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El-SaFwa Group 2016 Industry Questions

Important questions

A) Answer the following questions:


1. Compare between unit process & unit operation.
2. Draw a diagram showing drug development in pharmaceutical industry, and in tabular
form discuss the different phases of drug development.
3. Why do we need GMP.
4. How do branded companies protect their products against generic competition.
5. Give reason:
a. Physical properties of substances should be reviewed before milling.
b. Weighing and dispensing should be performed in a partitioned area with good ventilation
c. Distillation is carried out under vacuum
d. Centrifugal extractors may be used for separation of 2 liquid phases

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e. The crystallizer should be located directly above the filtration device
6. Discuss 2 methods of tablet compression.

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7. Enumerate the top 5 companies by 2010 sales.
8. Discuss: blending & granulation.
9. Discuss: crystallization & evaporation.
10. Types of Audit.

B) Discuss briefly each of the following:


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1. collapsible tubes
a
2. Media fill.
3. Blister packaging.
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4. Different types of glass.


5. Mechanical & optical properties of glass
6. Advantages of blow/fill/seal technology.

C) Write on:
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1. Advantages & disadvantages of activated sludge system.


2. Define BOD5.
3. Compare between aerobic & anaerobic waste water treatment
4. Sketch diagram showing bioscruber
5. Precautions that should be taken in dealing with compressed gases cylinders.

D) I -Mark T or F:
1. For reactions involving corrosive materials stainless steel is used for construction of the
reactor.
2. HEPA filters remove particles, vapors & gases.

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El-SaFwa Group 2016 Industry Questions
ANSWERS:
A)
2- The sketch in the (pharmaceutical process engineering) + the table in the (Industry profile).
5- a. the explosivity of some drug substances and excipient &The high duct level and energies
associated with milling operations
b. to protect the workers from spills leaks and fugitive emission.
c. to decrease temperature exposure and to enhance the removal of the unwanted
byproduct.
d. because of the difficulty in separation by the force of gravity If liquid phases ere close in density.
e. To transfer distance of slurry to avoid pipeline plugging problems & to avoid breaking of the
solid crystals.
6-discuss Wet granulation or Direct compression or Slugging.

E) I-mark T or F

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1. F hastelloy
2. F particles only

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Previous Exam
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1. write short notes on
a
1) Drug development & its different phases
2) Top 5 pharmaceutical companies in 2006, comment on them
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3) Protection against generic competition with examples


4) Different between unit process & unit operation
5) Why need for GMP
6) ISO 9000
7) ISO 14000
8) Evaporation & Crystallization
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9) Mixing & granulation


10) Items of GMP

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El-SaFwa Group 2016 Industry Questions
Environmental biotechnology
Write short notes on:
- UASB
- Activated sludge system
- BOD5
- Biofilter
- Bio scrubber
- Biodegradation of Xenobiotics
- Treatment of solid wastes
- Types of anaerobic bacteria
Compare between:
- Aerobic & anaerobic waste water ttt
- Aerobic & anaerobic composting

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- Advantages of UASB & activated sludge system
Complete the following:

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- anaerobic bacteria do not easily scavenge BOD compounds at less than(50 mg L-

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1)while aerobic bacteria can easily lower BOD under..(10 mg L-1)
BOD5 estimates the amount of ... (O2) used by.[aerobic ) microorganisms to
oxidize biodegradable organic material as determined in polluted waste-waters over a
fixed period of time.(normally 5 days), at constant temperature..(20c). If
is used as a .. (Parameter to quantify the concentration of biodegradable organic
matter present in waste-water).
a
- Trickle filters is-used-to-overcome the disadvantage of. (production-of-Xss sludge
in activated sludge system) as it production of sludge by..( forming a film of m.o.
on a carrier)
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- . (Acetoaenic bacteria) degrade fatty acids into acetate and (H2)


- Biofilters could be used for the removal of and , while
bioscrubbers are used for removal of
-
T&F
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- Anaerobic digesters are used for stabilization of sludges and low strength industrial wastes
- BOD 5 is the amount of oxygen used by bacteria to oxidize organics over a fixed period of
time.
- The biggest drawback of activated sludge system is excess sludge production.
- Biofilters are suited for the removal of hydrocarbons
- Hydrolytic bacteria inside UASB reactor cleavage fatty acids into acetate & hydrogen
- Anerobic production of biogas is a sequential stepwise process
- Aerobic composting consumes energy while anaerobic one produces energy
- Biofilters & bioscurbbers can be used to get rid of SO2, H2S &NO2
(F) Correction: used for VOCs only

Environmental Considerations

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El-SaFwa Group 2016 Industry Questions
Complete the following:

Thermal Oxidizers Use temperature (650 0C -820 oC) to convert the organic maters into ......... &
............ (water and carbon dioxide.)

