MULTIPLE CHOICE ASSIGNMENT b.

Board of Directors
Industrial Pharmacy Course [Link] of Production and Head
Quality Assurance section.
1. Complaints about pharmaceutical products are divided d. Marketing Manager and Marketing
becoming two, namely Pharmaceutical Technical e. Human Resource Development Manager
Complaint and Pharmacological Complaint.
Among the following
is example 5. A number of drugs that have properties and m
pharmaceutical technical complaint the uniform heat produced in one
except.... the creation cycle of a command
a. The absence of brochures and packaging that A certain dimension is an explanation of what?
damage from Ambroxol syrup. A. Medicine becomes
b. Change of color of the solution in Injection B. Household products
Carbazochrome. C. Lot
The scarcity of Bisoprolol tablets is due to D. Bets
the disruption of the distribution process. E. Product between
d. Sitaxentan was withdrawn from the market because
has the risk of hepatotoxicity. 6. If there are significant changes to the ...
e. Ibuprofen suspension that experiences adapt equipment, systems, facilities, processes,
decrease in levels. cleaning procedure, and analysis methods,
so it must be done….
2. What is meant by raw materials a. Requalification
medicine.... Re-validation
a. Materials in the form of vaccines, as well as (antisera) c. Evaluation
and biological materials. d. Error analysis
b. All materials/components are in the form of elements, e. Change control
single compound, and/or mixture
which is in solid, liquid, or gas form 7. In the process of a drug in an industry
c. Materials that originates from pharmacy needs to avoid actions that
natural resources causes cross-contamination
d. All materials are in the form of elements namely except:
originating from diagnostic materials
a. The availability of air cushion space and
e. All true
air sucker
b. Production is carried out inside the building
3. Industry Pharmacy that produces
various products in large quantities, as well as separate except for products like penicillin,
sex hormones and other preparations that
marketed in pharmacies, hospitals, stores
Medicine, Supermarket, etc. Organization contains live bacteria
c. To reduce air risk that
the suitable marketing is....
recycling
A. Matrix Organization
B. Product Management Organization d. High-risk individuals wear
appropriate protective clothing
C. Functional Organization
D. Market Management Organization e. Using self contained
E. Product Management Organization and
Market 8. Each material or mixture of materials that
still requires one or more stages
The pharmaceutical industry is responsible for advanced processing to become a product
providing qualified personnel ruahan, is part of....
in adequate amounts for a. Household products
carrying out all tasks. Key personnel b. Intermediate products
in the pharmaceutical industry includes: c. Finished product
a. Chief Executive Officer
 d. Primary packaging 13. Returned goods that
e. Secondary packaging returned to the industry, among others?
a. Product expired date
9. In the industry to know whether b. Finished product
the analysis we have done has been validated. Therefore c. Quarantine products
validation method needs to be performed with d. Evaluation products
comparative or other analysis methods. e. Test products
The method includes:
A. Identification test, stability test, and test 14. What is the purpose of packaging?
purity a second is....
B. Strength test, uniformity test and test a. Enhancing product identity security
stability b. Reducing the selling price of the product
C. Qualitative and quantitative tests c. Raising the selling price of the product
D. Test levels, qualitative and quantitative tests d. a and b are correct
Identification test, purity test and test e.a and c are correct
rate
15. The processing of cefotaxime injectable powder
10. The following is a part of purified water that conducted in the classroom....
is a technique for producing pure water a. Grey area
(purified water) that can lower b. Black area
up to 95% TDS in water, which is.... Classroom A
d. Classroom C
a. Loop system e. Classroom D
b. Water Softener Filter
c. Electronic De-Ionization 16. Below is the Hierarchy Structure
