Manufacturing Pharmacy - [Batch 2 Practice Question Part 1-2]

Proverbs 16:3

c) PET

1. Plastic for beverages, have transparency and luster, can undergo gamma radiation.
   a) PVC
   b) PP
   c) PET
   d) PE

b) PP

2. Plastic that is autoclavable
   a) PVC
   b) PP
   c) PET
   d) PE

a) Packaging

3. An economical means of providing presentation, protection, preservation, identification, information, containment, convenience, and compliance for a drug product
   a) Packaging
   b) Excipient
   c) Final Adjuvant
   d) Colorant

e) None of the above

4. Importance of the provisions of cGMP, except:
   a) Prevents substandard, contaminated, or adulterated products.
   b) Reduces batch-to-batch variation through standardized procedures.
   c) Minimizes cross-contamination and labeling errors.
   d) Allows tracing of errors, deviations, or product recalls when needed.
   e) None of the above

c) Man or operator

5. ______ are trained to carry out procedures correctly.
   a) Machine
   b) Material
   c) Man or operator
   d) Method

a) Critical

6. _______ steps of manufacturing process and significant changes to the process validated
   a) Critical
   b) Minor
   c) Simple
   d) Secondary

a) Quality Assurance

7. It is a wide-ranging concept which covers all matter which individually or collectively influence the quality of a product
   a) Quality Assurance
   b) PQS
   c) Quality
   d) cGMP

a) Quality Assurance

8. The total of the organized arrangements made with the object of ensuring that medicinal products are of the quality for their intended use.
   a) Quality Assurance
   b) PQS
   c) Quality
   d) cGMP

d) cGMP

9. Part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use.
   a) Quality Assurance
   b) PQS
   c) Quality
   d) cGMP

d) Quality

10. Refers to the perception of the degree to which the product or service meets the customer's expectation.
    a) Quality Assurance
    b) Product Development
    c) Manufacturing
    d) Quality

c) USFDA

11. cGMP were first promulgated by the ________ in 1963; and finalized in 1979.
    a) EU PIC
    b) ASEAN Directive
    c) USFDA
    d) PIC/S

d) Packaging

12. Section that is in charge with transferring the bottled, stripped, or packed products to the in-process area of the warehouse.
    a) Production
    b) Dispensing
    c) Warehouse
    d) Packaging

a) QC staff

13. In charged personnel that perform in-process tests while the product is compounded.
    a) QC staff
    b) QC head
    c) QA manager
    d) RPh

b) QC head

14. In charge personnel for the preparation of the master formula if the master formula is not the actual amount to be manufactured.
    a) QC staff
    b) QC head
    c) QA manager
    d) RPh

d) Price

15. The master formula consists of the following information, except:
    a) Name of the product
    b) Potency of the AI
    c) Amount yield
    d) Price

d) A&B

16. Personnel that are in charge of the preparation of the master formula.
    a) Research Department (if locally)
    b) Parent Company (if abroad)
    c) QA Department
    d) A&B

a) Dispensing Section

17. Area where raw materials for use in the production are weighed and/or measured.
    a) Dispensing Section
    b) Raw Material Section
    c) In-Process
    d) Production

a) Rejected

18. Materials that are found to be substandard
    a) Rejected
    b) Approved for Use
    c) Quarantined
    d) Bulk

b) Planning and Scheduling

19. Coordinates with the marketing department on what products are required for supply
    a) Purchasing
    b) Planning and Scheduling
    c) Inventory
    d) Warehouse

a) Filtration

20. The sterility of a solution for injection containing a heat labile API may be assured by which of the following?
    a) Filtration
    b) Aseptic
    c) UV radiation
    d) AOTA

a) Certificate of Analysis

21. Document with the results of all tests conducted on material to show compliance or non-compliance with the standard specifications.
    a) Certificate of Analysis
    b) Master Formula
    c) Manufacturing Order
    d) Monograph

c) Lot

22. A specific identified portion of a batch
    a) Batch Size
    b) Batch Quantity
    c) Lot
    d) Lot Number

b) Drug Trader

23. Registered owner of the drug product but subcontracts toll manufacture of such products to a licensed manufacturer.
    a) Toll manufacturer
    b) Drug Trader
    c) Wholesaler
    d) Distributor

a) Wholesaler

24. Procures raw materials, AI, and or finished products from local establishments. (RA 9711)
    a) Wholesaler
    b) Exporter
    c) Importer
    d) Retailer

c) Manufacturing

25. The complete set of activities to produce a drug that comprise production and quality control from dispensing of materials to the release for distribution of the finished product.
    a) Quality Assurance
    b) Product Development
    c) Manufacturing
    d) Quality