Scrubbers or Gas absorbers depends on the use of. ........ (Liquid solvent) in which the compound to
be removed have high solubility

Condensation converts gaseous air contaminants to a liquid by either.... . . . . . . ... . ( temperature)


or by........ ( pressure)

hazardous waste liquids must also be stored in areas capable of containing a ................or
..............(spill of the largest container or 10% of total storage capacity), whichever is greater.

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Many elements of municipal waste can be ..............[segregated for recycling). thus reducing, disposal
costs

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Waste-waters when discharged must have maximum DO levels and ..... . . . . . . . . (minimum oxygen

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demand compounds) SO that DO levels remain above .. .. " .(5 mg/L).

Pharmaceutical manufacturing facility discharging to must participate in pretreatment


program which include .., .., and..

Give short account on :


a
Facility design considerations for waste-water management
Waste-water characteristics
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Factors to be considered when selecting air pollution control equipment

Choose the most appropriate Answer

1. Hazardous waste gas levels are kept minimum with the aid of
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A. Bioscrobbcrs
B. Biofilters
C. Gas absorbers
D. All of them.

2. Legislation concerned with regulation of potential environmental requirements are developed by


A. EPA
B. Congress
C.WHO
D. FDA.

3. In order to control air emissions into the atmosphere


A. EPA has developed standard tables indicating expected pollutant to be emitted, emission levels, and
monitoring requirements for a specific source.
B. Trickle filter may be useful aid
C. Air pollution regulatory equipments must be utilized

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El-SaFwa Group 2016 Industry Questions
D. Both a & c.

4. Air emissions are classified


A. Considering their physical state
B. According to their effect on human life
C. into hazardous air pollutants & criteria pollutants
D. All of them

5. Air pollutants that are organic in nature could be considered as


A. Common air pollutants
B. Hazardous air pollutants
C. Both a & b
D. Neither a nor b

6. Selection an environmental friendly air pollution control equipment


A. Scrubbers are considered the best.
B. Thermal combustors are considered the best
C. Bioscrubbers are considered the best

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D. Both b & c

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7. Environmental protection agency regulates environmental requirements in accordance with.
A. CAA
B. CWA
C. RCRA
D. All of them 20
8. Anaerobic digesters are more advantageous compared to aerobic ones in term of
A. Small sludge production
a
B. Energy balance,
C. Both a & b
D. None of then
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9. Absorbers are disadvantageous in regard to


A. Continuous regeneration of the adsorbent is required to maintain the efficacy of the equipment
B. Generation of a secondary environmental pollutant
C. Less expensive to install than other air pollutant control equipment.
D. Both a & b.

10. Surface water quality way be affected by


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A. Water resulting from spills, leak, and product


B. Falling rain and snows
C. Both a & b
D. None the above.

11. ........... May be used for the removal of inorganic air pollutants
A. Thermal oxidizers
B. Bioscrubbers
C. scrubber and condenser
D. None of them

12. All of the following is true except


A. Biofilter are used to remove acid gases from gas exhaust before discharged to atmosphere
B. Thermal oxidizer converts VOCs into CO, and H2O
C. selected air pollution control equipment must ensure that emission limits are in compliance with
regulatory levels

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El-SaFwa Group 2016 Industry Questions
13. Encircle the incorrect statement
A. waste water must have minimum oxidizable organics when discharge into surface water
B. Precipitation of carbonates occur when water PH exceed 9
C. PH of waste water should not exceed 6
D. Presence of biodegradable organics especially low molecular weight water soluble represent the most
serious problem associated with waste water.

14. Primary treatment of waste water Involves


A. Removal of coarse solids and heavy particles that cause plugging of pumps and damage of downstream
equipments.
B. Removal of oils and fats from waste water
C. Removal of dissolved or finely divided organics by biological means
D. Both A & B

Safety measures
Make T or F and correct the false:

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1- fire wall cutoff provided where floor areas are large are considered vertical cutoffs
2- When gas concentration exceeds 2% in air. or oxygen concentration is less than 16%, gas mask

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canister type (universal type) can be used.

