatine D. Hydroxypropylmethylcellulose

B

The most common method of manufacture of hard gelatine capsules that uses completely automatic

machine, consisting of mechanisms for dipping, spinning, drying, stripping and joining the capsules;

A. Plate process C. Rotary Die method

B. Pin method D. Reciprocating Die method

A

The temperature at which empty hard gelatine capsules should be stored;

A. 100 °F C. 100 °C

B. 70 °C D. 70 °F

D

Aside from the property of fluidity, tablet granulations should also possess;

A. Flowability C. Solubility

B. Cohesiveness D. Compressibility

D

Pharmaceutical suspensions are evaluated by;

A. Particle size measurement C. Sedimentation volume

B. Viscosity D. Colloidal power

A

The coalescence of globules in an oil-in-water emulsion is an indication of;

A. Cracking C. Creaming

B. Flocculation D. Phase intervention

D

An adjunct used to prevent topical preparations from drying out of forming a "cruct" of the surface;

A. Sweetening agent C. Emollient

B. Preservative D. Humectant

B

Anteroom, which separates the sterile areas from non-sterile areas;

A. Laminar Flow enclosure C. Air curtain

B. Air lock D. HEPA filter

A

CGMP means;

A. Current Good Manufacturing Practice

B. Current General Manufacturing Program

C. Current General Manufacturing Practice

D. Current Good Manufacturing Program

D

Suppositories are made by;

A. Fusion or melt molding C. Cold compression

B. Rolling or hand-shaping D. Any of the above

A

USP requires that Dissolution Test should be carried out at;

A. 36.5 to 37.5 C C. 25 - 30 C

B. 39 C D. Any of the above

C

LAL stands for;

A. Limulus Antibiotic Lysate C. Limulus Amoebocyte Lysate

B. Lyophilized Antibiotic Lysate D. Lyophilized Amoebocyte Lysate

D

In real Time stability studies, the climatic conditions of the Philippines is classified as;

A. Mediterranean C. Hot and Dry

B. Temperate D. Hot and Humid

B

Long term stability studies, is also known as;

A. Accelerated stability studies C. Stress Tests

B. Real Time stability studies D. Validity studies

D

Directly Compressible grades of Lactose include;

A. Spray-Dried Lactose C. Anhydrous Lactose

B. Dehydrated Lactose D. All of the above

C

Sterilization technique. Which makes use of ethylene oxide-beta propiolactone or propylene oxide,

usually for plastic containers;

A. Steam sterilization C. Gas sterilization

B. Dry heat sterilization D. Surface Disinfection

A

Diluents of choice or chewable tablets;

A. Mannitol C. Lactose

B. Sorbitol D. Dextrose

D

Strip-sealed tablets are evaluated for;

A. Clarity C. Hardness

B. Thickness D. Leakers

A

An equipment associated with the maintenance of dust-free;

A. Laminar Flow Hood C. Ultra Violet Lamp

B. Autoclave D. Magnetic Resonance

C

Binder of choice for moisture-sensitive materials;

A. Ethylcellulose C. Gelatin solution

B. Starch paste D. Glucose solution

C

An adjunct necessity for oral liquids to prevent bacterial contamination;

A. Antioxidants C. Preservatives

B. pH stabilizers D. Buffers

D

"Rule of Thumb" is the principle applied for testing;

A. Ampules C. Vials

B. Implantations D. Compressed Tablets

A

Thermolabile products in solution is sterilized by;

A. Membrane filtration C. Autoclaving

B. Gas sterilization D. Gamma radition

D

A tablet formulation contains 2 actives, which are chemically incompatible. The best method to be used

is;

A. Dry granulation C. Wet granulation

B. Slugging D. Multiple-Layered compression

D

Freeze-drying is also known as;

A. Dessication C. Evaporation

B. Exsiccation D. Lyophilization

B

According to the USP, single dose containers of parenterals are limited to fill volume of;

A. 1000 ml C. 250 ml

B. 500 ml D. 1500 ml

D

In the preparation of effervescent tablets, the component/s necessary for the effervescent effect is/are;

A. Sodium bicarbonate C. Tartaric acid

B. Citric acid D. All of the above

D

Manufacturing tanks of oral liquids are usually constructed of;

A. Glass C. Galvanized Iron

B. Aluminium D. Stainless Steel

B

Eggyolk, an emulsifier belongs to;

A. Synthetic group C. Finely Divided solid group

B. Natural group D. Non-ionic group

D

Uneven distribution of color on the surface of compressed tablets is called;

A. Peeling C. Mottling

B. Capping D. Lamination

B

Parenteral solutions intended to be freeze-dried should be;

A. Alcoholic C. Oleaginous

B. Aqueous D. Any of the above

C

A common lubricant added to tablet granulation;

A. Starch C. Magnesium stearate

B. Mannitol D. Acacia

B

Limulus amoebocyte lysate is obtained from;

A. Rabbits C. Albino mice

B. King crab D. Microorganism

A

A broad-spectrum preservative effective against bacteria and molds;

A. Parabens C. Sodium benzoate

B. Alcohol D. Glycerin

A

Inconsistent thickness of tablets could result to problems regarding;

A. Packaging C. Disintegration

B. Dissolution D. Hardness

A

Stoke's Monsanto tester is used to measure___of tablets;

A. Friability C. Disintegration

B. Thickness D. Hardness

D

Stoke's Monsanto tester is used to measure___of tablets;

A. Friability C. Disintegration

B. Thickness D. Hardness

B

In the manufacture of emulsified semi-solids, the mixing of the oil aqueous phases should be at this

temperature to avoid breaking;

A. 30 to 40 °C C. 80 °C

B. 70 to 72 °C D. 40 to 43 °C

D

The bioavailabilty of a compressed tablet is dependent upon its;

A. Weight variation C. Content unifomity

B. Disintegration time D. Dissolution

C

An inert gas usually incorporated in filling ampoules;

A. Hydrogen C. Nitrogen

B. Oxygen D. Ethylene oxide

B

The normal moisture content of hard gelatine capsules;

A. 2 to 5% C. 20 to 24%

B. 12 to 16% D. 25 to 30%

C

This statement is tru of the FIFO Policy;

A. Contains information regarding the activity of the component

B. Prevents contamination and mix-ups

C. Assure that the oldest stock of material is used first

D. All of the above

B

Which of these is the adverse effect of a product recall?

A. A function of biological testing in a laboratory

B. Should be filed by a dissatisfied customer

C. Inflicts damage on the reputation and good standing of the company

A

Which of the ff. Is the function of Research and Product Development Department?

A. Pilot Batch production C. Manufacture and packaging

B. In-process quality testing D. Clinical testing

D

Pyrogens contaminating glasswares can be destroyed at this setting;

A. 121 C for 20 minutes C. 200 C for 1 minuteB. 180

C for 1 hour D. 650 C for 1 minute

A

Water soluble bases for medicated application are prepared from;

A. Polyethylene glycol C. Petroleum jelly

B. Sorbitol D. Mineral oil

D

A solid dosage form, which does not need to conform to USP disintegration time;

A. Film-coated tablets C. Enteric-coated tablets

B. Sugar-coated tablets D. Chewable tablets

B

An instrument used to check the tightness of the caps/closure;

A. pH meter C. Crimper

B. Torque tester D. Implinger