a) Gravimetric

26. The filling method employed for highly viscous fluids is
    a) Gravimetric
    b) Volumetric
    c) Constant Level
    d) NOTA

c) Impact

27. Method of milling that involves the use of hammers or bars at high speed
    a) Shearing
    b) Compression
    c) Impact
    d) Attrition

c) SOP

28. Step-by-step instructions for performing operational tasks or activities
    a) COA
    b) MR
    c) SOP
    d) GMP

d) Die

29. Part of the tableting machine that is responsible for the shape of the tablet.
    a) Hopper
    b) Feed frame
    c) Punch
    d) Die

c) Quality Control

30. Department of drug manufacturing establishment responsible for evaluating if the drug products comply to standards prior market release.
    a) Research and Development
    b) Production
    c) Quality Control
    d) Engineering

c) PET

31. Plastic for beverages, have transparency and luster, can undergo gamma radiation.
    a) PVC
    b) PP
    c) PET
    d) PE

d) cGMP (Good Manufacturing Practice)

32. Part of quality assurance which ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use.
    a) Quality Assurance
    b) Quality Control
    c) SOP
    d) cGMP (Good Manufacturing Practice)

a) Flooding

33. An uncontrolled, excessive, and often unpredictable flow of material, which behaves more like a liquid than a solid.
    a) Flooding
    b) Arching
    c) Funneling
    d) Bridging

a) In-Use Stability Studies

34. Assess the stability of a product after it has been opened or prepared for use.
    a) In-Use Stability Studies
    b) Accelerated Stability Studies
    c) Real-Time Stability Studies
    d) Shelf-Life Extension Studies

a) Genosomes

35. A novel carrier for topical delivery that is an artificial macromolecular complex that facilitate the transmission of functional genes.
    a) Genosomes
    b) Aquasomes
    c) Novasomes
    d) Transferosomes

a) Fluidized-bed granules

36. Similar to those prepared by the wet massing process, but possess greater porosity and the granule surface is covered by a film of binding agent.
    a) Fluidized-bed granules
    b) Slugging granules
    c) Spray-dried systems
    d) Milled granules

a) Conisnap

37. Two halves of the capsules shell to be positively joined through locking-grooves in the shell walls.
    a) Conisnap
    b) Pulvules
    c) Qualicaps
    d) Torpac

a) Stability

38. Capacity of drug to remain within specifications
    a) Stability
    b) Quality
    c) Shelf-life
    d) Sterilization

a) Picking

39. Isolated areas of film are pulled away from the surface when the tablet sticks together and then part.
    a) Picking
    b) Chipping
    c) Cratering
    d) Blooming

a) Aquasomes

40. A carrier for topical delivery that are three-layered self-assembly composition with a ceramic nanocrystalline particle core and a glassy layer of polyhydroxy chemicals that have potent adjuvant effect.
    a) Aquasomes
    b) Genosomes
    c) Novasomes
    d) Transferosomes

a) Dispensing Section

41. Area where raw materials for use in the production are weighed and/or measured. The packaging materials are also counted upon issuance.
    a) Dispensing Section
    b) Raw Material Section
    c) In-Process Section
    d) Warehouse Section

a) Rejected materials

42. These materials are either returned to the supplier (for replacement) or disposed of properly.
    a) Rejected materials
    b) Quarantined materials
    c) Approved materials
    d) Bulk materials

a) Pulvules

43. A modern design for capsules that have a tapering body and rounded cap end features.
    a) Pulvules
    b) Conisnap
    c) Qualicaps
    d) Torpac

a) PVC / Polyvinyl chloride

44. A type of plastic used for blister packaging.
    a) PVC / Polyvinyl chloride
    b) PP / Polypropylene
    c) PET / Polyethylene terephthalate
    d) PE / Polyethylene

a) Shelf-Life Extension Studies

45. A stability study that is limited to products already close to their expiry date and may not be applicable for all products.
    a) Shelf-Life Extension Studies
    b) Accelerated Stability Studies
    c) Real-Time Stability Studies
    d) In-Use Stability Studies

a) Novasomes

46. It's made up of glyceryl dilaurate, cholesterol and polyxyethylene 10-stearyl ether, used to deliver drugs to the pilosebaceous compartment.
    a) Novasomes
    b) Aquasomes
    c) Genosomes
    d) Transferosomes

a) Soft shell capsule

47. Shells that are prepared with the addition of glycerin or a polyhydric alcohol to render them elastic.
    a) Soft shell capsule
    b) Hard shell capsule
    c) Pulvule
    d) Gelcap

a) Inventory Control

48. In charge of checking stocks periodically.
    a) Inventory Control
    b) Production Control
    c) Quality Control
    d) Warehouse Management