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3- In safety and fire protection measures, orange color indicate caution while yellow indicate fire
protection equipment.
4- We should always use the valve cover or cap to lift cylinders in order to avoid dropping.
5- Never to store cylinders in upright position so that they do not explode.
6- Full cylinders should have a ring put over the safety cap to mark if from empty one.
7-airpurfying respirators remove airborne contaminants as particulates and gases, EX. Gas mask
a
canister type
8- in Class A fires blanketing effect of extinguishing agent is of greatest importance
9- CO2 fire extinguishers act by blanketing effect so can be used in class B fires.
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Complete:

1- Black &white combinations color codes indicate while green indicate ..


2- Precautions taken in dealing with compressed gases cylinders include................................
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And....................
3- (PPE) should not be transferred from one employee to another unless it is........
4- (SCBA) supply air from a source that is.............. while (SARs) supply air from a source
5- White canister protects against ............ blue canister protects against . ........ While.......... canister
protects against hydrocyanic acid.
6- Automatic sprinkler systems react to fire without the need for human intervention as
heat from fire cause either....................... Or........ ................
7- Fires that involve energized electrical equipments are considered class fires where............
property of extinguishing agent is of primary importance.
8- Class C fire extinguishers fight ......... fires, while class D fight................ Fires.
9- Dry powder fire extinguishers generate has ...... & ...... effect
10- Fire protection in factories include ............, ......... .& ....... . ..... .....
11- The distance to be maintained between buildings depends on .......... and .
12- Standard safety colour code can be used for safety purposes, for example

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El-SaFwa Group 2016 Industry Questions
a. Red ..
b. Orange
c. Green ..
d. Yellow
13- Proper ventilation inside pharmaceutical plant building can be accomplished by:
a.
b. .
14- Horizontal cutoffs should be of , with all .
15- Dry powder fire extinguishers exert a threefold action:
a.
b.
c.

Compare between:

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- Air purifying respirators & atmosphere supplying respirator
- Standard safety color codes used in buildings & canister color codes (using red, yellow & green

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colors as points of comparison).

ANSWERS T or F:
1-X horizontal cutoffs
2-X use atmosphere-supplying respire for;
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- Different classes of fires, and choose one of the following fire extinguishers: Wafer, dry powders &
CO2 to extinguish each class

3-X orange: dangerous parts of machines, yellow: caution.


a
4-X do not use valve or cap to lift cylinders
5-X store them upright
6-X empty cylinders should have a ring
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7-T (C.F. HEPA filters and carbon filters in isolator)


8-X class B
9-T
Complete:
1- Traffic, safely
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2- Provide durable labels. Do not use the valve cover cap to lift cylinders. Full cylinders should be
stored apart from empty one, Regulators and pressure gauge provided for use for particular gas
must not be used on cylinder containing other gases.
3- Sterilized
4- Carried by user, located some distance away and connected to the user by hose
5- Acid vapors. Organic vapors, White with green strip.
6- Burst of fast responding bulb, melting of easy melt alloy
7- C, non conducting
8- Electrical, burning metal
9- CO2 , cooling . blanketing effect
10- Fire. alarm equipments, Automatic sprinkle systems, First-aid fire extinguishers
11- The type of construction, the area and height, hazards of the processes, the land available for
present and future expansion.

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El-SaFwa Group 2016 Industry Questions
Comparisons: a-
air-purifying respirators (gas masks): Atmosphere supplying respirators
-remove particulates & gases from air by filtration, I-Self-Contained
absorption, adsorption, or chemical reactions. Breathing Apparatus
l-Gas mask canister type used when: (SCBA):
1- Gas conc. Not exceeding 2% supply air from a source carried
2- nature of gas is known by the user (used by firefighters
3- Sufficient air supply is available. and divers).
Il-Gas mask canister type (universal type):used when: ll- Supplied -Air Respirators
1- Gases cone, not Exceeding 2%. (SARs)=(air-line respirators):
2- Unknown gas (used for protection against all gases Supply air from a source
including carbon monoxide). located some distance away and
3- Oxygen concentration is 1 6% or more. connected to the user by an air-
tine hose.

