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PANGIT > 1 > Flashcards

1 Flashcards

1
Q

The manufacture, propagation, preparation, processing of drug in a large scale (mass production)

A

MANUFACTURING

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2
Q

Prescription order; specific for a particular patient; small scale

A

EXTEMPORANEOUS COMPOUNDING

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3
Q

Producing small quantities of product for sensory, chemical, microbiological evaluations, clinical testing, limited market testing or furnishing samples to potential customers, shelf-life and storage stability studies

A

PILOT PLANT

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4
Q

Providing data that can be used in making a decision on whether or not to proceed to a full-scale production process; and in the case of a positive decision, designing and constructing a full-size plant or modifying an existing plant

A

PILOT PLANT

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5
Q

the making by physical, chemical, biological, or any other procedure of any article that meets the definition of drugs.

A

MANUFACTURING

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6
Q

the manipulation, sampling, testing, or control procedures applied to the final product or any part of the process.

A

MANUFACTURING

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7
Q

the packaging, repacking, or changing the container, wrapper, or label of any drug package in preparation for its distribution from the manufacturer to the final user.

A

MANUFACTURING

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8
Q

large-scale production of a drug products

A

MANUFACTURING

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9
Q

4 stages of manufacturing

A

• DISPENSING OF RAW MATERIALS
• PROCESSING OF DOSAGE FORMS
• FILLING
• PACKAGING AND REPACKING

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10
Q

4 Mfg activities

A

• PRIMARY MFG
• SECONDARY MFG
• TERTIARY MFG
• TOLL MFG

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11
Q

Manufacturing of raw materials

A

PRIMARY MFG

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12
Q

Manufacturing of dosage forms

A

SECONDARY MFG

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13
Q

Packaging, labeling or repacking of bulk finished products.

A

TERTIARY MFG

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14
Q

An arrangement whereby a competent company manufacturers the product for another company.

A

TOLL MFG

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15
Q

Any organization or company involved in the manufacture, importation, repacking and/ot distribution of drug or medicines.

A

DRUG ESTABLISHMENT

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16
Q

Revised Regulations for the Licensing of Drug Establishments and Outlets

A

AO 56 s. 1989

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17
Q

Rules and Regulations on the Licensing of Establishments Engaged in the Manufacture, Conduct of Clinical Trial, Distribution, Importation, Exportation, Drugstore and Retailing of Drug Products, and Issuance of RONPD Other Related
Sponsor Authorizations

A

AO 2014-0034

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18
Q

Involved in production of drug products (preparatory processing, compounding, formulating, filling, packaging, repacking, altering, ornamenting, finishing, labeling)

A

DRUG MANUFACTURER

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19
Q

Involved in packaging of bulk drug product to its immediate container.

A

DRUG MANUFACTURER- PACKER

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20
Q

Involved in repacking of finished product into smaller quantities in a separate container and/or secondary packaging.

A

DRUG MANUFACTURER - REPACKER

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21
Q

Registered owner of drug product and formulation but subcontracts manufacturing.

A

DRUG MANUFACTURER - TRADER

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22
Q

Procures RM and PM
Provides monographs and QC protocols

A

DRUG MANUFACTURER- TRADER

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23
Q

Imports RM, API, and/or finished products for wholesale distribution to other licensed establishments.

A

DRUG DISTRIBUTOR - IMPORTER

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24
Q

Exports RM, APU, and/or finished products for wholesale distribution to establishments outside the country.

A

DRUG DISTRIBUTOR - EXPORTER

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25
Q

Procures RM, APU, and/or finished products from a local licensed establishment for local distribution in wholesale basis

A
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26
Q

any establishment engaged in operations involved in the production of drugs, including propagation, processing, compounding, finishing, filling, packing, repacking, altering, or ornamenting with the end in view of storage, distribution or sale of the product

A

DRUG MANUFACTURER

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27
Q

Any establishment that imports/exports raw materials, active ingredients, and/or finished products for its own distribution or for wholesale distribution to other establishments or outlets.

A

DRUG IMPORTER/EXPORTER

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28
Q

any establishment which is a registered owner of the drug product, procures the materials and packaging components and provides the production monographs, quality control standards and procedures, but subcontracts the manufacture of such products to a licensed manufacturer

• also engaged in the distribution and/or marketing of its products.

A

DRUG TRADER

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29
Q

procures raw materials, active ingredients and/or finished products from a local establishment for local distribution on wholesale basis

A

DRUG DISTRIBUTOR/ WHOLESALER

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30
Q

Included manufacturers, importerd and traders of drugs.