a) Qualicaps

49. Distinctive looking capsules with colored bands of gelatin.
    a) Qualicaps
    b) Conisnap
    c) Pulvules
    d) Torpac

a) Accelerated Stability Study

50. Assess the product's stability under elevated stress conditions to predict its shelf life more quickly.
    a) Accelerated Stability Study
    b) Real-Time Stability Study
    c) In-Use Stability Study
    d) Shelf-Life Extension Study

a) Gravity Filtration

51. It provides slow filtration.
    a) Gravity Filtration
    b) Pressure Filtration
    c) Vacuum Filtration
    d) Series Filtration

a) Flaking

52. Coating material that is easily removed from the product in sheets after coating.
    a) Flaking
    b) Chipping
    c) Blooming
    d) Blushing

a) Slugging

53. A process in dry granulation wherein a large tablet is produced in a heavy-duty tableting press.
    a) Slugging
    b) Roller compaction
    c) Wet massing
    d) Fluidized bed granulation

a) In Process Section

54. Consists of products which have been bottled, stripped or packed, but not yet labelled or packed into boxes or cartons.
    a) In Process Section
    b) Raw Material Section
    c) Finished Goods Section
    d) Bulk Section

a) Production Control

55. In-charge in preparation of manufacturing order and finishing order.
    a) Production Control
    b) Inventory Control
    c) Quality Control
    d) Planning and Scheduling

a) Airlock

56. Enclosed space with two or more doors, which is interposed between two or more rooms, for the purpose of controlling the airflow between those rooms when they need to be entered.
    a) Airlock
    b) Clean room
    c) Ante room
    d) Pass-through

a) Felt cloth

57. A filter media that is used to filter gelatinous solutions.
    a) Felt cloth
    b) Filter cloth
    c) Kraft paper
    d) Nylon cloth

a) Constant Level Method

58. A liquid filling method that makes use of container height as the means of controlling the fill amount of each bottle.
    a) Constant Level Method
    b) Gravimetric Method
    c) Volumetric Method
    d) Pressure Method

a) Rotary Die Process

59. A continuous process used for manufacturing soft gelatin capsules, providing an efficient and high-speed production process.
    a) Rotary Die Process
    b) Plate Process
    c) Reciprocating Die Process
    d) Accogel Machine

a) Gelcap

60. Capsule-shaped tablets that allow the product to be smaller than a capsule filled with an equivalent amount of powder.
    a) Gelcap
    b) Pulvule
    c) Softgel
    d) Conisnap

a) Mechanical Stirrers

61. This equipment is ideal for slow mixing of finished emulsions, which have been prepared by melting the waxes.
    a) Mechanical Stirrers
    b) Homogenizers
    c) Ultrasonifiers
    d) Laminar Flow Enclosures

a) Lot

62. A specific identified portion of a batch.
    a) Lot
    b) Batch Size
    c) Batch Quantity
    d) Lot Number

a) Funneling

63. A non-ideal flow pattern where an active channel of moving material forms only in the center of the hopper, while the material near the walls remains stationary or "dead".
    a) Funneling
    b) Flooding
    c) Arching
    d) Bridging

a) Spray-Dried Systems

64. In this process the granules consist of spherical particles composed of an outer shell and an inner core of particles.
    a) Spray-Dried Systems
    b) Fluidized-Bed Granules
    c) Slugging
    d) Wet Massing

a) Laminar Flow Enclosures

65. This equipment has been developed to allow for the draft-free flow of clean, filtered air over the work area.
    a) Laminar Flow Enclosures
    b) Fume Hood
    c) Biosafety Cabinet
    d) Clean Bench

a) Quality Assurance

66. The total of the organized arrangements made with the object of ensuring that medicinal products are of the quality required for their intended use.
    a) Quality Assurance
    b) Quality Control
    c) cGMP
    d) Quality Management System

a) Quality

67. It refers to the perception of the degree to which the product or service meets the customer's expectations.
    a) Quality
    b) Quality Assurance
    c) Quality Control
    d) Conformance

a) Blooming

68. A problem in coating wherein the coating becomes dull immediately or after prolonged storage at high temperatures.
    a) Blooming
    b) Blushing
    c) Chipping
    d) Cratering

a) Transferosomes (Elastic Liposomes)

69. A carrier in topical delivery is the ______ that holds and transports the active drug to the skin surface and, when needed, into or across the skin.
    a) Transferosomes (Elastic Liposomes)
    b) Aquasomes
    c) Novasomes
    d) Genosomes

a) Homogenizers / Colloids Mills

70. The high shearing stress equipment that can produce extremely fine droplets, depending on the viscosity and interfacial tension of the system.
    a) Homogenizers / Colloids Mills
    b) Mechanical Stirrers
    c) Ultrasonifiers
    d) Laminar Flow Enclosures