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b-

buildings
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standard safety color codes used in

- Danger, stops and fire protection


Canister color codes

Universal (for protection against


RED Combination of acid gases, organic
equipment.
vapors, ammonia and smoke)
a
YELLOW Caution. Acids, organic vapors
GREEN Safety and the location of first aid -Ammonia
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equipment.
c- Water for class A , CO2 for class B dry powders for class C
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El-SaFwa Group 2016 Industry Questions

Sterile area questions


Complete:
1. Functional areas involved in the manufacture of sterile products include and, they
must be ..to prevent cross contamination.
2. Microbial sampling of the air (suspended in air)= (passive air) can be done by and
.while Rodac plates are used for.
3. Preparation of solutions in terminally sterilized products occur in grade .environment
while, preparation of solutions to be filtered occur in grade ..environment.
4. Aseptic preparation occurs in grade .environment while, preparation of solutions to be
filtered occurs in grade environment.
5. .test efficiency of an aseptic felling process.
6. Products are that at high risk during preparation include.and while filling process may
be at high risk if or
7. Clean area: a room with defined environmental control designed to ..contamination of

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product while aseptic area is a special area designed to microbial contamination of
the product.

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8. In the sterile area , HVAC is designed to .,.and to control :..,..&..
9. HVAC designed considerations include ..the amount of outside air.
10.
11.
12.
HEPA is abbreviation of .
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Critical defects in inspection of ampoules include , ,..
In the occupancy of clean room, as built means .

Put T or F
a
1. The pressure differentials in the change rooms shall be in the descending order from white to
black.
2. Microbial surface sampling can be done by slit-to-agar (STA) sampler.
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3. Microbial deposition onto surface can be done by stele plate sampling which is a simple.
Inexpensive, quantitive test.
4. As built state means installation is complete but with no production equipment, materials or
personal present while at rest state means installation is complete with equipment installed
but not operating and with no personal present.
5. Sterilely assurance of 106 or better should be demonstrated for any terminal sterilization
process.
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6. Sterility assurance of 106 means there is no any non-sterile container in a 1.000.000 batch.
7. HEPA filters are disposal, extended media dry type filters in a rigid frame, a maximum
practice penetration of 0.03% for 0.3 um particles of thermally generated DOP (dioctyl
phthalate) or hydrocarbon Emory 3004 aerosol.
8. In the sterile area the ceiling, walls, and floor must be sealed and without cove to be easily
washed.
9. In laminar flow enclosures: air is delivered through HEPA filters occupying all the walls&
ceiling.
Answer the following questions:
1. Describe a technology in which the container's is formed, aseptically filled, and sealed in the
same machine, state the room class required, and advantage of this technology.
2. compare between :
a. EC& FDA classifications of sterile area.

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El-SaFwa Group 2016 Industry Questions
b. Examples of terminal sterilization & aseptic processing operations to be carried out in
different classes of clean rooms.
c. Gowning in different classes of clean rooms.
3. Define: air lock, laminar flow enclosures.
4. Write short notes on
a. Examples of operations to be carried out in the various grades of clean room for
terminally sterilized products
b. Advantage of blow/fill/seal technology over aseptic filling
c. Particle counting in different occupancy states
d. Parenteral product flow plan
Answers

Complete:
1. warehousing, compounding , filling and packaging separated
2. slit-to-agar (STA) sampler, centrifuge sampler microbial surface sampling .

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3. C.D
4. A,C
5. MEDIA fill (PROCESS SIMULATION TESTING)

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6. Product supports microbial growth, product held for a long period before sterilization and

7. reduce , prevent 20
product processed in open vessels, filling operation is slow or the containers are wide-necked
or are exposed for more than a few seconds before sealing.

8. Minimize introduction of particles from external source, minimize retention of particles


temperature, relative humidity, room pressurization.
9. minimizing
Put T or F
a
1. T
2. x rodac plates
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3. x non- quantitive
4. x equip . operating
5. x one non- sterile container
6. x 10-6
7. T
8. provided with a cove
9. x one entire side of the confined space.
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Pharmaceutical packaging
Complete

1. .relates to the ease with which one material will slide over another whileis tendency of
two adjacent layers of film to stick together.
2. resistance to the development of pin holing and when subjected to repeated flexing
3. ..users gravity or centrifugal force to cause molten glass to form in the cavity of the mold.
4. is a threaded screw cap with an interrupted thread , instead of a continuous thread, so
requires
5. A security hologram is present on the packaging of ..And .for protection against.
6. .solutions permanently stain many polyolefin compounds after brief exposures, due to
.of polyolefin.
7. Types of glass include type..or borosilicate glass where the addition of 6% boron reduces the
..actions, while type or treated soda-lime glass more

