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IP 126 Manufacturing > Introduction > Flashcards

Introduction Flashcards

1
Q 
manufacture,
propagation,
preparation,
compounding or
processing of a drug
A

Manufacturing

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2
Q 
making by physical,
chemical, biological, or
any other procedure of
any article that meets the
definition of a drug
A

Manufacturing

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3
Q

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

A

Manufacturing

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4
Q

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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5
Q

Stages of Pharmaceutical Manufacturing

A 
Stage 1
• Primary
Manufacturing/
Processing
• API Production
Stage 2
• Secondary
Manufacturing/
Processing
• Drug Delivery
System
Production
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6
Q

recognized by monograph in the
compendia

intended for and having as their
main use the diagnosis, cure,
mitigation, treatment or prevention
of disease in man and other
animals
A

Drugs

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7
Q

means of administering drugs

as formulated preparations

A

Pharmaceutical Preparations

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8
Q

Combination of a drug entity and drug additives

A

Dosage Forms

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9
Q

Finished dosage form that contains an
active drug ingredient, generally, but not
necessarily, in association with inactive ingredients; Placebo

A

Drug Products

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10
Q 
a specific quantity of a drug or
other material that is intended
to have uniform character and
quality, within specified limits
and is produced according to a
single manufacturing order
during the same cycle of
manufacture
A

Batch

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11
Q 
a batch or a specific identified
portion of a batch having
uniform character and quality
within specified limits and a
distinctive identifying lot number
A

Lot

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12
Q 
for continuous process: specific
identified amount produced in a
unit of time or quantity in a
manner that assures its having
uniform character and quality
within specified limits
A

Lot

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13
Q 
any distinctive
combination of letters,
numbers or symbols
from which the complete
history of the
manufacture,
processing, packaging,
holding, and distribution
of a batch or lot of drug
product or other material
can be determined
A

Lot Number / Control Number /

Batch Number

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14
Q

any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of
disease or to affect the structure or function of the body of
man or other animals

A

Active Ingredient

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15
Q 
provides the drug or active
therapeutic agent in a form
suitable for administration to
a patient with assurance that
the optimum therapeutic
effects will result
A

Inactive Ingredient

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16
Q

means a processed food product intended to supplement the diet that bears or contains one or more of the following dietary ingredients:
vitamin, mineral, herb, or other botanical, amino acid, and dietary substance to increase
the total daily intake in amounts conforming to the latest Philippine recommended energy and nutrient intakes or internationally agreed minimum daily requirements

A

Food/dietary supplement

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17
Q 
an area that is marked,
designated or set aside for the
holding of incoming
components prior to
acceptance examination
A

Quarantine

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18
Q 
wireless use of electromagnetic
fields to transfer data, for the
purposes of automatically
identifying and tracking tags
attached to objects
A

Radio-frequency identification (RFID)

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19
Q

any ingredient intended for use in the manufacture of a drug product,
including those that may not appear in such product

A

Component

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20
Q

Any material fabricated, compounded, blended or derived by chemical reaction that is produced for, and used in, the preparation of the drug product

A

In-Process Material

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21
Q

given quantity of any substance or product that can further be
subdivided during the process of manufacture

A

Bulk Product

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22
Q 
records containing the
formulation, specifications,
manufacturing procedures, quality assurance requirements,
and labeling of a finished
product
A

Master Record

23
Q

quantity that would be produced at any appropriate phase of manufacturing, processing or packing of a particular drug product, based upon the quantity of components to be used, in the absence of any loss or error in actual production

A

Theoretical Yield

24
Q

Quantity that is actually produced at any appropriate phase of manufacturing, processing, or packing of a particular drug product

A

Actual Yield

25
Q

means a sole proprietorship, a partnership, a corporation, an institution, an association, or an organization engaged in
the manufacture, importation, exportation, sale, offer for sale, distribution, donation, transfer, use, testing, promotion, advertising, or sponsorship of health products including the facilities and installations needed for its activities

A

Establishment

26
Q

process of approval of an application to operate or establish an establishment

A

Licensing

27
Q

process of approval of an application to register health products

A

Registration

28
Q

a permission embodied in a document granted by the FDA to a natural or juridical person who has submitted an application to implement the
manufacture, importation, exportation, sale, offer for sale, distribution, transfer, and/or,
where appropriate, the use, testing, promotion, advertising, or sponsorship of health products

A

Authorization

29
Q

an establishment engaged in any and all operations involved in the production of health products including preparation, processing, compounding,
formulating, filling, packing, repacking, altering, ornamenting, finishing and labeling with the end in view of its storage, sale or distribution

A

Manufacturer

30
Q

T/F

A trader shall be categorized as a manufacturer

A

T

31
Q

Types of Manufacturers

A 
– Ethical Manufacturers
– Proprietary/Generic Manufacturers
– Biologicals Manufacturers
– Veterinary Products Manufacturers
– Medicinal Chemicals Manufacturers
– Toll or Contract Manufacturers
32
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

A

Trader

33
Q

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

A

Distributor/importer/exporter

34
Q

distributor/importer/exporter sells to the general public

A

retailer

35
Q

Departments in Pharmaceutical

Establishments

A 
Marketing Department
Research Department
Production Department
Quality Control Department
Engineering Department
Purchasing Department
Medical Department
36
Q

• promotes the maximum volume of sales of
products
• provides professional service through intelligent
presentation
• handles advertising through direct mail
professional journals
• sponsors conventions, meetings
• handles marketing surveys which assess the
chances of a product in the market

A

Marketing Department

37
Q 
• develops new products
• improves existing products
• handles research activities
• requires facilities such as a library, a pilot plant,
and an animal house
A

Research Department

38
Q

• receives materials and supplies
• oversees warehousing and storage and shipping
of the final product to customers
• manufactures and packages products
• exercises production, personnel, labeling and
packaging control

A

Production Department

39
Q
  • performs sampling, testing, and assaying of products

* records and compiles results

A

Quality Control Department

40
Q
  • locates and installs equipment
  • maintains and repairs equipment
  • maintains plant services
  • ensures plant and employee safety
A

Engineering Department

41
Q

purchases, receives and inventories supplies

A

Purchasing Department

42
Q

• conducts physical and medical examination of new employees
• oversees the medical treatment of employees
• performs clinical studies
– Clinical Research Associate
• prepares literature and package inserts
• publishes house organ
• handles scholarships

A

Medical Department

43
Q

guide, prescribe, control conduct of members of an organization

A

Regulation

44
Q

established guidelines, specifications, or legislation

A

Compliance

45
Q

GMP

A

Good Manufacturing Practice

46
Q

PIC/S

A

Pharmaceutical Inspection Cooperation Scheme

47
Q

ICH

A

International Conference on Harmonization

48
Q

quality approach to manufacturing, to minimize or eliminate instances of contamination, mixups, and errors

A

GMP

49
Q

informal co-operative arrangement between

Regulatory Authorities in the field of GMP of medicinal products for human or veterinary use

A

PIC/S

50
Q

global streamlining of the drug development process and

marketing approval

A

ICH

51
Q

single floor plant layout

A

Horizontal Flow

52
Q

tower type plant layout

A

Vertical Flow

53
Q

Basic Principles of Materials Handling

A
  1. Short distances
  2. Short terminal times
  3. Two-way payloads
  4. Avoid partial loads
  5. Avoid manual handling
  6. Move scrap cheaply
  7. Gravity is the cheapest power
  8. Move in straight lines
  9. Unit loads
  10. Label thoroughly

IP 126 Manufacturing (3 decks)

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