A

DRUG SUPPLIER

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31
Q

It formulates new products

A

RESEARCH AND DEVELOPMENT (R&D) DEPT.

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32
Q
  • involved in process development and scale-up
  • prepares the master formula
  • justifies any overages in the formula
  • improved existing products
A

RESEARCH AND DEVELOPMENT (R&D) DEPT.

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33
Q

It contains the formulation, sepcifications, manufacturing procedures, OA requirements, and labeling of a finished product

A

MASTER FORMULA

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34
Q

It deals with all stages of mfg batches of finished drug products

A

PRODUCTION DEPT

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35
Q

Specific quantity of product intended to have uniform character and quantity, produced during the same single cycle of manufacture

A

BATCH

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36
Q

Specific identified portion of a batch

A

LOT

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37
Q

-plans the production according to MO
- accomplished the BMR to ensure that batches were properly made and tests were conducted

A

PRODUCTION DEPT.

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38
Q

Stores materials and finished products

A

WAREHOUSE DEPT

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39
Q

Holds incoming components in the quarantine area

A

WAREHOUSE DEPT

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40
Q

Involved in purchasing and logistics

A

WAREHOUSE DEPT

41
Q

Assures all operations meet the required standards of safety and efficacy (cGMP)

Conducts quality audit and monitoring

Prepares SOPs

A

QUALITY ASSURANCE (QA) DEPT.

42
Q

Test compliance of materials and finished products to specifications

A

QUALITY CONTROL DEPT

43
Q

Conducts sampling of materials

A

QUALITY CONTROL DEPT

44
Q

Performs IPQC and environmental testing

A

QUALITY CONTROL DEPT

45
Q

Studies current market trends, consumers, behavior, and product status in the market

A

MARKETING DEPT

46
Q

Advertisement and promotion

A

MARKETING DEPT

47
Q

Accomplished the BMR to ensure that batches were properly made and tests were conducted

A

PRODUCTION DEPT

48
Q

Document containing the details of the manufacture of each batch

A

BATCH MANUFACTURING RECORD (BMR)

49
Q

Document containing the details of the manufacture of each batch

A

BATCH MANUFACTURING RECORD (BMR)

50
Q

Status if materials which are isolated physically while a decision us awaited on their release, rejection ir reprocessing.

A

QUARANTINE

51
Q

Step-by-step instructions for performing operational tasks or activities

A

STANDARD OPERATING PROCEDURE (SOP)

52
Q

Ensures compliance with all pertinent regulations and laws about drugs and their marketing

A

REGULATORY

53
Q

Installs, maintains and repairs equipment and premises

A

ENGINEERING DEPT

54
Q

Conducts validation and qualification

A

ENGINEERING DEPT

55
Q

Action of proving and documenting that any process, procedure or method actually and consistently leads to the expected results

A

VALIDATION

56
Q

LTO

A

License to Operate

57
Q

CPR

A

Certificate of Product Registration

58
Q

Action of proving that premises, systems or equipments work correctly and actually lead to expected results

A

QUALIFICATION

59
Q

• Ensures safety

A

ENGINEERING DEPARTMENT

60
Q

• concerned with the physical exam and medical tx of employees

A

MEDICAL

61
Q

• performs clinical studies

A

MEDICAL

62
Q

Publishes house organ/paper

A

MEDICAL DEPARTMENT

63
Q

Purchases, receives and makes inventories of supplies

A

PURCHADING DEPARTMENT

64
Q

10 Departments in a Manufacturing Company

A

• RESEARCH AND DEVELOPMENT DEPTARTMEMT
• PRODUCTION DEPARTMENT
• WAREHOUSE DEPARTMENT
• QUALITY ASSURANCE DEPARTMENT
• QUALITY CONTROL DEPARTMENT
• MARKETING DEPARTMENT
• REGULATORY DEPARTMENT
• ENGINEERING DEPARTMENT
• MEDICAL DEPARTMENT
• PURCHASING DEPARTMENT

65
Q

Refers to the pharmaceutical research and manufacturing companies providing pharmacist with medicines in pre-fabricated or ready to take forms.

A

INDUSTRIAL PHARMACY

66
Q

Is a mechanism for determining and assigning duties to people, in order to work effectively.

A

ORGANIZATION

67
Q

A combination of manpower, money, machines and methods so coordinated that they can fulfill an economic objective

A

BUSINESS ORGANIZATION

68
Q

Organizational Planning is Interpreted as a?

