Glossary

Question 1

Define: Accuracy

Answer 1

the degree to which the result of a measurement, calculation, or specification conforms to the correct value or a standard.

Question 2

Define: Action Level

Answer 2

Specification or limit (in fact, more correctly called an action limit rather than an action level) established in published regulation (or a guidance or guideline or standard that is regarded by competent authorities as de facto regulation) that, when exceeded, requires immediate intervention, including investigation of cause, immediate remediation, and/or corrective action.

Question 3

Define: Active Ingredient

Answer 3

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 affect 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 specified activity or effect.

Question 4

Define: Actual Yield

Answer 4

The quantity that is actually produce at any appropriate phase of manufacture, processing, or packing of a particular drug product.

Question 5

Define: Adulterated

Answer 5

Violative state of a drug or device as described in Section 501, “______ Drugs and Devices,” of the Food, Drug, and Cosmetic Act (FDCA). Any of the following are bases for ______-ation: (i) if it is a drug or device containing a filthy, putrid, or decomposed substance (that is, an animal part or insect) or manufactured under unsanitary conditions, or if the drug or device may have been rendered injurious to health; (ii) if it is a drug and the methods used in, or the facilities or controls used for, its manufacturing practice; (iii) if it is a drug recognized by the USP and its strength differs from, or its quality or purity falls below the standards set forth in the USP (unless exceptions are contained in the labeling); (iv) if it is a drug and any substance has been mixed or packed with it so as to reduce its quality or strength or substituted wholly or in part for the active pharmaceutical ingredient (for example, oversulfated chondroitin sulfate for heparin).

Question 6

Define: Aerosol Generator

Answer 6

Instrument capable of producing particulate matter in an appropriate particle size (for example, 0.05 to 2 micron).

Question 7

Define: Air Exchange Rate

Answer 7

Air changers per unit of time, which is calculated by dividing the volumetric flow rate of incoming air by the volume of the space/room.

Question 8

Define: Alert Level

Answer 8

Measurement magnitude set by an active pharmaceutical ingredient (API) or finished pharmaceutical manufacturer that gives early warning of a drift from normal conditions and that, when exceeded, should result in increased attention to the process.

Question 9

Define: Annual Review

Answer 9

An evaluation, conducted at least annually, that assesses the quality standards of each drug product to determine the need for changes in drug product specifications or manufacturing or control procedures.

Question 10

Define: Antisepsis

Answer 10

Act or process of chemically reducing viable organisms on living tissue, including ski, oral cavities, and open wounds.

Question 11

Define: As-Built

Answer 11

Occupancy state in which an installation is complete with all services connected and functioning but with no production equipment, materials, or personnel present.

Question 12

Define: Aseptic Processing Area (APA)

Answer 12

Controlled environments in which the air supply, materials, equipment, and personnel are regulated to control microbial and particulate numbers to acceptable levels.

Question 13

Define: Aseptic Technique

Answer 13

A technique requiring the use of various barriers to prevent the transfer of microorganisms and other contaminants from personnel and the environment to products being manufactured, inspected, labeled or packaged.

Question 14

Define: Assay

Answer 14

Qualitative or quantitative analysis of a drug to determine its components.

Question 15

Define: At Rest

Answer 15

Occupancy state in which an installation is complete with equipment installed and operating in a defined manner but with zero personnel present.

Question 16

Define: Audit

Answer 16

The on-site verification activity, such as inspection or examination,

Question 17

Define: Batch Number

Answer 17

Any distinctive combination of letters, numbers, or symbols from which the complete history of the manufacture, processing, packing, holding, and distribution of a batch or lot of drug product or other material can be determined.

Question 18

Define: Bioburden

Answer 18

The total quantity of recoverable microbes present on a defined surface or surface area, or within a nonsterile solid/powder or liquid drug, intermediate, or raw material.

Question 19

Define: Biological Product

Answer 19

A wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. Biologics can be composed of sugars, proteins, or nucleic acids, or complex combinations of these substances, or may be living entities such as cells and tissues.

Question 20

Define: Bulk Production Batch

Answer 20

A batch of product of a size described in the application for a marketing authorization, either ready for assembly into final containers or in individual containers ready for assembly into final packs. A bulk production batch may, for example, consist of a bulk quantity of liquid product, of solid dosage forms such as tablets or capsules, or of filled ampules.

Question 21

Define: Calibration

Answer 21

The comparison of a measurement instrument or system of unverified accuracy to a measurement instrument or system of known accuracy to detect any variation from the required performance specification.

Question 22

Define: Can

Answer 22

Indicates a possibility or a capability in regard to a standard.

Question 23

Define: Certification of the Finished Product Batch

Answer 23

Certification in a register or equivalent document by a European Union qualified person, as defined in Article 51 of Directive 2001/83/EC and Article 55 of Directive 2001/81/EC, before a batch is released for sale or distribution.

