1 Pharmaceutical factory is developing the new product release. What part of technological rules describes the appearance, physical and chemical properties of finished product?
A *Characteristic of the final product
B Information data
C Description of technological process
D Characteristic of raw materials and intermediate products
E Characteristic of auxiliary products
2 Tablets which are manufactured by method of forming of wet masses is named:
A * Trituration tablets
B Tablets with covering
C Tablets without covering
D Tablets with the pellicle covering
E Tablets with the pressed covering
3 One of new medical forms of industrial production, that used in child's practice and intended for little
children which cannot swallow tablets is:
A* Tubatines
B Dragee
C Spansules
D Medules
E Granules
4 Specify the method of application of oriblettae - tablets:
A* Peroral
B For preparation of suspensions
C For implantations
D Vaginal
E For preparation of solutions
5 Different types of auxiliary matters are applied at the production of tablets. Specify what matters are
applied to cover the intestinal-soluble covering?
A * Acethylphtalylcellulose, schellak, caseinum
B Polyaethylenoxydum, polyvinylpyrrolidone, methylcellulose
C P – aminobenzoatum, polyaethylenoxydum
D Ethylcellulose, caseinum
E Polyaethylenoxydum, aminobenzoatum,
6 Specify time of disintegration of tablets without covering.
A * Not more than 15 minutes
B Not more than 5 minutes
C Not more than 10 minutes
D Not more than 20 minutes
E Not more than 30 minutes
7 Specify an apparatus which are applied for packing of powders.
A * Screw and vacuum metering devices
B Dezintegratore
C Dismembratore
D Screw dosage machines
E Vacuum dosage machines
8 Specify, what are diluents used in the production of pills for?
A For providing of certain mass of pills
B For providing of stability of pills
C For tabletting of drastic matters
D For providing of mechanical durability
E For giving the pills of certain properties
9 Specify time of disintegration of pills with intestinal-soluble covering according to the requirements of
pharmacopoeia
A *Not more than one hour in alkaline solution of sodium hydrocarbonate
B Not less than 50 minutes in alkaline solution of sodium hydrocarbonate
C Not less than 30 minutes in alkaline solution of sodium hydrocarbonate
D Not more than 40 minutes in alkaline solution of sodium hydrocarbonate
E Not more than 15 minutes in alkaline solution of sodium hydrocarbonate
10 Specify time of disintegration of pills without covering according to the requirements of pharmacopoeia
A Not more than 15 minutes
B Not more than 30 minutes
C Not more than 45 minutes
D Not less than 30 minutes
E Not less than one hour
11 What normativ document is confirmed on the limited term and which sets requirements to quality of
remedy and raw materials
A *The temporary article of pharmacopoeia
B The technological industrial regulation
C The article of pharmacopoeia
D The state standard
E The Industry standard
12 Give definition of medical form of tubatines:
A *Soft capsules with the prolonged neck.
B Capsules of spherical form
C Capsules of ovate form
D Hard capsules with a lid and microcapsules.
E Soft rectal capsules of prolate form.
13 What is method used to prepare the pills of sodium chloride?
A * Direct (simple) pressing;
B Granulation;
C Wet granulation;
D Preliminary granulation
E Dry granulation.
14 Specify the basic methods of tablets preparation.
A * Pressing, forming
B Pressing, outpouring
C Forming, granulation
D Pressing, wet granulation
E Pressing, granulation
15 Normative document which sets the requirements to the products and services, and regulates the
relations between a supplier and user
A * Technical requirements;
B Standard;
C Technical regulation;
D Technological regulation;
E Methodical pointing.
16 What auxiliary matters improve disintegration or dissolution of pills in an organism?
A * Disintegrating agents
B Glidents;
C Binders;
D Diluent;
E Matters to correct defects.
17 What group of high-quality descriptions of pills such signs behave to: form of pills, mass of pill, indexes
of durability, porosity?
A * Physical indexes;
B Chemical indexes;
C Physical and chemical indexes;
D Bacteriological;
E Biological.
18 In what amount is Twin-80 added at the production of pills
A * Not more than 1 %
B Not more than 0,5 %
C Not more than 3 %
D Not more than 5 %
E 10 %
19 What kind of covering permits to manufacture the tablet and covering at the same time?
A *Pressed covering
B Pellicle coverinf
C Dragee coverage
D Multi-layered covering
E Mouldable covering
20 By what method are soft capsules expediently made if gelatinous mass is prepared with the swelling
stage of gelatin?
A *By a pressing method;
B By a drop method;
C By the method of immersion;
D By the method of dispersion;
E By the method of dragee using.
21 What method expediently to use in an order to place the medicinal matter in gaseous form in a covering
of microcapsule?
A *Coacervation;
B Method of dragee using;
C Dispersion;
D Dispergation;
E Polymerization.