d. Reverse Osmosis Documentation, except....
e. Multimedia filter a. Quality manual
b. Standards
c. Procedures
11. Here is an example of a disability in d. Form & Records
critical pharmaceutical industry, except: e. Inspection
a. Incorrect marking
17. The process of completing and documenting
b. Cross-contamination of materials or
product study design to ensure that
c. Pollution of pure water or water for all aspects of quality have been considered
injection and reviewed at the planning stage including
d. The main equipment is not calibrated or in the validation stage?
out of calibration range a. Installation Qualification
e. Production is carried out according to procedures b. Operational Qualification
that has not been approved c. Process Qualification
[Link]
12. Handling complaints is a task and e. Retrospective Validation
responsibility of the section....
18. The following is not
a. Production inspection conducted by Quality
b. Quality assurance Control (QC) is....
c. Quality control a. Inspection of semi-finished products and
d. Validation stability
e. R & D b. Microbiological examination
c. Examination of facilities and infrastructure
d. Inspection of raw materials
 e. Inspection of packaging materials 24. Validation is an action
proof in an appropriate manner that
19. The hierarchy of document structures is found in each material, process, procedure, activity,
which arrangement of objectives and commitments system, equipment, or mechanism
in product quality? used in production and
a. Standard supervision always achieves results that
b. Procedure desired. Validation consists of several
c. Manual quality part, one of which is method validation
d. Form of notes analysis that must meet several
e. cGMP parameter. If the analysis method that
done does not have resilience that
20. Below are the tasks and responsibilities If modifications are made, then
answer the Quality Control section, except.... the method does not meet the parameters
a. Sampling :
b. Testing a. Precision
c. Specification [Link]
d. Inspection c. Repeatability
e. Investigation d. Accuracy
e. LOD
21. The master production document is a document
which describes the qualitative composition and 25. The process of making the solution that will
the quantity of a product, the method of production, filtration sterilization must be
recommended equipment and conducted in the environment....
history of product formula development a. Class A
usually compiled by... b. Class B
a. Production unit c. Class C
b. Quality control d. Class D
c.R & D Class E
d. Quality assurance
e. QC 26. In the processing of Purified water system
consists of one tool that functions
22. Below are some parameters to eliminate and/or reduce
critical from a granulation process unit water hardness by binding ions
except? Ca++ and Mg++ that cause
a. Bet size the high level of water hardness is...
b. Stirring speed A. Multimedia filter
c. Granulation processing time B. Active carbon filter
d. Density of material/substance [Link] softener filter
e. Granulation volume D. Reverse Osmosis
E. EDI (Electronic De-Ionization)
23. Having duties and responsibilities in
sampling, testing, specifications, inspection, and 27. A pharmaceutical industry produces
monitoring (STSI-M) is a task and tetrahydrozoline HCl eye drops.
responsibility of ? In its production, it is done in class.
a. R&D certainly. In which class is the production
b. QA done?
c. Manager Class A+E
d. QC (answer) Class A+D
e. Pharmaceutical plant technician c) Class A+B
d) Class D+E
e) Class C+D
 a. Weighing of raw materials for sterile products
28. There are several levels of materials or b. Non-sterile product production
products before reaching the product that c. Secondary packaging of non-sterile products
ready for marketing. One of them is the material d. Primary packaging of sterile products
or a mixture of materials that are still e. Production of aseptic products
requires one or more levels
advanced processing to become a product 33. The air management section that regulates pressure
next, it is called.... is....
A. Raw materials a. Ducting
B. Packaging materials b. Blower
C. Intermediate product c. Filter
D. Household products d. Dumper
E. Finished products e. Heating

