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Manufacture Lecture > Pharmaceutical Manufacturing Terminologies > Flashcards

Pharmaceutical Manufacturing Terminologies Flashcards

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

A

Deviation

24
Q

Dosages form in FINAL IMMEDIATE PACKAGING

A

Drug Product

25
Q

CONSTITUENT of a medicinal product

A

Excipient

26
Q

The time the API is expected to remain WITHIN ESTABLISH SHELF LIFE SPECIFICATIONS

A

Expiry date

27
Q

A medicinal product undergone all stages of production in it’s FINAL CONTAINER.

A

Finished product

28
Q

Medicinal product contained active ingredients exclusively PLANT MATERIAL

A

Herbal medicinal product

29
Q

A component which is NOT THE DESIRED ENTITY

A

Impurity

30
Q

Contaminated with extraneous BIOLOGICAL AGENTS

A

Infected

31
Q

Checks performed during production

A

In-process control

32
Q

Partly processed material

A

Intermediate product

33
Q

Purchase to distribution

A

Manufacture

34
Q

A manufacturer should hold a

A

Manufacturing authorization

35
Q

Plant for MEDICINAL PURPOSES

A

Medicinal plant

36
Q

Substance for TREATING or PREVENTING disease

A

Medicinal product

37
Q

Filling and labeling

A

Packaging

38
Q

Description of OPERATIONS TO BE CARRIED OUT

A

Procedures

39
Q

Receipt to packaging

A

Production

40
Q

SUM TOTAL of the organized arrangements

A

Quality assurance

41
Q

Ensures that APIs are of GOOD QUALITY

A

Quality assurance

42
Q

CHECKING or TESTING if specifications are met

A

Quality control

43
Q

STATUS of a product isolated

A

Quarantine

44
Q

STARTING MATERIAL

A

Raw material

45
Q

Removing or correcting products

A

Recall

46
Q

A COMPARISON making sure allowance for normal variations

A

Reconciliation

47
Q

Extensive set of analytical tests to be AUTHENTIC MATERIAL

A

Reference standard

48
Q

REWORKING a batch of unacceptable quality

A

Reprocessing

49
Q

SENDING BACK to manufacturer or distributor

A

Return

50
Q

VEHICLE for preparation

A

Solvent

51
Q

LIST of tests or references

A

Specification

52
Q

Used in the production of medicinal product EXCLUDING packaging

A

Starting material

53
Q

ABSENCE of living organisms

A

Sterility

54
Q

PROVING in accordance with GMP leading to expected results

A

Validation

55
Q

Based on PREVIOUS LABORATORY, PILOT SCALE or MANUFACTURING DATA

A

Expected yield

56
Q

Which can have loss or error?
Expected or theoretical

A

Expected

57
Q

ABSENCE of any loss or error

A

Theoretical yield

Manufacture Lecture (4 decks)

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