Terminologies (E-I)

Question 1

Measure of the therapeutic effectiveness of a drug

Answer 1

Efficacy

Question 2

The electrochemical method of removing metal (usually stainless steel) from a surface. More specifically, it is the anodic dissolution of metal in the presence of an electrolyte and an imposed current potential. This process creates a
continuous film of chromium rich oxide on the affected surface.

Answer 2

Electropolishing

Question 3

The resulting film from electropolishing provides the
following benefits:

Answer 3

1. It provides an excellent passive barrier between the body of the material (i.e. internal or external pipe wall) and the contained fluid, or external environment, enhancing corrosion resistance.
2. Provides for improved cleanability and sterilization aspects
3. Allows for improved quality control by exposing defects in welds and base material.
4. Avoids the surface tension caused when mechanical polishing is used.

Question 4

Key facts about a person’s health that make a patient right, or not right, for a certain research study. Examples of these facts include: a person’s age, what symptoms of the illness he or she has, results of certain laboratory tests, a person’s
overall health, and past treatments. Both the “must-have” and the “can’t-have” check lists help doctors get clear research results about whom a new drug will help, not help, or harm.

Answer 4

Eligibility criteria

Question 5

Compounds with the same molecular formula as the API, which differ in the spatial arrangement of atoms within the molecule and are non superimposable mirror images

Answer 5

Enantiomers

Question 6

A drug that primarily sold only through physicians and pharmacists, rather through direct selling to customers. Sometimes referred to as a “prescription-only” drug

Answer 6

Ethical drug

Question 7

The quantity of API or intermediate or the percentage of theoretical yield anticipated at any appropriate phase of production based on data from process development or process validation

Answer 7

Expected yield

Question 8

The date (usually placed on the containers/labels of an API) designating the time during which the API is expected to remain within established shelf-life specifications if stored under defined conditions and alter which it should not be used

Answer 8

Expiry/expiration date

Question 9

An impurity arising from any source extraneous to the manufacturing process

Answer 9

Extraneous substance

Question 10

Any particulate contaminant with a length at least three times greater than its width.

Answer 10

Fiber

Question 11

Labeling derived from a sheet of material on which more than one item of labeling is printed

Answer 11

Gang-printed labelling

Question 12

A broad term for chemically equivalent drugs that are available from multiple manufacturers. Commonly used to refer to products, other than then innovators, that are sold under the universal chemical name for the drug

Answer 12

Generic drug

Question 13

(current) Good Manufacturing Practice as put forth in various guidelines through the combined efforts of the FDA, U.S. Department of Health and Human Services, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER) and Center for Veterinary
Medicine (CVM). These guidelines, without providing specific methodology, identify the expectations of the FDA in regard to the design, construction and operation of facilities intended for the manufacturing, processing, packing or holding of API’s.

Answer 13

GMP (cGMP)

Question 14

In reference to the polishing of stainless-steel pipe: Grit is one method of determining or specifying a degree of smoothness or surface roughness required. Initially a desired smoothness for the inside or outside of pipe was specified in polish numbers such as #4 or #7. However, this system of specifying surface roughness provided for too broad a range of roughness. Grit numbers have essentially replaced polish numbers in an effort at providing more specific requirements.

Answer 14

Grit

Question 15

a #4 polish could vary from an__________
a #7 polish could vary from a ___________

Answer 15

80 grit to a 150-grit finish
180 grit to a 320-grit finish

Question 16

The industry is now adopting an even more specific method of determining surface roughness. The surface is specified in micro inches or microns and measured with a _________.

Answer 16

Profilometer

Question 17

The surface roughness is measured or specified as either of two arithmetic derivations

Answer 17

Rq – root mean square or Ra –arithmetic mean.

Question 18

An impurity for which a structural characterization has been achieved.

Answer 18

Identified impurity

Question 19

Any component of an API that is not the entity defined as the API.

Answer 19

Impurity

Question 20

A description of the identified and unidentified impurities present in an API

Answer 20

Impurity profile

Question 21

Any component other than an “active ingredient”.

Answer 21

Inactive ingredient

Question 22

Treatments that a drug will address. Approved indications are those that government regulators have accepted based on clinical testing. Only these indications may be marketed and offered for sale to the public, although physicians may prescribe drugs for unapproved indications according to their professional judgment

Answer 22

Indications

Question 23

The process by which patients learn about and document their understanding of the purpose and procedures of a clinical trial and their agreement to participate in that trial.

Answer 23

Informed consent

Question 24

Testing and activities performed during production to monitor and, if necessary, adjust the process.

Answer 24

In-process controls

Question 25

Any material manufactured, blended, or derived by chemical reaction that is produced for, and used in, the preparation of an API.

Answer 25

In-process material

Question 26

Establishing confidence that process equipment and ancillary systems are capable of consistently operating within established limits and tolerances.

Answer 26

Installation Qualification

Question 27

A group of doctors, science experts, clergy and others who review and approve the performance of each clinical study at their institution. Each hospital doing the research must have a review board. This board makes sure that the study protects patient safety in light of the potential benefit that it may bring. IRB is the term used in the United States, but the committee is more frequently referred to as an “ethics committee” in other markets.

Answer 27

Institutional Review Board (IRB)

Question 28

A material produced during steps in the synthesis of an API that must undergo further molecular change or processing before it becomes an API.

Answer 28

Intermediate

Question 29

ISO

Answer 29

International Standards Organization

Question 30

The document that a sponsor (usually a drug company) must submit to the FDA before beginning testing of a new drug on humans. This IND application contains the plans for the clinical for the clinical studies and gives a complete picture
of the drug, including its structural formula, animal test results, and manufacturing information. The IND application contains information resulting from several years of research and testing.

Answer 30

Investigational New Drug (IND) application

Question 31

In glass

Answer 31

In vitro

Question 32

Latin phrase meaning “in the body”. Referring to a biological process or experiment occurring or carried out in the living organism. In vivo studies are carried in animals or humans. J No terms under ‘J’ K No terms under ‘K’

Answer 32

In vivo