Ch3- GMP Definitions

Question 1

Active ingredient or active pharmaceutical
ingredient (API):

Answer 1

Any component that is
intended to furnish pharmacologic 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.

Question 2

Batch:

Answer 2

A specific quantity of a drug of uniform
specified quality produced according to a
single manufacturing order during the same
cycle of manufacture.

Question 3

Batchwise control:

Answer 3

The use of validated in-process sampling and testing methods in such a way that results prove that the process has done what it purports to do for the specific batch concerned.

Question 4

Certification:

Answer 4

Documented testimony by qualified authorities that a system qualification, calibration, validation, or revalidation has been performed appropriately and that the results are acceptable.

Question 5

Compliance:

Answer 5

Determination through inspection of the extent to which a manufacturer is acting in accordance with prescribed regulations, standards, and practices.

Question 6

Component:

Answer 6

Any ingredient used in the manufacture of a drug product, including those that may not be present in the finished product.

Question 7

Drug product:

Answer 7

A finished form that contains an active drug and inactive ingredients. The term may also include a form that does not contain an active ingredient, such as a placebo.

Question 8

Inactive ingredient:

Answer 8

Any component other than the active ingredients in a drug product.

Question 9

** Lot:**

Answer 9

A batch or any portion of a batch having uniform specified quality and a distinctive identifying lot number.

Question 10

Lot number, control number, or batch number:

Answer 10

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 a drug product may be determined.

Question 11

Master record:

Answer 11

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

Question 12

Quality assurance:

Answer 12

Provision to all concerned the evidence needed to establish confidence that the activities relating to quality are being performed adequately.

Question 13

Quality audit:

Answer 13

A documented activity performed in accordance with established procedures on a planned and periodic basis to verify compliance with the procedures to ensure quality.

Question 14

Quality control:

Answer 14

The regulatory process through which industry measures actual quality
performance, compares it with standards, and acts on the difference.

Question 15

Quality control unit:

Answer 15

An organizational element designated by a firm to be responsible for the duties relating to quality control.

Question 16

Quarantine:

Answer 16

** An area that is marked, designated, or set aside for the holding of incoming components prior to acceptance testing and qualification for use.**

Question 17

Representative sample:

Answer 17

A sample that accurately portrays the whole.

Question 18

Reprocessing:

Answer 18

The activity whereby the finished product or any of its components is recycled through all or part of the manufacturing process.

Question 19

Strength:

Answer 19

The concentration of the drug substance
per unit dose or volume.

Question 20

Verified:

Answer 20

Signed by a second individual or recorded by automated equipment.

Question 21

Validation:

Answer 21

Documented evidence that a system (e.g., equipment, software, controls) does what it purports to do.

Question 22

Process validation:

Answer 22

Documented evidence that a process (e.g., sterilization) does what it purports to do.

Question 23

Validation protocol:

Answer 23

A prospective experimental plan to produce documented evidence that the system has been validated.

Question 24

Name

Any component that is
intended to furnish pharmacologic 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 24

Active ingredient or active pharmaceutical
ingredient (API):

Question 25

Name

A specific quantity of a drug of uniform
specified quality produced according to a
single manufacturing order during the same
cycle of manufacture.

Answer 25

Batch:

Question 26

Name

The use of validated in-process sampling and testing methods in such a way that results prove that the process has done what it purports to do for the specific batch concerned.

Answer 26

Batchwise control:

Question 27

Name

Documented testimony by qualified authorities that a system qualification, calibration, validation, or revalidation has been performed appropriately and that the results are acceptable.

Answer 27

Certification:

Question 28

Name

Determination through inspection of the extent to which a manufacturer is acting in accordance with prescribed regulations, standards, and practices.

Answer 28

Compliance:

Question 29

Name

Any ingredient used in the manufacture of a drug product, including those that may not be present in the finished product.

Answer 29

Component:

Question 30

Name

A finished form that contains an active drug and inactive ingredients. The term may also include a form that does not contain an active ingredient, such as a placebo.

Answer 30

Drug product:

Question 31

Name

Any component other than the active ingredients in a drug product.

Answer 31

Inactive ingredient:

Question 32

Name

A batch or any portion of a batch having uniform specified quality and a distinctive identifying lot number.

Answer 32

** Lot:**

Question 33

Name

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 a drug product may be determined.

Answer 33

Lot number, control number, or batch number:

Question 34

Name

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

Answer 34

Master record:

Question 35

Name

Provision to all concerned the evidence needed to establish confidence that the activities relating to quality are being performed adequately.

Answer 35

Quality assurance:

Question 36

Name

A documented activity performed in accordance with established procedures on a planned and periodic basis to verify compliance with the procedures to ensure quality.

Answer 36

Quality audit:

Question 37

Name

The regulatory process through which industry measures actual quality
performance, compares it with standards, and acts on the difference.

Answer 37

Quality control:

Question 38

Name

An organizational element designated by a firm to be responsible for the duties relating to quality control.

Answer 38

Quality control unit:

Question 39

Name

** An area that is marked, designated, or set aside for the holding of incoming components prior to acceptance testing and qualification for use.**

Answer 39

Quarantine:

Question 40

Name

A sample that accurately portrays the whole.

Answer 40

Representative sample:

Question 41

Name

The activity whereby the finished product or any of its components is recycled through all or part of the manufacturing process.

Answer 41

Reprocessing:

Question 42

Name

The concentration of the drug substance
per unit dose or volume.

Answer 42

Strength:

Question 43

Name

Signed by a second individual or recorded by automated equipment.

Answer 43

Verified:

Question 44

Name

Documented evidence that a system (e.g., equipment, software, controls) does what it purports to do.

Answer 44

Validation:

Question 45

Name

Documented evidence that a process (e.g., sterilization) does what it purports to do.

Answer 45

Process validation:

Question 46

Name

A prospective experimental plan to produce documented evidence that the system has been validated.

Answer 46

Validation protocol: