Introduction

Question 1

manufacture,
propagation,
preparation,
compounding or
processing of a drug

Answer 1

Manufacturing

Question 2

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

Answer 2

Manufacturing

Question 3

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

Answer 3

Manufacturing

Question 4

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

Answer 4

Manufacturing

Question 5

Stages of Pharmaceutical Manufacturing

Answer 5

Stage 1
• Primary
Manufacturing/
Processing
• API Production

Stage 2
• Secondary
Manufacturing/
Processing
• Drug Delivery
System
Production

Question 6

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

Answer 6

Drugs

Question 7

means of administering drugs

as formulated preparations

Answer 7

Pharmaceutical Preparations

Question 8

Combination of a drug entity and drug additives

Answer 8

Dosage Forms

Question 9

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

Answer 9

Drug Products

Question 10

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

Answer 10

Batch

Question 11

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

Answer 11

Lot

Question 12

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

Answer 12

Lot

Question 13

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

Answer 13

Lot Number / Control Number /

Batch Number

Question 14

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

Answer 14

Active Ingredient

Question 15

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

Answer 15

Inactive Ingredient

Question 16

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

Answer 16

Food/dietary supplement

Question 17

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

Answer 17

Quarantine

Question 18

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

Answer 18

Radio-frequency identification (RFID)

Question 19

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

Answer 19

Component

Question 20

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

Answer 20

In-Process Material

Question 21

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

Answer 21

Bulk Product

Question 22

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

Answer 22

Master Record

Question 23

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

Answer 23

Theoretical Yield

Question 24

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

Answer 24

Actual Yield

Question 25

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

Answer 25

Establishment

Question 26

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

Answer 26

Licensing

Question 27

process of approval of an application to register health products

Answer 27

Registration

Question 28

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

Answer 28

Authorization

Question 29

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

Answer 29

Manufacturer

Question 30

T/F | A trader shall be categorized as a manufacturer

Answer 30

T

Question 31

Types of Manufacturers

Answer 31

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

Question 32

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

Answer 32

Trader

Question 33

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

Answer 33

Distributor/importer/exporter

Question 34

distributor/importer/exporter sells to the general public

Answer 34

retailer

Question 35

Departments in Pharmaceutical | Establishments

Answer 35

``` Marketing Department Research Department Production Department Quality Control Department Engineering Department Purchasing Department Medical Department ```

Question 36

• 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

Answer 36

Marketing Department

Question 37

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

Answer 37

Research Department

Question 38

• 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

Answer 38

Production Department

Question 39

* performs sampling, testing, and assaying of products | * records and compiles results

Answer 39

Quality Control Department

Question 40

* locates and installs equipment * maintains and repairs equipment * maintains plant services * ensures plant and employee safety

Answer 40

Engineering Department

Question 41

purchases, receives and inventories supplies

Answer 41

Purchasing Department

Question 42

• 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

Answer 42

Medical Department

Question 43

guide, prescribe, control conduct of members of an organization

Answer 43

Regulation

Question 44

established guidelines, specifications, or legislation

Answer 44

Compliance

Question 45

GMP

Answer 45

Good Manufacturing Practice

Question 46

PIC/S

Answer 46

Pharmaceutical Inspection Cooperation Scheme

Question 47

ICH

Answer 47

International Conference on Harmonization

Question 48

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

Answer 48

GMP

Question 49

informal co-operative arrangement between | Regulatory Authorities in the field of GMP of medicinal products for human or veterinary use

Answer 49

PIC/S

Question 50

global streamlining of the drug development process and | marketing approval

Answer 50

ICH

Question 51

single floor plant layout

Answer 51

Horizontal Flow

Question 52

tower type plant layout

Answer 52

Vertical Flow

Question 53

Basic Principles of Materials Handling

Answer 53

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