Question 24

Define: Change Control

Answer 24

A written procedure that describes the action to be taken if a change is proposed to facilities, materials, equipment, and/or processes used in fabrication, packaging, and testing of drugs, or that may affect the operation of the quality or support system.

Question 25

Define: Chiral

Answer 25

Not superimposable with its mirror image, as applied to molecules, conformations, and macroscopic objects, such as crystals. The term has been extended to samples of substances whos molecules are chiral, even in the macroscopic assembly of such molecules is racemic.

Question 26

Define: Chromatogram

Answer 26

A graphical or other representation of detector response, effluent concentration, or other quantity used as a measure of effluent concentration, versus time, volume, or distance. Idealized chromatograms are represented as a sequence of Gaussian peaks on a baseline.

Question 27

Define: Classification

Answer 27

Level (or process of specifying or determining the level) of airborne particulate cleanliness applicable to a cleanroom or clean zone, expressed in terms of an ISO Class N, which represents the maximum allowable concentrations (in particles per cubic meter of air) for considered sizes of particles (see ISO 14644-1).

Question 28

Define: Cleaning

Answer 28

Physical removal of soil, organic debris, and particulate from surfaces.

Question 29

Define: Cleaning Validation

Answer 29

Documented evidence with a high degree of assurance that a cleaning process will consistently yield product contact surfaces that meet predetermined acceptance criteria and critical quality attributes (visual and residual levels).

Question 30

Define: Cleanroom

Answer 30

A room that is maintained virtually free of contaminants, such as dust or bacteria, used in laboratory work and in the production of precision parts or electronic or aerospace equipment.

Question 31

Define: Combination Products

Answer 31

Therapeutic and diagnostic products that combine drugs, devices, and/or biological products.

Question 32

Define: Competent Authority

Answer 32

Country-specific agency or body designated to administer that country’s laws/statues governing the marketing of safe and effective drugs, medical devices, foods, dietary supplements, cosmetics, and so on. Enacts regulations, guidelines, guidance, and so on, in line with those statues/laws.

Question 33

Define: Component

Answer 33

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

Question 34

Define: Confirmation

Answer 34

Signed statement that a process or test has been conducted in accordance with GMP and the relevant marketing authorization, as agreed in writing with the qualified person (QP) responsible for certifying the finished product batch before release.

Question 35

Define: Conformity Assessment

Answer 35

Any activity performed to determine, directly or indirectly, that a process, product or service meets relevant technical standards and fulfills relevant requirements.

Question 36

Define: Contact Plate

Answer 36

A petri dish usually measuring 55mm in diameter containing convex-shaped agar that forms a dome above the dish to permit sampling of flat surfaces for microorganisms.

Question 37

Define: Contamination

Answer 37

The undesired introduction of impurities of a chemical or microbiological nature, or of foreign matter, into or onto a raw material intermediate, active pharmaceutical ingredient, finished drug, primary surface, or equipment.

Question 38

Define: Continual Improvement

Answer 38

Ongoing activities to evaluate and positively change products, processes, and the quality system to increase effectiveness.

Question 39

Define: Control Chart

Answer 39

A statistical tool including upper and lower control limits and the process average, which visually displays process performance.

Question 40

Define: Control Limits

Answer 40

The area three standard deviations on either side of the centerline, or mean, of data plotted on a control chart.

Question 41

Define: Control Strategy

Answer 41

Planned set of controls, derived from current product and process understanding, that assures process performance and product quality. The controls can include parameters and attributes related to drug substance and drug product materials and components, facility and equipment operating conditions, in-process controls, finished product specifications, and the associated methods and frequency of monitoring and control.

Question 42

Define: Controlled Area

Answer 42

A non-classified room or operating area designed to control/minimize the presence, proliferation, and/or ingress of particulates, and in directional airflow, and viable and nonviable particulate limits) are defined and monitored to prevent contamination of exposed products.

Question 43

Define: Corrective Action

Answer 43

Action taken to eliminate the causes of an existing discrepancy or other undesirable situation to prevent recurrence.

Question 43

Define: Correction

Answer 43

Repair, rework, or adjustment relating to the disposition of an existing discrepancy (also called remedy, remediation); usually the first step in a corrective action.

Question 44

Define: Critical Area

Answer 44

An area in which the sterilized drug product, containers, and closures are exposed to environmental conditions that must be designed to maintain product sterility.

Question 45

Define: Critical Process Parameter (CPP)

Answer 45

Quantifiable equipment setting whose variability has an impact on a critical quality attribute and therefore should be monitored or controlled to ensure that the process produces the desired quality, purity, potency, and safety.

Question 46

Define: Critical Quality Attribute (CQA)

Answer 46

Physical, chemical, biological, or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality.

Question 47

Define: Customer

Answer 47

Person or organization (internal or external) that receives a product or service anywhere along the product’s life cycle.

Question 48

Define: Decision Maker(s)

Answer 48

Person(s) with the competence and authority to make appropriate and timely quality risk management decisions.

Question 49

Define: Design of Experiements (DOE)