GMP Requirements--terms

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 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

drug product

Answer 6

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 7

inactive ingredient

Answer 7

Any component other than the active ingredients in a drug product

Question 8

lot

Answer 8

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

Question 9

lot number, control number, or batch number

Answer 9

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 10

master record

Answer 10

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

Question 11

quality assurance

Answer 11

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

Question 12

component

Answer 12

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

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 (i.e. equipment, software, controls) does what it purports to do

Question 22

process validation

Answer 22

Documented evidence that a process (i.e. 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

quality control unit

Answer 24

Any person or organizational element designated by the firm to be responsible for the duties relating to quality control

Question 25

theoretical yield

Answer 25

Quantity that would be produced at any appropriate phase of manufacture, in the absence of any loss or error

Question 26

actual yield

Answer 26

Quantity that is actually produced at any appropriate phase of manufacture