22 The main trend in developing of new drugs is based on:
A *Managing of drug substance delivering into the target organ (tissue).
B Creating of new synthetic cytostatics and antiviral agents.
C Reducing the amount of accompanying substances in dosage forms.
D Increasing of radiopharmaceuticals for diagnostic procedures.
E Replacing of synthetic drugs with phytochemicals.
23 Choose the correct order of generic drug development.
A *Study of the active substance, elaboration of drug composition &technology, drug testing, technology scaling, validation by the Pharmacological Committee, clinical trials, affirmation of the reference documentation.
B Study of the active substance, elaboration of drug composition & technology, clinical trials, validation by the Pharmacological Committee, drug testing, technology scaling, affirmation of the reference documentation.
C Study of the active substance, drug testing, elaboration of drug composition & technology, clinical trials, validation by the Pharmacological Committee, affirmation of the reference documentation, technology scaling.
D Elaboration of drug composition, study of the active substance, clinical trials, drug testing, validation by the Pharmacological Committee, technology scaling, affirmation of the reference documentation.
E Study of the active substance, elaboration of drug composition & technology, drug testing, technology
scaling, affirmation of the reference documentation, validation by the Pharmacological Committee, clinical trials.
24 Phytochemicals get an increasing popularity, because:
A *Phytochemicals have a wide range of therapeutic action and could be prescribed for long-term
treatment of chronic diseases.
B They are sold in drugstores without any prescription.
C Phytochemicals are the drugs of choice for treatment of acute severe diseases and could be administered in high doses.
D They are much cheaper than synthetic analogues.
E Plant drugs could replace their synthetic analogues.
25 Choose the groups of phytochemicals which need to be developed of first priority in Ukraine:
A *Neurological and dermatologic drugs.
B Antimicrobial preparations.
C Cardiovascular agents.
D Gastroenterological drugs.
E Antiflogistics and analgetics.
26 Pharmaceutical factory is developing a new product release. Which part of technological rules
describes the appearance, physical and chemical properties of finished product?
A *Characteristic of the final product
B Description of technological process
C Characteristic of raw materials and intermediate products
D Characteristic of auxiliary products
E Information data
27 Which part of rules describes sanitary preparation of industrial premises:
A *Description of the stages of technological process and industrial sanitation
B Safety technique activity and environment control
C Safety technique, fire safety and industrial sanitation
D Information data
E General characteristic of manufacture
28 Industrial technical department elaborates technical rules. Several units of equipment have been
changed. Which part of technical rules should be changed immediately?
A *An equipment flowchart
B Table of MPC (maximum permissible concentration)
C Part of labour protection
D Plan of breakdown elimination
E List of instructions
29 Various preparations are produced in a pharmaceutical factory according to technological rules. How
long is industrial manufacturing rules are valid?
A *5 years
B 1 year
C 3 years
D 8 years
E 6 months
30 A reference document that establishes requirements to particular production and service and regulates relations between a supplier and a customer. Which term corresponds to this determination?
A *Technical requirements
B Standard
C Technical rules
D Technological rules
E Methodical instructions
31 Reference document establishing the requirements for quality monitoring of a drug product, its packing, storage conditions and shelf-life is called:
A *Analytical reference documentation or monograph;
B Manufacturing and technical rules
C State standards
D Branch standards
E Operating instructions
32 Normative document describing the consequence of all operating procedures and equipment used,
establishing all manufacturing parameters and sites of quality monitoring and containing specifications on starting materials, intermediates and final products is called:
A *Manufacturing rules
B Analytical reference documentation or monograph;
C State standards
D Branch stnandards
E Specificatios
33 Preparing of laboratory, pilot and manufacturing premises and the personnel for work; sanitary-and-
hygienic conditioning of manufacture; the requirements for occupational safety, safety precautions, fire safety, environment control; equipment operation are described in:
A *Technical rules
B State standards
C Manufacturing rules
D Analytical reference documentation or monograph
E Operating instructions
34 Flowchart illustrating consequence of stages and operations in manufacturing process is called:
A *Manufacturing flowchart
B Equipment flowchart
C Chemical scheme
D Biological scheme
E Material flowchart
35 In what chapter of manufacturing rules we can find information about composition, physico-chemical
and pharmacological properties of a drug:
A *The characteristic of a finished product
B In-process control
C Manufacturing flowchart and operation process
D Appendices
E Information supplements
36 An active ingredient permitted for medical use, intended for incorporation into a finished dosage form, that meets the statutory definition of a drug is called:
A *Drug Substance
B Crude drug
C Drug formulation
D Drug Product
E Dosage form
37 In material balance exhausted herb is included into:
A *Rejects
B Intermediate products
C Material losses
D By-products
E Waste products
38 Plaster is medical form for external application and is produced in:
A *The hard masses and as liquids.
B Hard mass.
C Liquid and soft.
