Terminologies (A-D)

Question 1

• The specifications and acceptance/rejection criteria, such as acceptable quality level and unacceptable quality level, with an associated sampling plan that are necessary for making a
  decision to accept or reject a lot or batch of raw material, intermediate, packaging material, or active pharmaceutical ingredient.
• This term can also be applied to validation

Answer 1

Acceptance Criteria

Question 2

The Federal Food and Drug Cosmetic Act as amended

Answer 2

Act

Question 3

The quantity that is actually produced at any appropriate phase of manufacture, processing, or packing of a particular API or intermediate

Answer 3

Actual yield

Question 4

• Any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to the structure or any
  function of the body of man or other animals.
• The term includes those components that may undergo chemical change in the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specific activity or effect

Answer 4

Active Ingredient

Question 5

• Any substance that is represented for use in a drug and that, when used in the manufacturing, processing, or packaging of a drug, becomes an active ingredient or a finished dosage form of the drug
• Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease, or to affect the structure and function of the body of humans or other animals

Answer 5

Active Pharmaceutical Ingredient

Question 6

APIs include substances manufactured by processes:

Answer 6

✓ Chemical synthesis
✓ Fermentation
✓ Recombinant DNA or other
biotechnology methods
✓ Isolation/ recovery from natural
sources
✓ Any combination of these processes

Question 6

The United States Food and Drug Administration

Answer 6

Agency

Question 6

The process by which it is established, by laboratory studies, that the performance characteristics of the method meet the requirements for the intended analytical applications

Answer 6

Analytical method validation

Question 7

• Once a country’s regulatory authority (for example, the Food and Drug Administration in the US) approve a new drug application, the new medicine becomes available for physicians to prescribe
• The manufacturing company must continue to submit periodic reports to the regulatory authority, including any cases of adverse reactions and appropriate quality control records
• For some medicines, the regulatory authority may require additional studies to evaluate long-term
  effects

Answer 7

Approval

Question 8

• A specific quantity of an intermediate or API intended to have uniform character and quality, within specific limits, and produced according to a single manufacturing order during the same cycle of manufacture.
• May also mean a specific quantity of material or API processed in one process or series of processes so that it could be expected to be homogenous

Answer 8

Batch

Question 9

A material originating from a biological manufacturing process intended to furnish pharmacological activity or other direct effect in the cure, treatment, or prevention of disease or
conditions of human being

Answer 9

Biologic active pharmaceutical ingredient

Question 10

Any virus, therapeutic serum, toxin, antitoxin, or analogous product applicable to prevention, treatment, or conditions of human beings

Answer 10

Biologic product

Question 11

A drug that is sold under the unique, trademarked name selected by the manufacturer rather than under its chemical name

Answer 11

Brand-name drug

Question 12

The demonstration that a particular instrument or device produces results within specified limits by comparison with those produced by a traceable standard over an appropriate range of measurements

Answer 12

Calibration

Question 13

A process that involves a chemical transformation of a starting material or intermediate to form a new compound (e.g. bond formation, oxidation, reduction)

Answer 13

Chemical reaction

Question 14

Any material used to clean process equipment, utensils, and storage vessels. These may include soaps, detergents, surfactants, alkalis, acids, or other materials, such as organic solvents, if the solvent is specifically used for cleaning and is not a solvent used in the next processing step

Answer 14

Cleaning Agent

Question 15

Clean In Place is a method of cleaning installed pipe and equipment without having to dismantle or move the pipe and equipment. However, provisions should be made for partial disassembly or for personnel access for purposes of cleaning
validation to facilitate inspection and sampling of inner product surfaces for possible residue or contaminates

Answer 15

CIP

Question 16

Denotes the symptoms and course of a disease as distinguished from the laboratory findings or anatomical changes.

Answer 16

Clinical

Question 17

Experienced clinical researcher who implements a clinical study protocol with patients.

Answer 17

Clinical investigator

Question 18

One who has undergone training in basic pharmacology of therapeutic agents in the prevention, treatment and control of disease in man

Answer 18

Clinical pharmacologist

Question 19

Any response by a patient to therapy. A positive response can be either complete, in which all signs or symptoms of the disease improve or partial, in which at least one half of the signs or symptoms of a disorder improve and no new signs appear.

Answer 19

Clinical response

Question 20

Testing in which preventive, diagnostic, or therapeutic agents are given to a human population under controlled conditions to
determine the agents’ safety and effectiveness.

