ISO 15378:2017 医薬品の一次包装材料—適正製造基準（GMP）に関連したISO 9001：2015の適用に関する特定の要件 | ページ 6

3.1.1

組織

目的を達成するための責任、権限、および関係を伴う独自の機能を持つ人または人々のグループ

注記 1:組織の概念には、法人化されているかどうかにかかわらず、個人事業主、会社、法人、企業、企業、当局、パートナーシップ、協会、慈善団体または機関、またはそれらの一部または組み合わせが含まれますが、これらに限定されません。またはプライベート。

注記2：この文書では、組織は 一次包装材料（3.6.4） を製造する会社です。

[出典：ISO 9000:2015, 3.2.1, エントリの注 2 を削除し、新しい注 2 をエントリに追加して修正]

3.1.2

品質単位

品質保証 (QA) と品質管理 (QC) の両方の責任を果たす組織単位

注記 1品質部門は， 組織の規模と構造に応じて，個別の QA 部門と QC 部門，または単一の個人（またはグループ）で構成することができる（3.1.1） 。

3.2.1

assembly

fitting together of primary packaging materials (3.6.4) and/or components

Note 1 to entry: Examples can include pipette assemblies for filling, prepared components of injection systems or positioning of needle shields on prefillable syringes.

3.2.2

change control

documented control of changes with an appropriate risk management (3.11.6)

Note 1 to entry: Changes can include, for example, changes in raw materials, specifications, facilities, equipment, production processes and test methods.

3.2.3

Good Manufacturing Practice

GMP

quality control and quality assurance applied in manufacturing (3.5.5)

Note 1 to entry: For the definitions of quality control (3.2.9) and quality assurance, see ISO 9000:2015, (3.3.6 and 3.3.7).

Note 2 to entry: Requirements for Good Manufacturing Practice in the pharmaceutical industry are specified in a quality assurance standard, see Reference [50].

Note 3 to entry: Good Manufacturing Practice (GMP) for primary packaging materials (3.6.4) requires, in addition to suitable provision of personnel, premises and equipment, a quality management system that includes controls for incoming starting materials (3.5.13) , manufacture, corresponding documentation, factory hygiene, final inspection, records of distribution, processing of complaints and self-inspection.

Note 4 to entry: GMP and current Good Manufacturing Practice (cGMP) are equivalent. GMP guidelines are continually updated to the ever-changing requirements of the state-of-the-art. This has resulted in the term cGMP sometimes being used. The pharmaceutical industry expects that organizations (3.1.1) take account of current GMP within their continual improvement programmes.

3.2.4

installational qualification

IQ

process of obtaining and documenting evidence that equipment has been provided and installed in accordance with its specification

[SOURCE:ISO/TS 11139:2006, 2.22]

3.2.5

operational qualification

OQ

process of obtaining and documenting evidence that installed equipment operates within predetermined limits when used in accordance with its operational procedures

[SOURCE:ISO/TS 11139:2006, 2.27]

3.2.6

origination

artwork

all preparative activities prior to print

Note 1 to entry: These include concept, design, graphics, reprographics, film, plate making, silk screens and digital files and masters.

3.2.7

performance qualification

PQ

verification (3.7.13) that the proposed specification for the facility, equipment or system is suitable for the intended use

[SOURCE:ISO/TS 11139:2006, 2.30]

3.2.8

qualification

process to demonstrate the ability to fulfil specified requirements

Note 1 to entry: The term “qualified” can be used to designate the corresponding status.

Note 2 to entry: Qualification comprises design qualification (DQ), installation qualification (IQ) (3.2.4) , operational qualification (OQ) (3.2.5) and could include performance qualification (PQ) (3.2.7) as well as re-qualification.

Note 3 to entry: Qualification can be applied to facilities, equipment and utilities.

3.2.9

quality control

part of quality management focused on fulfilling quality requirements

Note 1 to entry: Quality control includes checking or testing that specifications are met.