29. A pharmaceutical industry will make 34. Table saved retained sample
eye ointment product, suitable room Quality Control laboratory is....
used for the production process of preparations One year after the expiration date
that is... product
b. Six months after the expiration date
[Link] area, class A product
b. grey area, class E c. Two years after the expiration date
c. black area, class F product
d. white area, class C One and a half months after the period
e. grey area, class D product expiration
30. Date of raw material delivery to the warehouse Three months after the expiration date
is as follows: product
Container I contains: 1000 sacks
35. In Good Manufacturing Practices (CPOB), the materials used
Container II contains: 1000 sacks
in the preparation of pharmaceutical formulations must be
Container III contains: 1600 sacks
So the number of sacks that must be taken good and of quality. There are several
for a sampling of... levels of material or product before
to achieve a product that is ready for
a.51 sack
b.56 sack marketed. One of them is the material or
c.60 sack a mixture of ingredients that still needs
d.61 sack one or more stages of further processing
e.66 sack to become the next product which is
called....
31. Material that has been processed and is remaining a. Raw material
b. Packaging materials
requires packaging activities for
c. Intermediate product
becoming a finished medicine is called...
d. Household products
a. Final product
e. Finished product
b. Intermediate product
c. Bulk Production
d. Semi-finished products 36. Handling or procedures that must be
e. Household products to be done if there is a product return,
except:
32. A room with grey classroom area a. Detention
having a maximum number of particles b. Discarded products (answer)
size ≥ 0.5 µm that is allowed c. Recycled or destroyed
3,520,000/m3found in the space... d. Research
e. Retesting the product
37. Testing or testing is b. Avoiding Drug Damage
responsibility of the Quality section c. Ensuring the implementation of processing
Control in an industry. Testing medicine in accordance with regulations
for sterile injection preparations can be done d. Have knowledge, skills
in the room... and ability
a. White area (class A) e. Providing adequate protection
b. White area (class C) regarding the distributed medication
c. Grey area
d. Black area 42. Validation is the process of proof.
e. Where else that a procedure, raw materials, etc.
according to what we expect in
38. Special products that are processed with achieving goals. The following is
using special equipment, namely, one example of proper validation,
except.... that is....
Beta-lactam
[Link] a. Speed complaint in
mixing the base with the active substance
c. Hormone
d. Cytotoxic in making ointment
b. Temperature in dissolving an active substance
e. Biology
c. Time complaint in
mixing the base with the active substance
39. In a Pharmaceutical Industry, the QC organization in making cream
consists of a raw material testing laboratory, d. Speed complaint in
finished product testing, product testing making a suspension
e. The temperature at the time of mixing water phases and
among others, etc. The form of the organization is
based on.... oil phase in making emulsions
a. Production process 43. how to avoid pollution
b. Testing/Analysis Process except:
c. The urgency of testing
d. Method/equipment a. Wearing appropriate protective clothing
e. The material being tested in the product area.
b. Using a self-contained system
40. Standard air used in the industry c. The availability of buffer space and
having different levels, air sucker
used for water production or d. Production in separate buildings
What is tablet manufacturing? e. The production of goods is consolidated within
a. Grade II: Purified Water the same space
b. Grade II: Potable Water
44. In complaints based on level
c. Grade IV: Water For Injection
risk, complaints about the product that
Grade III: Purified Water
does not impact the quality of the product
Grade III: Water For Injection
that is?
41. Good Distribution Practice for Medicines A. Major
B. Critical
applied to ensure the quality of drugs
C. Quality complaint
throughout the distribution process. Aspect
D. Minor
Important in CDOB (Distribution Method
E. Commercial complaint
Good Medicine) is a Procedure
Solid operations are carried out
45. QC is the department that is led by
with the aim of....
by a pharmacist to carry out
a. Monitoring fulfillment against
quality control. The following is
rules and standards established
 the inspection carried out by QC, c. cleanliness of neat packaging
except: d. the tablet is fully charged
a. Raw material inspection e. calibration of tools
b. Inspection of semi-finished products
c. Finished product inspection 50. Complaint about the product that is not
d. Inspection of packaging materials impact on quality product
e. Microbiological examination categorized as a complaint :
a. Minor
46. Facilities, systems, equipment, and processes b. Major
including the cleaning process shall be c. Critical
evaluated periodically for confirmation d. All are correct
its validity. According to BPOM 2012, this e. All wrong
this belongs to the part....
a. Concurrent validation 51. Process proof that something
b. Retrospective validation procedure, raw materials, in accordance with the
c. Qualification of facilities, equipment and expected to achieve purpose
system is....
d. Operational qualifications a. Calibration
Revalidate b. Validation
c. Qualification
47. The main system components of the air conditioning system in d. Verification
one of the production rooms is e. Specifications
dumper, what is the function of a dumper?
a. Regulating the amount of air that enters 52. Good Manufacturing Practice (GMP)
production space aims to:
a. Facilitating production and distribution
b. Connecting the blower to the room
production b. Facilitating QC in the selection
c. Controlling temperature and humidity sampling
relative c. Reducing production costs
d. Ensuring that the medicine is made consistently
d. Controlling the number of particles and
microorganism and meet the requirements that
established and in accordance with the objectives