A

CHART

69
Q

The first basic tool of an organization

A

ORGANIZATIONAL PLANNING

70
Q

The second basic tool of an organization

A

POSITIONAL DESCRIPTION

71
Q

This will clearly define the authority, duty or responsibility of the areas in the chart?

A

POSITIONAL DESCRIPTION

72
Q

The third basic tool of an organization?

A

ORGANIZATION MANUAL

73
Q

Organization Manual is also referred to as the?

A

MANAGEMENT GUIDE

74
Q

This combines the chart and position descriptions, with description materials about the organization to provide all levels of management a clear understanding of the organization plan, top management, philosophy and objectives of the company

A

MANAGEMENT GUIDE

75
Q

3 levels of Top Management

A

LEVEL I
LEVEL II
LEVEL III

76
Q

This Usually consist of the Board if Trustees or Board of Directors?

A

LEVEL I

77
Q

Consist of the President, the function being general, management or administrative .

A

LEVEL II

78
Q

This level of management includes active planning, direction, coordination and control of the business with the scope of policies established and authorized by the level I management.

A

LEVEL II

79
Q

Consist of the Vice- President, General Managers, and department Managers. The functions include management of the major departments of the company. They are fully responsible and accountable to the level II management for the success of their respective operations.

A

LEVEL III

80
Q

embraces the topmost level of executives concerned with a particular division of the company rather than the enterprise as a whole.

A

LEVEL III

81
Q

Consitutes the framework for the organizational structure

A

LINE

82
Q
  • Are those that have direct responsibility to accomplish the objectives of these enterprise.
  • It has the power or authority to initiate and carry through other primary activities necessary to reach the stated goals of the company
A

LINE FUNCTIONS

83
Q

the chain of command from the top to the bottom of the organization?

A

LINE FUNCTIONS

84
Q

Constitutes the work functions or the organization components that are required to supply information and service to the “line” components.

A

STAFF

85
Q

In charge of purchasing requisitioned material (both packaging materials and raw materials). Both from local and imported sources.

A

PURCHASING

86
Q

3 production control:

A

PURCHASING
INVENTORY CONTROL
PLANNING AND SCHEDULING

87
Q

Watches and monitors closely. Records all materials used in the production:

A

INVENTORY CONTROL

88
Q

Coordinates with then marketing department on what products and required for supply, and then plans and schedules the manufacture of the product.

A

PLANNING AND SCHEDULING

89
Q

3 subdivisions of Raw materials:

A

QUARANTINE AREA
APPROVED FOR USE AREA
REJECT AREA

90
Q

Are labeled with yellow-coded labels bearing the word “QUARANTINE”. This implies that the materials are subject to test and assays by the quality control section and are not yet to be used.

A

QUARANTINE MATERIALS

91
Q

Are labeled with green coded labels with the bold letters “APPROVED FOR USE”.

A

APPROVED FOR USE MATERIALS

92
Q

The materials from the quarantine area found to conform to the standards and
specifications are transferred to the Approved for use area. Replacing the quarantine label with the Approved for use label.

A

APPROVED FOR USE MATERIALS

93
Q

are those found to be substandard are transferred from the quarantine are to the rejected area. The quarantine stickers are replaced with the red-coded stickers bearing the bold letters “REJECTED” these materials are either returned to the supplier (for replacement) or disposed of properly

A

REJECTED MATERIALS

94
Q

This section consist of product which have been bottled, stripped or packed, but not yet labeled or packed into boxes or cartons, because they still await the results of the quality control test and assays as well as the final disposition

A

IN-PROCESS

95
Q

This area contains the products packaged and finished and are ready for distribution and sale.

A

FINISHED PRODUCTS/GOODS

96
Q

In as much returns cannot be avoided, the products returned are stored in this section of the warehouse, pending disposition by the Quality Control.

A

RETURNED GOODS

97
Q

Is an area in the warehouse where raw materials for use in the production are weighed and or/measured. The packaging materials are also counted upon issuance. A quality control checker should be present in this area, to avoid errors, the inspector also perform routine checking in all sections of the warehouse.

A

DISPENSING

98
Q

Takes charge of the care, maintenance and repair of all machines and equipment used in the Plant Department, including electrical lines, water and sewerage aquatics, waste management, telecommunication lines, environment sanitation, etc.

A

ENGINEERING AND MAINTENANCE SECTION

PANGIT (3 decks)

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