D Hard mass and as gel.
E As liquids.
39 What stages does the technological process of mustard plasters production consist of?
A * Preparation of rubber glue, preparation of mustard mass, spreading the masses on paper, drying, packing, recuparation of petrol
B Preparation of mustard mass, spreading of mass is on paper, exposition of mustard plasters in a pile, packing
C Preparation of rubber glue, preparation of mustard mass, recuperation of petrol
D Preparation of mustard mass, spreading of mass on the paper, packing
E Preparation of rubber glue, spreading of mass on paper, drying, packing
40 There is ointments are made on the pharmaceutical enterprise. Specify what bases are used for simple
sulphur ointment (Unguentum Sulphuris).
A *Emulsion
B Vaseline
C Basis „ for eye ointments”
D Lanolin
E Lanolin + vaseline
41 Adding the auxiliary matters provides a hardness of rectal suppository. Select an auxiliary matter which provides this property.
A* Cacao oil
B Glycerin
C Paraffin;
D Vaseline
E Dry powders
42 What are concentrates used at suppository formulation
A * Solutions or suspensions of medicinal matters, which are entered in basis
B Concentrated solutions of medicinal matters which are prescribed in a few amount
C Chemist's preparations of medicinal matters
D Medicinal matters that soluble in basis
E Medical bases, that water-soluble
43 What apparatus can be used on the stage of ointment packing:
A *Screw and piston measuring and filling machines
B Automat of Rezepina
C Rotor machines
D Eccentric machines
E Disk machines
44 The ointment department of the factory produces ointments. Specify a technological operation which provides an homogeneity of medicinal substances distribution in a basis:
A *Homogenization
B Preparation of basis
C Standardization
D Filling
E Packing
45 The ointment department of the factory produces ointments (gels) on water-soluble bases. Specify a
component for their obtaining:
A *Methylcellulose
B Hydrogenated lipids
C Silicon
D Vaseline
E Beeswax
46 The ointment department of the factory produces heterogeneous ointments. Choose an apparatus,
necessary for homogenization of ointments.
A *Three-roller ointment grinder, rotor-pulsation device (RPD)
B Electro-panel for melting of bases
C Reactor-Mixer
D Mixer with blade mixers
E Disintegrator
47 What equipment is used at the ointments production of is it possible to attain the high degree of
homogenization?
A* RPD
B Propedeutics mixer
C Autolyzer
D Barboter
E Anchor mixer
48 The ointment department of the factory produces zinc ointment. the technological stage -
homogenization is conducted. What apparatus is utilized for homogenization of this ointment?
A Electro-caldrons
B Mixers with anchor mixers
C *Be- and three-roller ointment grinder, RPD
D Caldrons with steam heaters
E Drum mills
49 The ointment department of the factory produces a sulphuric ointment. At a production of 100 kg of
ointment were got 97 kg of the finished product. What were the production losses?
A 13 %
B 0,3 %
C 5 %
D 10 %
E *3 %
50 The ointment department of the factory produces a new ointment. Choose the flowsheet of production:
A *Preparing of medicinal substances and bases, loading medicinal substance into a basis, homogenization,
standartizing, dispensing, labelling and packaging.
B Melting of a basis, homogenization, loading of medicinal substance into a basis, labelling and packaging, standartizing
C Loading of medicinal substance into a basis, melting of a basis, standartizing homogenization, labelling and packing,
D Melting of a basis, homogenization, loading medicinal substance into a basis, standartizing, packaging,
labelling and packing
E Melting of a basis, loading medicinal substance into a basis,
homogenization, dispensing, labelling and packing, standartizing
51 The ointment department of the factory produces ointments-creams on water-soluble bases. Choose
components for this type of bases:
A *Semisynthetic derivates of celluloses, polysaccharides of microbal origin, gelatin-glycerin bases,
polyethilenoxides bases
B Lipides, hydrogenated lipides, vegetable and mineral oils, beeswaxes, hydrocarbon bases, silicon bases
C Emulsive bases, Semisynthetic derivates of celluloses, polysaccharides of microbal origin,
D Gelatin-glycerin bases, polyethilenoxides bases, lipides, hydrogenated lipides, vegetable and mineral oils, beeswaxes
E Emulsive bases, hydrocarbon bases, silicon bases
52 The ointment department of the factory produces semisolid medicinal forms. For homogenization of
ointments apply a rotor-pulsation device. Application of rotor-pulsation device allows to combine:
A *Grinding of powdery components, homogenization of ointment
B Standardization of medicinal form, melting of basis
C Melting of basis, previous grinding of powdery components
D Homogenization of ointment, packing and labeling of ointment
E Packing of ointment, melting of basis
53 What apparatus can be used on the stage of ointment packing :
A *Screw and piston measuring and filling machines, tube-feeding automats of linear and rotary types
B Automats of the continuous forming, screw and piston batchings machines
C Automat of Rezepina, pipe, piston, disk batchings machines
D Rotor machines, eccentric machines , tube-feeding machines
E Screw and piston measuring and filling machines
54 In the manufacture of soft drug formulations rotary-pulsating devices are frequently used. What
operations are carried out on this equipment?