48. There are several levels of materials or products its usage

before reaching the product that will e. Facilitating creation preparation
safe and effective pharmaceuticals, and
marketed. One of them is the material
or a mixture of materials that are still guaranteed quality
requires one or more stages
further processing to become 53. The correct sequence in development
the formula of a pharmaceutical preparation until it can be obtained
the next product is called....
a. Packaging materials mass produced is....
b. Intermediate product a. Laboratory scale test, scale test
c. Finished product production, pilot scale testing, pre-formulation
d. Household products b. Preformulation, laboratory scale testing, testing
production scale, pilot scale testing
e. Raw material
c. Preformulation, pilot scale testing, scale testing
laboratory, production scale testing
49. The mixing and filling process must
d. Preformulation, laboratory scale testing, testing
always validated so that...
pilot scale, production scale testing
a. Attractive display
b. ensuring that the product is always in e. Production scale test, pilot scale test, test
homogeneous state laboratory scale, preformulation
54. The most accurate definition of standard operating procedure is below d. Performance, operations, design, installation
this is.... e. Operational, performance, design, installation
a. Instructions for the implementation of a
specific work well 59. If a steril product for infusion preparation must
b. Detailed written instructions for done in classroom A then
achieving the same implementation or in the final sterilization of infusion preparations
the uniform of a job function must be done in the classroom:
specific a. class C
c. Written instructions from a function b. class B
specific work c. class D&E
d. Instructions for achieving implementation d. class F
the same or uniform from a e. class G
specific job function
e. Instructions not detailed for 60. Penicillin preparation is produced with
achieving good implementation a separate AHU system because....
a. The smell is unpleasant
55. Manufacturing date b. Penicillin is a β-lactam compound
the date that indicates: c. Can cause resistance
a. Beginning of the processing process d. It can contaminate other products
b. Beginning of the weighing process e. Must causing reaction
c. Beginning of the production process great hypersensitivity like
d. Beginning of the manufacturing process anaphylaxis
e. The end of the manufacturing process
61. Head of production department and head
A drug product is suspected to be contaminated. the QA (Quality Assurance) section on
by microbes in non-sterile products, a pharmaceutical industry is led by
therefore the product must be recalled by the factory a qualified pharmacist.
that. Based on the seriousness and flaws The qualifications of the pharmacist include:
product, recall of finished medicine a. Registered and qualified
(PJKO) belongs to which class? b. Obtaining appropriate training,
a. Grade 5 c. Grade 4 c. Having practical experience that
b. Grade 1 d. Class 2 sufficient in manufacturing field
e. Grade 3 medicine and managerial skills
so as to allow for
57. The pharmaceutical industry is responsible for implementing the task in a way
providing personnel who professional
qualified in a sufficient amount d. A and C are correct
to carry out all tasks. Personnel A, B, and C are correct
Keys in the pharmaceutical industry include:
a. President Director 62. Inside the CPOB the materials that
b. Board of Directors used in pharmaceutical preparations must be
c. Head of Production and Head good and quality. There are several
Quality Assurance section the level of material or product before
d. Marketing and Marketing Manager becoming a product that is ready for
e. Human Resource Development Manager marketed. One of them is the material or
a mixture of ingredients that still requires
58. The action taken as a measure one or more stages of further processing
What is proof in machines? to become the next product which is....
a. Design, installation, operation, performance [Link] product
b. Design, operation, installation, performance b. Packaging material
c. Operational, design, installation, performance c. Raw materials
 d. Finished product 67. Which one does not belong to the duties
e. Household products Quality Assurance (QA)?
a. Implementing supervision and
settings at each stage
63. What is included in the production flow is.... activities.
a. Personal flow b. Create protocols and supervise
b. Flow of goods/material implementation of validation.
c. Process/material unit flow c. Ensuring that packer
d. Answers a and b are correct in the process hasaccording
e. Answers a, b, and c are correct specification.
d. Document and change control
control.
64. Things what fawn yang become e. Regularly evaluating everything
considerations in transportation on specifications, analysis methods, and units
Good Distribution Practice of Medicines (CDOB)? process in the production department.
a. Temperature