This systematic investigation tests the effects of materials or methods, according to a formal study plan (that is, a protocol), usually in subjects having a particular disease or class of diseases. These trials are conducted to satisfy the regulatory requirements to obtain marketing approval for a
new drug or for a new indication for a drug previously approved for marketing. In the United
States, must be under an approved investigational
new drug application, under the guidance of an Institutional Review Board, and in accordance with the Food and Drug Administration’s (FDA) rules on
human studies and informed consent of participants.

These studies are conducted in three phases: Phase I, Phase II and Phase III.

Answer 20

Clinical trial or clinical study

Question 21

Can be subdivided into three major activities; installation, operation and performance qualifications. It is a formal, written procedure to the planning, executing and documenting of facility validation. This process may include
environmental compliance checks, verification of personnel protection equipment and qualification of containment systems as well as validation of systems related to cGMP regulations.

Answer 21

Commissioning

Question 22

Any ingredient intended for use in the manufacture of a drug product, including those that may not appear in such drug product.

Answer 22

Component

Question 23

A subset of prospective validation in which API batches are released for distribution, based on extensive testing, before completion of process validation. Once data from additional batches produced under replicated conditions show uniformity, the process may be considered validated.

Answer 23

Concurrent validation

Question 24

Achieving a level of control over a raw material, intermediate, or API that provides proper protection of these materials from external contamination and cross-contamination.

Answer 24

Containment

Question 25

The introduction of impurities of a chemical or microbiological nature, or of foreign matter, into or onto a raw material, intermediate, or API (e.g., occurring during production, sampling, packaging or repackaging, storage or transport).

Answer 25

Contamination

Question 26

A process in which a material is continuously produced in a step or series of steps. In a continuous process, the batches of raw materials and the process parameters can be statistically, but not absolutely, correlated to the material produced in a given period of time.

Answer 26

Continuous production

Question 27

Clinical testing in which one group of subjects is used as a standard of comparison to determine the usefulness of a new medical approach. In a controlled study, doctors give the new drug being tested to one group of subjects, called the “treatment group.” They give another drug, or no drug, to a second group of people under the same conditions. This group is often called the “control group.” Researchers then compare the results of the two groups

Answer 27

Controlled study or controlled trial

Question 28

Process parameters that must be controlled within established operating ranges to ensure that the API or intermediate will meet specifications for quality and purity.

Answer 28

Critical process parameters

Question 29

Process steps that must be controlled within established operating ranges to ensure that the API or intermediate will meet specifications for quality and purity

Answer 29

Critical process steps

Question 30

A contamination of a material or product with another material or product.

Answer 30

Cross-contamination

Question 31

A report that summarizes the major stages of API development from early stages through large scale manufacturing.

Answer 31

Development report

Question 32

The form in which a drug is produced. Pharmaceutical companies use many methods of drug delivery, including oils, gels, creams and sprays; capsules and tablets; injects; implants; suppositories; and liquids and syrups.

Answer 32

Dosage formulation

Question 33

Amount of active drug contained in a particular formulation; for example 50, 100, or 500 milligrams. double-blind study: A scientific study in which neither the subject (patients) nor the investigators (treating physicians) know who is receiving the experimental treatment and who is receiving a placebo (a control or “sugar pill”).

Answer 33

Dosage strength

Question 34

As defined in Section 201(g)(1) of the Act means
(a) articles that are recognized in the official United
States Pharmacopeia, official Homeopathic Pharmacopeia of the United States, or official
National Formulary, or any supplement to them;
(b) articles intended for use in the diagnosis, cure,
mitigation, treatment, or prevention of disease in
humans or other animals; and articles (other than
food) intended to affect the structure or any function of the body of humans or other animals

Answer 34

Drug

Question 35

The process by which a formulated drug is administered to the patient. Traditional methods have been orally or by injection. Newer methods include through the skin by application of a transdermal patch, or across the nasal membrane by administration of a specially formulated nasal
spray.

Answer 35

Drug delivery

Question 36

Modification of the effect of one drug by another in a way that diminishes, negates or enhances the effectiveness or safety of one or both drugs.

Answer 36

Drug interaction

Question 37

A finished dosage form, for example, a tablet, capsule or solution, that contains an active pharmaceutical ingredient, generally, but not necessarily, in association with inactive ingredients. The term also includes a finished dosage form that does not contain an API but is intended to be used as a placebo

Answer 37

Drug product