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Manufacturing Pharm > Unit 1 Terms > Flashcards

Unit 1 Terms Flashcards

1
Q

Contaminated with extraneous biological agents and capable of spreading infection

A

INFECTED

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2
Q

Checks performed during production to monitor and if necessary to adjust the process to ensure that the product conforms its specifications

A

IN-PROCESS CONTROL

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3
Q

Partly processed material which must undergo further manufacturing

A

INTERMEDIATE PRODUCT

before bulk product

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4
Q

All operations

A

MANUFACTURE

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5
Q

company holding a “manufacturing authorization”

A

MANUFACTURER

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6
Q

Whole plant or part which is used for medicinal purposes

A

MEDICINAL PLANT

processed

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7
Q

Substances that give its therapeutic effect

A

ACTIVE PHARMACEUTICAL INGREDIENT (API)

“Active Substance” or “Drug Substance.”

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8
Q

Enclosed space nterposed between two or more rooms of differing class of cleanliness for the purpose of controlling the airflow between those
rooms when they need to be entered.

A

AIRLOCK

Anteroom

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9
Q

defined quantity processed in one process or series of processes expected to be homogeneous

A

BATCH (or LOT)

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10
Q

distinctive combination of numbers and/or letters which specifically identifies a batch

A

BATCH NUMBER (or LOT NUMBER)

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11
Q

Microorganisms, whether pathogenic or not

A

BIOLOGICAL AGENTS

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12
Q

product which has completed processing stages but not including final packaging

A

BULK PRODUCT

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13
Q

area with defined environmental control of particulate and microbial contamination

A

CLEAN AREA

whole area in general

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13
Q

set of operations which establish, under specified conditions of known
values of a reference standard in measuring instrument or measuring system

A

CALIBRATION

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14
Q

An area constructed and operated in such manner that will achieve the aims of both a clean area and a contained area at the same time

A

CONTAINED AREA

specific room
synonymous with CONTAINMENT

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15
Q

confining a biological agent or other entity within a defined space

A

CONTAINMENT

e.g. use of a HEPA filter
synonymous with CONTAINED AREA

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16
Q

area constructed and operated equipped with appropriate air handling and filtration to prevent contamination of external environment by biological agents

A

CONTAINED AREA

strictest area

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17
Q

system of input of data, electronic processing and the output of information to be used either for reporting or automatic control.

A

COMPUTERIZED SYSTEM

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18
Q

Contamination with another material or product.

A

CROSS-CONTAMINATION

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19
Q

Fresh or dried medicinal plant or parts

A

CRUDE PLANT

(VEGETABLE DRUG)

not processed

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20
Q

container contain liquefied gas at extremely low temperature

A

CRYOGENIC VESSEL

contains nitrogen gas

21
Q

container contain gas ag a high pressure

A

CYLINDER

22
Q

Departure from an approved instruction or established standard

A

DEVIATION

23
Q

e dosage form in the final immediate packaging intended for marketing

A

DRUG PRODUCT

synonymous with FINISHED PRODUCT

24
Q

Any constituent other than the active substance and the packaging material

A

EXCIPIENT

25
Q

date placed on the container/labels which the API is expected to remain within established shelf-life specifications if store under defined conditions

A

EXPIRY DATE

Usually 2 years after manufacturing

26
Q

medicinal product which has undergone all stages of production, including packaging

A

FINISHED PRODUCT

Synonymous with DRUG PRODUCT

27
Q

Medicinal product exclusively plant material and /or
vegetable drug preparation

A

HERBAL MEDICINAL PRODUCT

28
Q

Any component presentnot the desired entity

A

IMPURITY

29
Q

Any substance or combination of substances for treating or preventing disease

A

MEDICINAL PRODUCT

DRUG

30
Q

All operations of filling and labelling of bulk product has to undergo in order to become a finished product

A

PACKAGING

includes inserts

31
Q

material employed in the packaging of a medicinal product excluding any outer packaging used for transportation or shipment

A

PACKAGING MATERIAL

only primary or secondary packaging material

32
Q

Description of the operations to be carried out, the precautions, measures to be applied to manufacture of a medicinal product

A

PROCEDURES

33
Q

All operations involved in the preparation of a medicinal product from receipt of materials to its completion as a finished product

A

PRODUCTION

34
Q

organized arrangements made with the objective of ensuring quality required and quality systems are maintained.

A

QUALITY ASSURANCE

35
Q

Checking or testing that specifications are met.

A

QUALITY CONTROL

Branch of QUALITY ASSURANCE

36
Q

status of isolation of materials whilst awaiting a decision on their release or refusal

A

QUARANTINE

37
Q

general term used to denote starting materials

A

RAW MATERIAL

Synonymous with STARTING MATERIAL

38
Q

voluntary removing or correcting products protect the public health and wellbeing

A

RECALL

39
Q

comparison between theoretically and actually produced or used in allowance for normal variations

A

RECONCILIATION

40
Q

substance with extensive set of analytical tests to be authentic material of high purity

A

REFERENCE STANDARD

typically for API

41
Q

reworking of all or part of a batch of an unacceptable quality from a defined stage of production rendered acceptable by one or more additional operations.

A

REPROCESSING

42
Q

Sending back to the manufacturer or distributor may or may not present a quality defect

A

RETURN

term for customers

43
Q

liquid used as a vehicle for the preparation

A

SOLVENT

44
Q

list of tests, references to analytical procedures, appropriate acceptance criteria

A

SPECIFICATION

45
Q

Any substance used in the production

A

STARTING MATERIAL

Synonymous with RAW MATERIAL

46
Q

absence of living organisms

A

STERILITY

Aseptic

47
Q

Action of proving, in accordance with the principles of Good Manufacturing Practice

A

VALIDATION

48
Q

anticipated quantity of material or the percentage of theoretical yield

A

YIELD, EXPECTED

49
Q

that would be produced at any appropriate phase of production in the absence of any loss or error

A

YIELD, THEORETICAL

Manufacturing Pharm (2 decks)

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