A *Preliminary milling of powdery materials, homogenization of soft dosage forms
B Standartizing of a dosage form, melting of a soft drug formulation basis
C Melting of a basis, preliminary milling of powdery components
D Homogenization, dispensing and packing of soft dosage forms
E e. Dispensing and packing, melting of a soft dosage form basis
55 Define the correct sequence of technological operations in production of liniments, ointments and
pastes:
A *Preparing of medicinal substances and bases, loading medicinal substance into a basis, homogenization, standartizing, dispensing, labelling and packaging
B Melting of a basis, homogenization, loading of medicinal substance into a basis, labelling and packaging, standartizing
C Loading of medicinal substance into a basis, melting of a basis, standartizing homogenization, labelling and packing
D Melting of a basis, homogenization, loading medicinal substance into a basis, standartizing, packaging,
labelling and packing
E Melting of a basis, loading medicinal substance into a basis, homogenization, dispensing, labelling and
packing, standartizing
56 What is sugar syrup used for?
A * For expectorant and purgative using
B As taste syrup
C As purgative remedy
D As cardio-vascular remedy
E As diuretic remedy
57 Specify a method to determin the concentration of ethyl spirit in spirituous solution
A *By the temperature of boiling
B By the dry remainder
C By cryoskop method
D By polarimeter
E By weight method
58 Syrups without medicinal matters are used for:
A * Correct, as agglutinative matters
B As solvents for preparation of liquid medical forms
C As basis for preparation of unwater medical forms
D As emulgator
E As stabilizer
59 What isn’t method used at the production of ether oils in an industrial production:
A * Method of extractin
B Pressing method
C Method of hydrodistillation
D Method of extraction
E Method of distillation
60 Specify, what is oil as solvent used to prepare of oil camphor?
A * Sunflower-seed oil
B Peachy
C Vaseline
D Olive
E Plum
61 Specify the features of preparation of magnesium sulfate solution.
A * Preparation the solution of higher concentration and cleaning from the admixtures of manganese and salts of iron
B Preparation of solution without thermal sterilization
C Preparation of solution of higher concentration and cleaning from the admixtures of calcium sulfate and iron
D Dissolution of medicinal matter using the heating and cleaning from the admixtures of calcium
E Preparation of solution with thermal sterilization
62 Specify in what proportion fennel water is prepared.
A * 1:1000
B 1:2000
C 1:4000
D 1:10
E 1:1
63 Which are liquid medical forms used for irrigation of cavities of body, wounds and surfaces?
A * Irrigations
B Nasal medications
C Liquid medications
D Shampoo
64 What type of mixers is used for speed interfusion of solutions with small density?
A * Spiral mixers;
B Planetary mixers;
C Turbine mixers;
D Anchor mixers;
E Drum mixers.
65 Which are syrups used to improve taste qualities basic medical matters of medicinal preparations?
A * Sugar syrup;
B Althaea syrup;
C Syrup from rhubarb;
D Syrup from liquorice;
E Syrup of wild rose.
66 A pharmaceutical factory produces aromatic water. Select apparatus necessary for production of
aromatic water by distillation method:
A *Distillation still with a stem jacket, bubbler, cooler, distillate collector
B Mixer, distillation still, distillate collector
C Bubbler, cooler, distillate collector
D Herb cutter, distillation still, cooler
E Mixer with blade agitators, filter, distillate collector
67 Wetting of raw material lasts 12 hours at production of bitter almond water for hydrolysis of:
A *Amigdalin
B Lipids
C Proteins
D Sinigrin
E Sugars
68 On an factory produce medicinal syrups. Name, what syrup is utillized as basis:
A *Saccharine
B Cherry
C Raspberry
D Pieplant
E Licorice
69 Sugar syrup is filtered in the hot state with a purpose of:
A *Accelerations of filtration process
B Preventions of microbial contamination
C Preventions of sugar crystallization
D Moisture remove
E Increases of syrup viscidity
70 For preparation of syrup utillize 82 parts of sugar syrup; 1 part of KJ (KBr); 12 parts of liquid Thýmus
extract and 5 parts 96% ethanol. How is this preparation named?
A *Pertussinum
B Cholosasum
C Ambroksol
D Bronkholitin
E Syrup of licorice
71 What role plays an inverted sugar in syrup of wild rose?
A *Stabilizator of vitamin C
B Prevents a gelforming
C Solvent for vitamin C
D Prevents coagulation of peptides and pectins
E Prevents fermentation
72 What syrup is used for taste abilities of active substances improvement?