Unit 1 Terms

Question 1

Contaminated with extraneous biological agents and capable of spreading infection

Answer 1

INFECTED

Question 2

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

Answer 2

IN-PROCESS CONTROL

Question 3

Partly processed material which must undergo further manufacturing

Answer 3

INTERMEDIATE PRODUCT

before bulk product

Question 4

All operations

Answer 4

MANUFACTURE

Question 5

company holding a “manufacturing authorization”

Answer 5

MANUFACTURER

Question 6

Whole plant or part which is used for medicinal purposes

Answer 6

MEDICINAL PLANT

processed

Question 7

Substances that give its therapeutic effect

Answer 7

ACTIVE PHARMACEUTICAL INGREDIENT (API)

“Active Substance” or “Drug Substance.”

Question 8

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.

Answer 8

AIRLOCK

Anteroom

Question 9

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

Answer 9

BATCH (or LOT)

Question 10

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

Answer 10

BATCH NUMBER (or LOT NUMBER)

Question 11

Microorganisms, whether pathogenic or not

Answer 11

BIOLOGICAL AGENTS

Question 12

product which has completed processing stages but not including final packaging

Answer 12

BULK PRODUCT

Question 13

area with defined environmental control of particulate and microbial contamination

Answer 13

CLEAN AREA

whole area in general

Question 13

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

Answer 13

CALIBRATION

Question 14

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

Answer 14

CONTAINED AREA

specific room
synonymous with CONTAINMENT

Question 15

confining a biological agent or other entity within a defined space

Answer 15

CONTAINMENT

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

Question 16

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

Answer 16

CONTAINED AREA

strictest area

Question 17

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

Answer 17

COMPUTERIZED SYSTEM

Question 18

Contamination with another material or product.

Answer 18

CROSS-CONTAMINATION

Question 19

Fresh or dried medicinal plant or parts

Answer 19

CRUDE PLANT

(VEGETABLE DRUG)

not processed

Question 20

container contain liquefied gas at extremely low temperature

Answer 20

CRYOGENIC VESSEL

contains nitrogen gas

Question 21

container contain gas ag a high pressure

Answer 21

CYLINDER

Question 22

Departure from an approved instruction or established standard

Answer 22

DEVIATION

Question 23

e dosage form in the final immediate packaging intended for marketing

Answer 23

DRUG PRODUCT

synonymous with FINISHED PRODUCT

Question 24

Any constituent other than the active substance and the packaging material

Answer 24

EXCIPIENT

Question 25

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

Answer 25

EXPIRY DATE ## Footnote Usually 2 years after manufacturing

Question 26

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

Answer 26

FINISHED PRODUCT ## Footnote Synonymous with DRUG PRODUCT

Question 27

Medicinal product exclusively plant material and /or vegetable drug preparation

Answer 27

HERBAL MEDICINAL PRODUCT

Question 28

Any component presentnot the desired entity

Answer 28

IMPURITY

Question 29

Any substance or combination of substances for treating or preventing disease

Answer 29

MEDICINAL PRODUCT | DRUG

Question 30

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

Answer 30

PACKAGING ## Footnote includes inserts

Question 31

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

Answer 31

PACKAGING MATERIAL ## Footnote only primary or secondary packaging material

Question 32

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

Answer 32

PROCEDURES

Question 33

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

Answer 33

PRODUCTION

Question 34

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

Answer 34

QUALITY ASSURANCE

Question 35

Checking or testing that specifications are met.

Answer 35

QUALITY CONTROL ## Footnote Branch of QUALITY ASSURANCE

Question 36

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

Answer 36

QUARANTINE

Question 37

general term used to denote starting materials

Answer 37

RAW MATERIAL ## Footnote Synonymous with STARTING MATERIAL

Question 38

voluntary removing or correcting products protect the public health and wellbeing

Answer 38

RECALL

Question 39

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

Answer 39

RECONCILIATION

Question 40

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

Answer 40

REFERENCE STANDARD ## Footnote typically for API

Question 41

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.

Answer 41

REPROCESSING

Question 42

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

Answer 42

RETURN ## Footnote term for customers

Question 43

liquid used as a vehicle for the preparation

Answer 43

SOLVENT

Question 44

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

Answer 44

SPECIFICATION

Question 45

Any substance used in the production

Answer 45

STARTING MATERIAL ## Footnote Synonymous with RAW MATERIAL

Question 46

absence of living organisms

Answer 46

STERILITY | Aseptic

Question 47

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

Answer 47

VALIDATION

Question 48

anticipated quantity of material or the percentage of theoretical yield

Answer 48

YIELD, EXPECTED

Question 49

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

Answer 49

YIELD, THEORETICAL