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cGMP Definition of Terms Flashcards

1
Q

The nearest value obtained during measurement or analysis to the true value.

A

Accuracy

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2
Q

The quantity that is actually produced at any phase of production of a particular
drug product based on the initial input.

A

Actual Yield

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3
Q

An enclosed space with two or more doors, which is interposed between two or more rooms e.g. of different standard of cleanliness for the purpose of controlling the air flow between those rooms when they need to be entered. An airlock may be designed for and used by either people or materials; in the latter case it can be termed a “pass through hatch”. An airlock can also be the “anteroom” to a clean room in which sterile goods are handled.

A

Airlock

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4
Q

A supplier of all components of finished products generally approved for use by the trade and accredited by the manufacturer based on a vendor rating which include but not limited to conformance to the company or compendium material specifications.

A

Approved Supplier

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5
Q

A quantity of drug product/device that is homogenous in character and quality produced during a given cycle of manufacture and from a specific manufacturing order.

A

Batch

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6
Q

A designation in numbers or letters or combination thereof that identifies the batch, and permits the tracing of the complete history of a batch, including all stages of its production, control and distribution.

A

Batch Number/ Lot Number

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7
Q

A contained system, such as a fermenter, into which biological agents are introduced together with other materials in order to effect their multiplication or their production of other substances by reaction with other materials. Generally equipped with devices for regulation, control connection, material addition and material withdrawal.

A

Biogenerator

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8
Q

Microbiological Agents including genetically engineered microorganisms, cell
cultures, as well as endoparasites, whether pathogenic or not.

A

Microbiological Agents

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9
Q

Whole blood collected from a single donor and processed either for transfusion
or further manufacturing.

A

Blood

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10
Q

Any processed material which has to undergo another process including
packaging operation to become a finished product.

A

Bulk Product

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11
Q

The operations carried out to determine the accuracy of measuring instruments, of “material measures” such as masses or gauges and of measurement standards.

A

Calibration

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12
Q

A system whereby successive batches of a product manufactured by culture in cells derived from the same master cell bank (see Master Cell Bank). The cell bank system is validated for a passage level or number of population doubling beyond that which was achieved during routine production.

A

Cell Bank System

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13
Q

The in-vitro growing of cells isolated from multicellular organisms.

A

Cell Culture

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14
Q

An area with defined environmental control of particulate and microbial contamination, constructed and used in such a way as to minimize the introduction, generation and retention of contaminants within the area.

A

Clean Area

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15
Q

The in-vitro serological tests performed on donor and recipient blood samples to establish the serological matching of a donor’s blood or blood components with that of a potential recipient.

A

Compatibility Testing

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16
Q

Any material intended to be used for the manufacture of a product whether raw
or packaging materials.

A

Component

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17
Q

An area constructed, operated and equipped with air-handling and filtration system in order to prevent contamination of the external environment by biological agents from within the area.

A

Contained Area

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18
Q

Anything that cause contamination to the product.

A

Contaminants

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19
Q

An area constructed and operated to control the introduction of potential contamination (an air supply approximately class III may be appropriate), and the consequences of accidental release of living organisms. The level of control exercise shall reflect the nature of the organism employed in the process. The area shall be maintained at a pressure negative to the immediate external environment and allow for the efficient removal of small quantities of airborne contaminants.

A

Controlled Area

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20
Q

Contaminations of a starting, intermediate product or finished product.

A

Cross Contamination

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21
Q

A container designed to store liquefied gas at extremely low temperature.

A

Cryogenic Vessel

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22
Q

A container designed to store gas at a high pressure.

A

Cylinder

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23
Q

The date indicating the start of processing of every batch.

A

Date of Manufacture

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24
Q

The activity of weighing, counting or measuring and checking of starting materials and issuing these to the appropriate production personnel; details of the activity being duly and properly documented.

A

Dispensing

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25
Q

Written recording of all procedures, instructions and processes involved in the
manufacture of drug products.