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El-SaFwa Group 2016 Industry Questions
8. .indicated the degree of distortion of an object seen through the film , while is a
measure of milkiness caused by light scattering by surface imperfections.
9. Laminate squeeze tubes offer the advantage of plastic E.Xbarrier properties of &the
strength of layers, sealing the edges of the lamination together occur in a machine called
..E.X of lamination squeeze tubes is
Put T or F
1. Pilfer proof closures is pressed, twisted for entry.
2. Primary packaging includes ampoules, vials, bottles, closures, blister, packaging measuring
spoons and dosing cups.
3. Tensile strength is a measure of the ability to withstand shock.
4. Higher density plastics will produce more molding per unit weight.
5. We should always start by using materials with the highest possible barrier (e.g. Aclar) as a
packaging material.
6. Threaded screw caps, lug caps, rubber stoppers are used in making tamper resistant.
7. migration of dyes from plastic into parental solution causing toxicity is called sorption
Compare between each of the following:

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1. Thermoplastics & thermostat giving one example (and one application of the example) on

1
each.
2. Blister thermoforming plastic film & lading.
3. Metal & plastic collapsible tubes.
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How properties of glass are affected by the kind of elements it contains?
Write short notes on
a. Blister packaging & higher protection in blister packaging
b. Packaging as an attributes in packaging suitability
a
c. Various types of glass
Answer
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Complete

1. coefficient of friction or slip , blocking


2. flex resistance
3. casting
4. Lug caps, only a quarter turn.
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5. Viagra , Zantac
6. iodine , chemical reactivity
7. Type I, leaching, Type II , weathering , chemically resistant .
8. clarify , Haze
9. Heat sealabilty, metal (al foil) . Paper. Sideseamer , toothpastes
T or F
1. X child resistance cap
2. X not include measuring spoons dosing, cups
3. X impact strength
4. X lower density
5. X
6. X pilfer proof closures
7. X leaching
Comparisons:

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El-SaFwa Group 2016 Industry Questions
1. Urea formaldehyde (thermoset) used in closures of collapsible tubes PVC (thermoplastic)
used in blister packaging.

Material for plant construction


Complete
Copper alloy may be . (brass and bronze)
Nickel alloy may be (monel and inconel)
Aluminum container safely used for storage .. (of acids and alkalines)
Brass is mainly used for . (tube plates of evaporator) . while bronze is used for .. (autoclaves,
high pressure pipes, pumps and tablet bunches and dies).
Inconel mainly used for . . . . . . . . . . ..... .
Stainless steel is the .. (ideal metal for construction of pharmaceutical plant).

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Physical factors affecting the material selection are
1-strength of material 2-weight of apparatus
3-wearing quality 4-ease of fabrication

1
5-thermal conductivity 6-thermal expansion (to avoid fracture by heat)
7-cleanlng (easily cleaned) 8-transparency, so we may use borosilicate glass
9-sterilization. 10-economic factor
write short notes on :
1 . Different types of alloys
2. Copper and nickel alloy
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Pharmaceutical industry profile questions
A. explains briefly each of the following:
a
1. How can branded companies protect their branded products generic competition?
2. You are the manger of a multinational company , and there is an offer from another
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company to merge with yours, would you accept that offer and WHY
3. Pharmaceutical companies are pooling their resources to compete more effectively .. HOW?
4. Future expectations of pharmaceutical industry.
5. The Egyptian market development from the beginning till now.
6. Brands vs generic companies.
B. Enumerates:
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1. different phases of drug development


C. Rationalizes:
1. Sanofi acquired Aventis to form Sanofi Aventis
2. Increase in investment R and D has not been matched by a comparable increase in new drug
approval in USA.
3. The demand for vaccines is difficult to forecast.
4. Exports have declined in recent years in Egypt
5. Previously a pharmaceutical company had only small percent of market share?
6. generic competitions usually cause large fall in prices
D. Complete:
1. is the growing trend within the Egyptian healthcare industry as a result of declining
standard of public sector care.