b. Humidity
c. Climate 68. Air Handling Unit (AHU) is a
d. Weather variation a set of tools that can control
e. All correct some parameters to fit with
requirements room Yang has
determined. The statement is wrong
65. Complaints can be divided into two below is....
that is Pharmaceutical Technical Complaint
(PTC) and pharmacological complaint a. The filter functions to control
(PC). Which is included in the scope and control the number of particles and
Pharmaceutical Technical Complaint microorganism
(PTC) is? b. The blower functions to move
a. Medical complaint air throughout the air distribution system
b. Quality complaint and commercial c. Cooling coil functioning for
complaint controlling temperature and humidity
c. Medical complaint and quality d. Dumper to regulate the flow pattern
complaint air
d. Commercial complaint and medical e. Ducting as a closed channel where
complaint the flow of air
e. Medical complaint quality
complaint
69. A number of drugs that have properties and
uniform tissue produced in
66. The pharmaceutical industry is responsible for one cycle of creation based on an order
providing qualified personnel a certain creation is called....
in an adequate amount for
a. Lot
executing all tasks. Key personnel
in the pharmaceutical industry includes: b. Batch
c. Intermediate product
a. President Director
d. Actual results
b. Board of Directors
e. Medicine
c. Head of Production and Head
Quality Assurance section 70. Yang tasked with preparing the master
d. Marketing and Marketing Manager The formula of the pharmaceutical industry is a unit.
e. Human Resource Development Manager A. Product Development
B. Production Planning
 C. Production Process 75. Facilities for changing work clothes,
D. Product Marketing cleaning oneself and the toilet must be
E. Quality Control provided in sufficient quantity and
easy to access. Below is
Raw materials placed in the correct statement regarding facilities
quarantine status, under supervision.... supporter:
a. Marketing section a. Space rest and canteen
b. Production section beside the production area and
c. Warehouse section quality control laboratory
d. Purchasing section b. The changing room must be
e. Quality control section directly related to the area
production but located separately.
Measures to avoid contamination c. Facilities maintenance animal
they are, except.... should be properly isolated
a. Production in a separate building to other areas and equipped
b. Using a self-contained system separate entrance (animal access)
c. Using the mixing machine that air control unit that
same connected to the production area
d. The presence of air support d. Location workshop improvement and
e. Has an air suction equipment maintenance separated from
laboratory area
73. Below this is types of e. The toilet can be directly connected
qualifications, except.... with the production area or area
a. Design Qualification storage
[Link] Qualification
c. Operational Qualification 76. Authority and responsibility of the head
[Link] Qualification the Quality Assurance section includes:
[Link] a. Ensuring that production records have been
evaluated and signed by
74. Examples of incorrect personal hygiene head of Production before
is as follows.... handed over to the department head
a. Each personnel entering the area Quality Management
the creation must impose b. Providing guideline approval
protective clothing work related to production
b. All personnel must undergo and ensuring that the working instructions
health check at the time of applied accurately
recruited c. Ensuring the medicine is produced and
c. Personnel should be instructed stored accordingprocedure and
to ensure using facility meet quality requirements
washing hands and washing d. Giving approval towards
his hands before entering the area specification instructions work
production pickup sample, method
d. All hygienic practices in the area testing and monitoring procedures
the creation or other areas that another medium.
should have detrimental effects on e. Inspecting building maintenance
product quality. and facilities as well as equipment in
e. Each personnel is not allowed to smoke, production section
bring food drink
to the area of production 77. A new process/method that will
must go through a validation process
 first before it can be used. Validation c. Commercial Complaint
which is used is called: d. Critical
a. Calibration e. Comment
qualification
c. Specification 83. Below are the 3 pillars, except...
d. Validation
e. Verification a. Hardware b. Software [Link]
[Link] e. QA
78. A pharmaceutical industry has space
different classes for production 84. The following includes 3 aspects, except...
a product. Final sterilization activities a. Social b. Economy
held in the classroom:
a. Class A c. Technology [Link]
b. Class B
Class C e. Hardware
d. Class D/E
e. Class F/G 85. Process proof that something
procedures, raw materials, in accordance with the
79. The material that has been processed and expected to achieve the goal
only requires packaging activities is....
to become a finished drug is called: a. Calibration
a. Finished products b. Validation
b. Intermediate product c. Qualification
c. Household products d. Verification
d. Final product e. Specification
Intermediate product
86. Air Handling Unit (AHU) is a device
which plays an important role in the space
80. QC is the department led by
by a pharmacist to carry out production. There are several tools available.
quality control. The following is on AHU with different functions.
inspection conducted by QC, The function of the dumper is....
except: a. Controlling temperature and humidity
a. Raw material inspection the air that will be distributed to
b. Examination of semi-finished products production space
c. Finished product inspection b. Closed channel where the flow occurs
d. Inspection of packaging materials air
e. Microbiological examination c. Control and to control
the number of particles and microorganisms
81. What is not included in the hierarchy that contaminates the air that
documentation is.... entering the production space
a. Quality Manual [Link] amount air yang
b. Standards transferred to the production area
c. Standard Operating Procedure e. Moving air along
d. Quality Control connected air distribution system
e. CPOB with it

What is the defect on the product that is called 87. The following is a statement that
impact on quality product true about validation, except....
that... a. Validation provides evidence that a
a. Minor the process has been made well and
b. Major controlled
 b. Validation creates a process
to become better
c. Validation requires several processes
supporting like personal details
change control and validation
repeat
d. Qualification is part of validation.
e. Each validation process must have
Protap

88. The following are aspects that need to be

pay attention to the way of distributing the medicine that
good (CDOB), except....
A. Sampling
B. Self-inspection
C. Personal data
D. Medicine storage area
E. Documentation/Administration

89. Executing supervision and

settings at each stage of the activity
among others the production process, the analysis process,
and the system to comply with the provisions
CPOB (GMP Compliance) is
general tasks performed by....
A. Marketing
B. Quality Control
C. Research and Development
D. Administration
E. Quality Assurance

90. The following is an activity that

having a heavy relationship with production
except....
A. Personal data
B. Sanitation and Hygiene
C. Weighing
D. Equipment
E. Documentation