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Manufacture Lecture > Pharmaceutical Manufacturing Terminologies > Flashcards

Pharmaceutical Manufacturing Terminologies Flashcards

(57 cards)

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1
Q

Any substance or mixture of substance intended to be used in the manufacture of a drug product.

A

Active Pharmaceutical Ingredient

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2
Q

Substances which give a medicinal product it’s THERAPEUTIC EFFECT

A

Active Pharmaceutical Ingredient

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3
Q

An enclosed space with TWO OR MORE doors which is designed for people or goods

A

Airlock

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4
Q

A defined QUANTITY of starting material, packaging material or product processed in ONE PROCESS

A

Batch or lot

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5
Q

A DISTINCTIVE combination of number and or letters which IDENTIFIES A BATCH

A

Batch or lot number

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6
Q

Where do we put the slash? Number or letter O?

A

Number

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7
Q

Microorganisms are

A

Biological agents

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8
Q

Microorganisms include

A

Genetically engineered microorganisms
Cell cultures
Endoparasites

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9
Q

Any product completed processing stages but NOT FINAL PACKAGING

A

Bulk product

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10
Q

Set of operations UNDER SPECIFIED CONDITIONS. The relationship between values indicates by a measuring instrument or system.

A

Calibration

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11
Q

Corresponding known values of a REFERENCE STANDARD

A

Calibration

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12
Q

ENVIRONMENTAL CONTROL of particulate and microbial contamination

A

Clean area

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13
Q

Clean area is constructed to reduce

A

Introduction, generation and retention of contaminants

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14
Q

Has NO FILTRATION SYSTEM

A

Clean area

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15
Q

The action of CONFINING a biological agents

A

Containment

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16
Q

Area equipped WITH appropriate air handling and filtration

A

Contained area

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17
Q

It controls the introduction of potential contamination and consequences of accidental RELEASE OF LIVING ORGANISMS

A

Controlled area

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18
Q

System to be used for REPORTING or AUTOMATIC CONTROL

A

Computerized system

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19
Q

Contamination with ANOTHER MATERIAL

A

Cross contamination

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20
Q

Fresh or dried MEDICINAL PLANT

A

Crude plant

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21
Q

Liquefied gas at extremely LOW TEMPERATURE

A

Cryogenic vessel

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22
Q

Gas at a HIGH TEMPERATURE

A

Cylinder

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23
Q

DEPARTURE from an approved instruction

24
Q

Dosages form in FINAL IMMEDIATE PACKAGING

25
CONSTITUENT of a medicinal product
Excipient
26
The time the API is expected to remain WITHIN ESTABLISH SHELF LIFE SPECIFICATIONS
Expiry date
27
A medicinal product undergone all stages of production in it's FINAL CONTAINER.
Finished product
28
Medicinal product contained active ingredients exclusively PLANT MATERIAL
Herbal medicinal product
29
A component which is NOT THE DESIRED ENTITY
Impurity
30
Contaminated with extraneous BIOLOGICAL AGENTS
Infected
31
Checks performed during production
In-process control
32
Partly processed material
Intermediate product
33
Purchase to distribution
Manufacture
34
A manufacturer should hold a
Manufacturing authorization
35
Plant for MEDICINAL PURPOSES
Medicinal plant
36
Substance for TREATING or PREVENTING disease
Medicinal product
37
Filling and labeling
Packaging
38
Description of OPERATIONS TO BE CARRIED OUT
Procedures
39
Receipt to packaging
Production
40
SUM TOTAL of the organized arrangements
Quality assurance
41
Ensures that APIs are of GOOD QUALITY
Quality assurance
42
CHECKING or TESTING if specifications are met
Quality control
43
STATUS of a product isolated
Quarantine
44
STARTING MATERIAL
Raw material
45
Removing or correcting products
Recall
46
A COMPARISON making sure allowance for normal variations
Reconciliation
47
Extensive set of analytical tests to be AUTHENTIC MATERIAL
Reference standard
48
REWORKING a batch of unacceptable quality
Reprocessing
49
SENDING BACK to manufacturer or distributor
Return
50
VEHICLE for preparation
Solvent
51
LIST of tests or references
Specification
52
Used in the production of medicinal product EXCLUDING packaging
Starting material
53
ABSENCE of living organisms
Sterility
54
PROVING in accordance with GMP leading to expected results
Validation
55
Based on PREVIOUS LABORATORY, PILOT SCALE or MANUFACTURING DATA
Expected yield
56
Which can have loss or error? Expected or theoretical
Expected
57
ABSENCE of any loss or error
Theoretical yield

Manufacture Lecture (4 decks)

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