[SOURCE:ISO 9000:2015, 3.3.7, modified by adding Note 1 to entry]

3.3.1

airlock

enclosed space to control air-flow

Note 1 to entry: The space typically has at least two interlocked doors between two or more rooms, used either by people or for goods, to control for different conditions, e.g. cleanliness, air-flow upon entering.

3.3.2

calibration

process of checking or adjusting (by comparison with a reference standard) the accuracy of a measuring instrument

Note 1 to entry: Calibration can also be described as the set of operations which establish, under specified conditions, the relationship between values indicated by a measuring instrument or values represented by a material measure, and the corresponding known values of a reference standard.

3.3.3

cleanroom

room within which the number concentration of airborne particles is controlled and classified, and which is designed, constructed and operated in a manner to control the introduction, generation and retention of particles inside the room

Note 1 to entry: The class of airborne particle concentration is specified.

Note 2 to entry: Levels of other cleanliness attributes such as chemical, viable or nanoscale concentrations in the air, and also surface cleanliness in terms of particle, nanoscale, chemical and viable concentrations might also be specified and controlled.

Note 3 to entry: Other relevant physical parameters might also be controlled as required, e.g. temperature, humidity, pressure, vibration and electrostatic.

[SOURCE:ISO 14644‑1:2015, 3.1.1]

3.3.4

clean zone

defined space within which the number concentration of airborne particles is controlled and classified, and which is constructed and operated in a manner to control the introduction, generation, and retention of contaminants inside the space

Note 1 to entry: This class of airborne particle concentration is specified.

Note 2 to entry: Levels of other cleanliness attributes such as chemical, viable or nanoscale concentrations in the air, and also surface cleanliness in terms of particle, nanoscale, chemical and viable concentrations might also be specified and controlled.

Note 3 to entry: A clean zone(s) can be a defined space within a cleanroom or might be achieved by a separative device. Such a device can be located inside or outside a cleanroom.

Note 4 to entry: Other relevant physical parameters might also be controlled as required, e.g. temperature, humidity, pressure, vibration and electrostatic.

[SOURCE:ISO 14644‑1:2015, 3.1.2]

3.3.5

controlled area

controlled environment

area or environment constructed and operated to control the possible introduction of potential contaminants

3.3.6

working area

defined area where origination (3.2.6) , production (3.5.7) , packaging, test or inspection operations are carried out and where such activity will usually be subject to a line clearance (3.5.4)

Note 1 to entry: These areas are physically defined by the use of barriers, floor marking or similar means of definition, and can contain equipment, e.g. production machinery, test equipment, computers, work benches, proofing equipment.

3.4.1

expiration date

expected suitable use limit

Note 1 to entry: See also definition shelf-life (3.4.2) .

Note 2 to entry: This is typically the period during which a primary packaging material (3.6.4) is expected to remain suitable for use if stored under defined conditions and after which it should not be used.

3.4.2

shelf-life

period during which a primary packaging material (3.6.4) is expected to comply with the requirements (specifications)

Note 1 to entry: See also expiration date (3.4.1)

3.5.1

batch

lot

defined quantity of primary packaging material (3.6.4) manufactured in one process or series of processes intended to have uniform characteristics with consistent, homogeneous quality

Note 1 to entry: To meet production requirements or customer needs, a batch can be divided up into a number of sub-batches that are later combined to form a single, consistent batch.

Note 2 to entry: In the case of continuous production, the batch is a fraction of the production defined either as a fixed quantity or as the amount produced in a fixed time interval.

3.5.2

contamination

introduction of any unwanted material into the primary packaging material (3.6.4)

Note 1 to entry: A finished product (3.6.1) can be contaminated by physical (particulate), chemical or biological (bioburden and endotoxin) action.

Note 2 to entry: Contamination can occur for e.g. during production (3.5.7) , packaging, storage and/or distribution from contaminated air systems, personnel, sampling equipment, materials, premises or containers.

3.5.3

cross-contamination

contamination (3.5.2) of a material or of a product with another material or product

Note 1 to entry: Cross-contamination can also be referred to as mix-up or admixture.

Note 2 to entry: See Reference [50].

