Terminologies (Q-W)

Question 1

The action of proving that any equipment or process works correctly and consistently and produces the expected results. Qualification is part
of, but not limited to, a validation process, i.e., installation qualification (1Q), operation qualification (OQ), and performance qualification (PQ).

Answer 1

Qualification

Question 2

A Qualification Protocol (QP) is a written plan or procedure stating in sufficient detail how qualification will be achieved. Included are specific qualification requirements for each equipment
item, each system requirement, and product requirement. Each protocol should stipulate test parameters as well as decision points on what constitutes acceptable test results. The written
protocols should be based on the associated qualification procedures and should be step-by-step instructions to be used in the field to qualify equipment, instruments, materials, systems and subsystems, and should include data sheets to record critical data.

Answer 2

Qualification Protocol

Question 3

The sum total of the organized activities performed with the intent to ensure that all APIs are of the quality required for their intended use.

Answer 3

Quality Assurance (QA)

Question 4

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

Answer 4

Quality Control (QC)

Question 5

The status of materials isolated physically or by other effective means pending a decision on their subsequent use.

Answer 5

Quarantine

Question 6

Arithmetic mean roughness value. The
arithmetical average of all absolute distances of the roughness profile R from the center line within the measuring length lm.

Answer 6

Ra (CLA)

Question 7

root mean square roughness value. (An
alternative to Ra.) The RMS value of a profile calculated over a single sampling length, but can be expressed as the mean result of 5 consecutive sampling lengths.

Answer 7

Rq (RMS)

Question 8

The range for each process parameter generally developed on laboratory-, pilot-, or plant-scale batches that encompasses values that are capable of producing intermediates and APIs
having acceptable quality attributes.

Answer 8

Range for critical process parameter

Question 9

Any ingredient intended for use in the production of APIs. These may include starting materials, process aids, solvents, and reagents.

Answer 9

Raw material

Question 10

A substance, other than a starting material or solvent, that is used in the manufacture of an API or intermediate

Answer 10

Reagent

Question 11

Any treatment of materials by a process intended to make them suitable for further use.

Answer 11

Recovery

Question 12

Adding fresh reagents or solvents to unreacted or base material and repeating a chemical reaction from its beginning. This excludes those situations where a chemical reaction is continued or extended in the same vessel with the addition of more solvent, to ensure completion of a reaction or increase the yield and/or purity of the API (e.g., continuation of a hydrogenation step).

Answer 12

Repeating a chemical reaction

Question 13

A sample that consists of a number of units that are drawn based on rational criteria such as random sampling and intended to assure that the sample accurately portrays the material being
sampled.

Answer 13

Representative sample

Question 14

Introducing an intermediate or API that does not conform to standards or specifications, back into the process and repeating one or more steps that
are part of the established manufacturing process (e.g., recrystallization using the same solvent).

Answer 14

Reprocessing

Question 15

The date when the API should be re-examined to ensure that it is still suitable for use.

Answer 15

Retest date

Question 16

The period of time during which the API can be considered to remain within specifications, and therefore acceptable for use in the manufacture of a given drug product, provided that it has been
stored under defined conditions. After this period, the API should be retested for compliance with specifications before use.

Answer 16

Retest period

Question 17

One of three forms of evaluation of prescribing patterns to specifically determine the appropriateness of drug therapy. Retrospective drug use evaluation is conducted after the therapy has been completed. There are two other forms of drug use evaluation: concurrent (during the course of drug therapy) and prospective (before or at the time of dispensing).

Answer 17

Retrospective concurrent drug use evaluation

Question 18

Establishing documented evidence that a system does what it purports to do based on a review and analysis of historic information. It is normally conducted on an API already being commercially distributed and is based on accumulated production, testing, and control data.

Answer 18

Retrospective validation

Question 19

Subjecting an intermediate or API that does not conform to standards or specifications, to one or more processing steps that are different from the established manufacturing process (e.g., recrystallizing with a different solvent).

Answer 19

Risk-benefit ratio

Question 20

An abbreviation of the Latin word “recipere” which means “to take”. The symbol is used at the beginning of a medical prescription

Answer 20

Rx

Question 21

Secondary and usually adverse effect, as from a drug or other treatment. For example, nausea is a side effect of some anticancer drugs.

Answer 21

Side effect

Question 22

A study in which one party (either the patient or investigator) is unaware of what medication the patient is taking.

Answer 22

Single-blind study

Question 23

Any liquid used as a vehicle for the preparation of solutions or suspensions in the synthesis of an API or intermediate.

Answer 23

Solvent

Question 24

A material used in the synthesis of an API, which is incorporated as an element into the structure of an intermediate and/or of the API. Starting
materials are normally commercially available and of defined chemical and physical properties and structure.

Answer 24

Starting material

Question 25

(i) The concentration of the drug substance ( for example, weight/weight, weight/volume, or unit
dose/volume basis) and/or,

(ii) The potency, that is, the therapeutic activity of the drug product as indicated by appropriate laboratory tests or by
adequately developed and controlled clinical data (expressed, for example, in terms of units by reference to a standard).

Answer 25

Strength

Question 26

Patients in clinical trials are assigne to one part or segment of a study – a study “arm”. One arm receives a different treatment from another.

Answer 26

Study arm

Question 27

System Qualification (SQ) consists of the IQ/OQ documentation pertaining to all equipment, instruments, materials and subsystems within a specific system or unit operation, generally
identified by a single Piping & Instrument Flow Diagram (P&ID).

Answer 27

System Qualification

Question 28

Group of drugs intended to treat or cure a particular disease or related diseases. Several of these categories are antibiotics (drugs that prevent, inhibit or destroy microorganisms), cardiovascular (drugs that treat diseases of the heart and blood vessels), hypnotics (drugs that
induce sleep), and nonsteroidal anti-inflammatory drugs or NSAIDs (drugs used to treat pain, fever and swelling)

Answer 28

Therapeutic category

Question 29

The quantity that would be produced at any appropriate phase of manufacture, processing, or packing of a particular API or intermediate, based upon the quantity of components to be used, in the absence of any loss or error in actual production

Answer 29

Theoretical yield

Question 30

Impurities having significant undesirable biological activity. toxicology: Scientific discipline concerning the identification and effects of poisons and the
treatment of poisoned individual.

Answer 30

Toxic impurity

Question 31

Group of tests to determine the potential risk of a compound to man and the environment. These studies involve the use of animals, tissue cultures and other test systems to examine dose level, frequency of administration, and duration on the dose-response pattern of the compound and its toxic side effects. Most toxicology and safety
testing is conducted before its human introduction

Answer 31

Toxicology safety and testing

Question 32

A measure of total prescriptions (new and refills) issued in a given time period.

Answer 32

TRx

Question 33

An impurity that is defined solely by qualitative analytical properties (e.g., chromatographic retention time).

Answer 33

Unidentified impurity

Question 34

The procedure for establishing documented evidence that a specific system or facility is constructed and operates according to a predetermined set of specifications and guidelines.

Answer 34

Validation

Question 35

A written plan stating how validation will be conducted while identifying specific acceptance criteria. For example, the protocol for a typical manufacturing process identifies processing equipment, critical process parameters/operating ranges, product characteristics, sampling and test
data to be collected, number of validation runs, and acceptable test results.

Answer 35

Validation protocol

Question 36

An API, intermediate or other substance of established quality and purity, as shown by comparison to a primary reference standard, used as a reference for routine laboratory analysis

Answer 36

Working standard