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El-SaFwa Group 2016 Industry Questions
2. Market competition depends on .and
3. Pharmaceutical manufacturing facilities must meet two objectives & .to marketing
and regulatory forces.
4. The development of a drug costs up to .and requires..to be introduced into the market.
5. Market competition depends on .and ..
6. the largest pharmaceutical markets are ..,.&

7. ranking of Aventis was ..... in 2003. then ..... .in 2006 due to.........with ......

8. .........Is the multiplication of the number of all the issued shares with the exchange rate at a specific
time.
9. Global Public-Private Initiatives (GPPI) parts: It is a measure of the participation degree of
each company in healthcare problems in the.......... .
10. .. drugs that have sales> 1 billion US$ I year.
11. developing of pharmaceutical companies (like; Merck. Bayer, Schering) in Europe: in the .... . . . . . .
century with advances in . . . . .

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E. T or F

1
Future expectations of pharmaceutical industry include more consolidations,
increasing use of prescription on medicines, use of tax favored regions for

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manufacturing high value products to gain maximum benefits.
branded companies are companies that branded drugs only
success rate in phase III clinical trials> in phase 1
Pharmaceutical industry is multicompanies , multiproduct for human health
Merck Bayer and Schering pharmaceutical companies originated from USA
lndustrial pharmacy is the science & technology of production of drugs
a
Japan pharmaceutical market is considered as third global consumers market place
Advance in organic chemistry leads to large scale chemical operation.
pharmaceutical market share is concentrated in fewer, larger global enterprises.
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some innovative company developed & product origin version & generic drug.
Marketing is one method to reduce generic competition .
the development of new vaccines takes 7-1 2 years in private companies .
ACTOS IS BLOCKBUSTER DRUG OF BRISTOL-Myers Squibb .
IN FRANCE THE MARKETSHARE OF GENERIC PRODUCT IS 60%.
cost of future facilities will rise in response to complicated technologies.
phase 2 in drug development least safety dosage & side effect.
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core businesses is a new trend in pharmaceutical companies.


the mission of pharmaceutical industry is to perform & conform
cost effectiveness is seeking to overcome drug consumer cost & health care.
in USA the competition of brand product begin after the expiration of the parent.
Development of new drug includes research phase & patent protection for 20 years.
Reform programme of Egyptian pharmaceutical companies is start in 1990s.
marketing & distribution leads to global pharmaceutical industry
R&D expenditure leads to increase sales of product.
Answer

A:

1. protection against generic competition


2. YES, state advantage of consolidation
3. Adv. Of consolidations
B:

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El-SaFwa Group 2016 Industry Questions
1. drug passes through the following phases :
the research phase
the development phase
the approval phase
Then you must state the table of phase 1, phase 2 .

C:

1. state advantages of consolidation


2. Due to the application of stricter regulations in USA by the FDA: reasons for not approving
a drug are negative by-effects that were identified in clinical trails and the limited added
value.
3. because :
1. It may change according to the severity of diseases, production lead time,
regulations.
2. Actions of competitors during the vaccine production cycle , which is longer than
the production cycle of pharmaceutical .

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4. because of The rising costs for imported raw materials, due to currency depreciation which
decreased the local production.
5. Recently: mergers and consolidations have focused the economic power in few multi-notional

1
companies

D:

1.
2.
privatization
new therapeutic indications and economic value
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6. generic producers do not have to make high R&D investments

3. to perform and conform


a
4. 400 million US$ , 10 years
5. new therapeutic indications , economic value
6. USA Europe and Japan.
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7. 10th , 3 rd , consolidation, sanofi-synthelabo


8. The market value (market capitalization)
9. developing countries
10. blockbusters
11. late 19th, organic chemistry
E:

T
Sa

-
- X also produce generic
- T

Pharmaceutical Process Engineering question


True or false
1. Unit process deals with the chemical reactions in industrial operations.
2. Boiling up with organic solvents Is used to clean the reactor.
3. Optimal crystal growth obtained by agitation .
15. API processing require 3 10 steps for preparation
16. Research laboratories include synthesis, microbiology and histology.
17.API reactor are heated by internal heat transfer coils.

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El-SaFwa Group 2016 Industry Questions
18. the surface of weighing area should be slightly smooth and sealed
38. unit operation include hydrolysis, condensation, drying, size reduction 8 oxidation.
21. Air swept mills use the carrier gas to decrease particle size .
34.extraction is the transfer of material from one liquid to another miscible liquid .
35.distillation is used to recover 8 purify solvents.
36.solidification is obtained by heating ,evaporation of solvents
39. facilities must be designed to prevent cross contamination.