A

Documentation

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26
Q

Any substance or mixture of substances in finished dosage forms that is manufactured, offered for sale, or presented for use in (1) the treatment, mitigation, cure, prevention, or diagnosis of disease, abnormal physical state, or the symptoms thereof in man or animal; or (2) the restoration, correction or modification of organic functions in man or animal; regardless of whether it is in package form.

A

Drug Product

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27
Q

Instrument, apparatus, or contrivances, including their components, parts and accessories, intended (1) for use in the diagnosis, cure, mitigation, or prevention of disease in man and animals; or (2) to affect the structure or any function of the body of man or animal.

A

Device

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28
Q

A date fixed for each individual batch on or before which the batch is expected
to meet the standard specifications for quality, safety and efficacy.

A

Expiration Date

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29
Q

Any area used for the collection, processing, compatibility

testing, storage or distribution of blood and blood components.

A

Facilities (For Blood Products)

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30
Q

This refers to the building, premises and equipment necessary in the manufacture of drugs.

A

Facilities (For Other Products: drugs, medical devices, bulk chemical material and others)

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31
Q

A product which has undergone all stages of manufacturing operations.

A

Finished Product

32
Q

It is the system of quality assurance aimed at ensuring that products are consistently manufactured to a quality appropriate for their intended use. It is thus concerned with both manufacturing and quality control processes and procedures.

A

Good Manufacturing Practice (GMP)

33
Q

Contaminated with extraneous biological agents and therefore capable of
spreading infection.

A

Infected (man or animal)

34
Q

Checks and tests instituted and carried out in the course of the manufacture of
a drug to assure identity, strength, quality and purity.

A

In-Process Control

35
Q

Any processed substance or mixture of substances which has to undergo one
or more further stages of processing to become finished product.

A

Intermediate Product

36
Q

The process in which blood is extracted from the donor, a LEUKOCYTE CONCENTRATE IS SEPARATED, and the remaining formed elements and residual plasma are returned to the donor.

A

Leukopheresis

37
Q

Gases that, at the specified temperature and pressure, remain as a liquid in the
cylinder.

A

Liquefied Gases

38
Q

A batch or any portion of batch produced by a continuos process, an amount of drugs produced in a unit of time or quantity in a manner that assures its uniformity and in either case which is identified by a distinctive lot number and has uniform character and quality within specified limits.

A

Lot

39
Q

Equipment or apparatus designed to enable one or more gas containers to be
filled simultaneously from the same source.

A

Manifold

40
Q

The complete set of activities to produce a drug that comprise production and quality control from dispensing of materials to the release for distribution of the finished product.

A

Manufacture or Manufacturing

41
Q

A culture of fully characterized cells filled into containers in a single operation, processed together and stored to ensure uniformity and stability. A master cell bank is normally stored at -70oC or lower.

A

Master Cell Bank

42
Q

A culture of a microorganism distributed from a single bulk into containers in a
single operation to ensure uniformity, stability and to prevent contamination.

A

Master Seed Lot

43
Q

The process of packing which is that part of the production cycle applied to a
bulk product to obtain the finished product.

A

Packaging

44
Q

Any material used in the packaging of a bulk product to obtain the finished
product.

A

Packaging Material

45
Q

The liquid portion of blood separated and used as material to prepare another product.

A

Plasma (for further manufacture)

46
Q

The process in which blood is extracted from the donor, the PLASMA IS SEPARATED from the formed elements and at least the red blood cells are returned to the donor.

A

Plasmapheresis

47
Q

The process in which blood is extracted from the donor, the PLATELET CONCENTRATE IS SEPARATED and the remaining formed elements and residual plasma are returned to the donor.

A

Plateletpheresis

48
Q

The degree of variation between individual test results when the method is used separately to different samples drawn from the same batch of material. This will include variation between analysts, between days, between tests on the same prepared extract of a given sample, between different extracts and between laboratories conducting the same test. I

A

Precision

49
Q

Presicion is normally divided into two types: ___ and ____

A
  • Repeatability (within laboratory), and

- Reproducibility (between laboratories).

50
Q

A system of containment that prevents the dispersal of a biological agent into the immediate working environment. It involves the employment of closed containers or safety biological cabinets accompanied with secure operating procedures.