3.5.4

line clearance

removal (line purge) of everything associated with the prior production run

Note 1 to entry: Typically, line clearance is done prior to a production run to prevent any error and cross-contamination (3.5.3) . Typically, it is required that a production facility (line) and its associated working area (3.3.6) are completely clear of all materials, waste, products, samples, documents, etc. used in the previous production run before the introduction of materials, product samples, documents, etc. needed for the commencement of the next production run.

3.5.5

manufacturing

all operations including purchasing and receipt of materials to production (3.5.7) , packaging, labelling, quality control (3.2.9) , release, storage, distribution of products and the related controls

3.5.6

process aids

material used to facilitate process realization

Note 1 to entry: The material is not included in the product specification and can be removed at or before the final processing stage.

3.5.7

production

processes resulting in primary packaging material (3.6.4)

Note 1 to entry: The processes form the full production cycle, from receipt of starting materials (3.5.13) through processing and packaging, to completion as a finished product (3.6.1) .

3.5.8

quarantine

status of materials or products isolated pending a decision on their subsequent approval or rejection

Note 1 to entry: Quarantined material is typically isolated by physical or other effective means.

3.5.9

realization

result of applying all processes required to achieve the desired output from design to product delivery

3.5.10

reconditioning

processing or reprocessing primary packaging material (3.6.4) to meet specification requirements

3.5.11

reprocessing

repeating part of a production process

Note 1 to entry: Continuation of part of a process after an in-process control test has shown that the part is incomplete, is considered to be part of the normal process, and is not considered reprocessing.

3.5.12

retained samples

materials or finished products (3.6.1) stored for future reference

Note 1 to entry: These samples are generally taken in a sufficient amount and stored under recommended conditions for reference during a defined period of time.

3.5.13

starting material

raw material, components and substances used to produce primary packaging materials (3.6.4)

3.5.14

surface treatment

process to improve primary packaging material (3.6.4) surface

3.6.1

finished product

primary packaging material (3.6.4) which has completed all stages of production (3.5.7)

3.6.2

intermediate product

primary packaging material (3.6.4) which has completed some but not all production stages

Note 1 to entry: An intermediate product needs further processing before it becomes a finished product (3.6.1) .

3.6.3

medicinal product

substance or combination of substances presented for treating or preventing disease in human beings or animals

Note 1 to entry: Any substance or combination of substances that can be administrated to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings or in animals is likewise considered a medicinal product.

Note 2 to entry: See Reference [50].

Note 3 to entry: Medicinal products (3.6.3) can also be referred to as pharmaceutical or drug products, including clinical trial products.

3.6.4

primary packaging material

material used in pharmaceutical packaging which will contain, seal or be used for dose application of a medicinal product and which will have direct contact with the medicinal product (3.6.3)

3.6.5

secondary packaging materials

non-contact packaging materials

3.7.1

approved

confirmed conformity status

Note 1 to entry: Conformity can be confirmed for any stage of the process [ starting materials (3.5.13) , process aids (3.5.6) , packaging material or finished product (3.6.1) ].

3.7.2

batch document

batch record

documents and records that provide a history of the batch (3.5.1) , including information relating to its production (3.5.7) and control, and which facilitate its traceability

3.7.3

batch number

lot number

unique identifier to identify a batch (3.5.1) or lot (3.5.1)

Note 1 to entry: A batch number can be a combination of numbers, letters and/or symbols which identifies a batch (3.5.1) [(or lot (3.5.1) ] and from which the production (3.5.7) and distribution history can be determined.

3.7.4

date of manufacture

date on which one of the first stages in the process of manufacture of the primary packaging material (3.6.4) , or the packaging, or the final release, occurs, and which can be subject to customer agreement

3.7.5

deviation

departure from an approved (3.7.1) standard operating procedure (SOP) (3.7.10) or established standard

3.7.6

documented procedure

procedure that is established, documented, authorized, implemented and maintained

Note 1 to entry: The documentation can be in any form or type of medium.

Note 2 to entry: See SOP (3.7.10) .

3.7.7

double-check

documented verification (3.7.13) of an activity, result or record by a second person or system

Note 1 to entry: A second in-process control check signature, production (3.5.7) and quality records for a batch (3.5.1) signed by a second person or electronic checks can be part of this verification process. Typically, double-checks are signed by a second person.