Explain briefly each of the following:


1. Unit process & Unit operation (giving examples).
2. Steps of manufacturing of API, state the type of each step (unit process or unit operation),
discuss
3. Crystallization process.
4. Drying process.
5. Size reduction process.

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Sketch each of the following:

1
- Drug development in pharmaceutical industry.
-

1. the table
20
Fermentation process in pharmaceutical industry.

Answer

2. Raw materials reacted (the only unit process, the rest are unit operations)
solidified separated from the solvent by filtration dried milled to reduce
a
its particle size. (Explain any two: E.X. crystallization, filtration)
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GMP
T or F
4. GMP rules are the most important factor during manufacture..
5. Failure to comply with cGMP subjects the person to regulatory action
20. QA is a part of GMP
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22. Quality must be built into the product from manufacturer to consumer.
40.GMP is a set of regulation required to improve drug.
41. premises is must be prevent & designed to prevent mix up.
42. cleaning requirement appear in 1987 version of GMP.
43. storage arrangement is effectively employed by persons.
57. GMP concept concern with manufacture & QC

ISO
Complete the following:
1- Quality manuals can be used as or..
2- ISO 9003: The contractual standard for companies that..and products
designed and manufactured elsewhere.

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El-SaFwa Group 2016 Industry Questions
3- The framework identifies .. Requirements, each of which affect quality. Each
requirement is identified in the.
4- .is the highest level of documentation of an ISO 9000 quality system
5- Most standards require periodic revision, this is due to..or.
6- ISO was developed in 1946 in order to
7- All ISO. Standards should be reviewed, at intervals of not more than . Years or
sometimes earlier
8- ISO 14698 consists of 2 parts which are . &
9- The first document of ISO 14644 was entitled .
10- ISO 14644 consists of . Parts while 14698 consists of .. parts
11- ISO was first established .. (in 1946 in Geneva) to develop standardization in the world
12- ISO standards were based on the British standards . (BS-5750) published in . (1987)
Give short account on the following:
- Forms of audit of companies
- Aims of ISO

7
-EMS
-ISO 9000 standards

1
- second party audits
- Quality manual
- Quality System
T or F
-
20
Large companies are pressurized by small customers to implement ISO 9000 and achieve
certification lo demonstrate that their quality system conforms to one of the standards in
the series. F
a
- ISO 9000 compliance alone is not enough to choose one supplier over another F
- IS0 standard require periodic revision.
Fw

- ISO is work wide governmental organization started in Geneva 1946


- IS0 9002 deal with companies manufactured , but does not design what they manufacture
- IS0 14698 considered clean rooms and associated environment control.
- the second part audits carried out by organization own staff
Sa

Facility planning
Give short account on:
1- business case far facility planning
2- keys for successful senior management-level presentations
3- The First Pass at Project Scope
4- communication during facility planning
5- Surveillance systems

16
El-SaFwa Group 2016 Industry Questions
6- business development organizations
7- How do States create incentives to attract companies?
8- outsourcing & acquisition
9- Reasons to plan a facility
10- importance of facility planning

Sketch a diagram showing:

1. Developing a facility project from a business case


2. Developing scope from a facility project plan
3. Developing a senior-management level presentation from project scope
4. Renovation costs relative to age of facility
5. The First Pass at Project Scope

Complete the following:

1 7
1 - The two biggest variables in facility planning are .(the predicted product
approval time, its selling potential).

20
2- Creating.. (Scenarios) that consider the relationship between time and money is
a good planning tool in (what if)
3-Tax zones / incentives usually affect building secondary facilities for the products that are
more. (Easily transferable)
4-Early sharing of the project is essential to project approval. This process is called
. (Dusting)
a
5-Tne most advantageous tax zones for pharmaceutical and biotechnology development
and manufacturing, are..(Ireland, Puerto RICO and Singapore). They have
Tax advantage...... (as low as 2%).
Fw

6-Providing a safe and secure work environment requires (1-physical security


measures 2- administrative corrals 3-personal ownership)
7-Parking lots should be least (100 feet) from nearest building.
8- Entrances should be. (100 feet) from roadway
9- When the formal management presentation is made, the project should be a (Fait accompli)
Sa

17