A

Primary Contaminant

51
Q

Description of the operations to be executed, the precautions to be implemented
directly or indirectly related to the manufacture of a drug.

A

Procedures

52
Q

The part of production cycle starting from weighing of raw materials to finished
product.

A

Processing

53
Q

Any process employed after collection and before computability testing of blood. It includes the identification of a unit of donor blood, the preparation of components from such unit of donor blood, serological testing, labeling and associated record keeping.

A

Processing of Blood

54
Q

All operations starting from dispensing of materials to processing, packaging, to finished product.

A

Production

55
Q

All control measures taken designed to ensure that finished products consistently conform to established specification of identity, strength, purity and quality.

A

Quality Control

56
Q

An act of holding off a material for use, or a product for packaging or distribution by physically setting it apart or by system duly validated, pending a decision on release or rejection.

A

Quarantine

57
Q

All substances whether active or excipients that are employed in the processing
of a finished product.

A

Raw Material

58
Q

A resolution between the theoretical and actual yield.

A

Reconciliation

59
Q

The incorporation of all or part of previous batches with the required quality into
another batch at a defined step of production.

A

Recovery

60
Q

The status of materials or products which are not permitted to be used for
processing, packaging or distribution.

A

Rejected

61
Q

The status of materials or products which are permitted to be used for
processing, packaging or distribution.

A

Released or Passed

62
Q

A sample representing the lot, the batch, or the total amount of materials based
on a sampling plan.

A

Representative Sample

63
Q

The reworking of all or part of a batch of product of an unacceptable quality from a defined step of production in order that its quality may be rendered acceptable by one or more additional operations.

A

Reprocessing

64
Q

Any finished product which is already in distribution and sent back to the
manufacturer or distributor due to complaint, damage, expiration, validity or
other reasons such as the condition of the container or package which may cast doubt on the product identity, quality, strength and safety.

A

Returned Product

65
Q

All measures taken to assure suitable or adequate environmental conditions in
compliance to GMP.

A

Sanitation

66
Q

Secondary containment is a system of containment that prevents the dispersal of a biological agent into the external environment or into other working areas. It involves the use of rooms with specially designed air handling, the existence of air locks and/or sterilizers for the exit of material. It may add to the effectiveness of primary containment

A

Secondary Contaminant

67
Q

A seed lot system is a system where successive batches of product are derived
from the same master seed lot at a given passage level.

A

Seed Lot System

68
Q

A description of starting material, intermediate, bulk or finished product in terms of its chemical, physical and microbiological characteristics, if any. A specification shall include descriptive and or numerical clauses stating standards and tolerated deviations, whenever applicable.

A

Specification of Material

69
Q

Raw materials used in the production of a finished product (drugs).

A

Starting Materials

70
Q

A room or area of defined environmental condition with controlled particulate and microbial contamination, constructed, equipped and used to eliminate the introduction, generation or retention of contaminants.

A

Sterile Room or Sterile Area

71
Q

Inactivation or reduction to an acceptable level of all viable microorganisms by a
suitable process.

A

Sterilization

72
Q

The quantity that is expected or planned to be obtained at any phase of production of a particular product, based on the quantity of components to be used.

A

Theoretical Yield

73
Q

The volume of blood or one of its components in a suitable volume of
anticoagulant obtained from a single collection of blood.

A

Unit (of Blood)

74
Q

The process of confirming by recognized appropriate means or manner, that any material, process, procedure, activity, system, equipment or mechanics used in production and control consistently achieved the desired results.

A

Validation

75
Q

A culture of cell derived from the master cell bank and intended for use in the preparation of production of cell cultures and normally stored at - 70oC or lower.

A

Working Cell Bank

76
Q

A culture of microorganism derived from the master seed lot and intended for
use in production.

A

Working Seed Lot

77
Q

A condition or set of conditions encompassing upper and lower processing limits and circumstances, within standard operating procedures, which pose the greatest chance of product or process failure when, compared to ideal conditions. Such conditions do not necessarily induce product or process failure.

A

Worst Case

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