3.7.8

out of specification

OOS

test results that do not comply with the specification

3.7.9

rejected

status of starting materials (3.5.13) , process aids (3.5.6) , intermediate products (3.6.2) or finished products (3.6.1) whose test results do not comply with one or more of the requirements of the specification, and which have been deemed, usually by the quality unit(s) (3.1.2) , as not suitable for use

3.7.10

standard operating procedure

SOP

authorized, documented procedure (3.7.6) , or set of procedures, work instructions and test instructions

3.7.11

user requirement specification

URS

approved (3.7.1) document that states the product specifications of the material produced on this equipment as well as functional, operational and/or technical aspects of the equipment or process required to produce the desired product

3.7.12

validation

confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled

Note 1 to entry: The objective evidence needed for a validation is the result of a test or other form of determination such as performing alternative calculations or reviewing documents.

Note 2 to entry: The word “validated” is used to designate the corresponding status.

Note 3 to entry: The use conditions for validation can be real or simulated.

Note 4 to entry: Validation can be applied to processes, products and software.

[SOURCE:ISO 9000:2015, 3.8.13, modified by adding Note 4 to entry]

3.7.13

verification

confirmation, through the provision of objective evidence, that specified requirements have been fulfilled

Note 1 to entry: The objective evidence needed for a verification can be the result of an inspection or of other forms of determination such as performing alternative calculations or reviewing documents.

Note 2 to entry: The activities carried out for verification are sometimes called a qualification process.

Note 3 to entry: The word “verified” is used to designate the corresponding status.

Note 4 to entry: In this document the term verification is used to ensure manufacturing systems are properly installed and operating correctly; alternatively this could be done by IQ (3.2.4) and OQ (3.2.5) .

[SOURCE:ISO 9000:2015, 3.8.12, modified by adding Note 4 to entry]

3.8.1

batch release

decision to release the batch (3.5.1) for sale or supply, following a formal review of the batch document (3.7.2) performed by the quality unit (3.1.2) or a person authorized by the quality unit(s) (3.1.2)

3.8.2

rejection

process whereby starting materials (3.5.13) , process aids (3.5.6) , intermediate products (3.6.2) or finished products (3.6.1) which have been deemed, usually by the quality unit(s) (3.1.2) , as not suitable for use

3.8.3

return

process for sending back primary packaging material (s) (3.6.4) to the organization (3.1.1)

3.8.4

rework

action on a nonconforming product, or service to make it conform to the requirements

Note 1 to entry: Rework can affect or change parts of the nonconforming product or service.

Note 2 to entry: to entry:Sorting can be considered to be rework.

[SOURCE:ISO 9000:2015, 3.12.8, modified by adding Note 2 to entry]

3.9.1

homogeneity

uniformity of characteristics and their values throughout a defined quantity of material

Note 1 to entry: Homogeneity can include uniformity of materials or certain characteristics of materials of special significance.

3.9.2

sterile

free from viable microorganisms

[SOURCE:ISO/TS 11139:2006, 2.43]

3.10.1

automated inspection

conformity evaluation performed by inspection equipment without manual intervention

Note 1 to entry: The inspection equipment can include optoelectronics (cameras), laser systems, ultrasonics and their associated data processing functions or others.

3.10.2

final inspection

tests carried out on the finished product (3.6.1) to determine compliance with the specification

3.10.3

in-process control

actions taken during the production process to test product conformity to its specification

Note 1 to entry: Monitoring processes and adjusting the means of production (3.5.7) can be necessary to meet product requirements.

Note 2 to entry: The control of the environment or equipment can also be regarded as a part of in-process control.

3.10.4

reconciliation

comparison between the amount of finished product (3.6.1) theoretically and actually produced or used, making allowance for normal variation

Note 1 to entry: The comparison considers waste, samples or other losses inherent in the process.

3.11.1

quality critical

parameter affecting primary packaging material (3.6.4) quality

Note 1 to entry: A material, process step or process condition, test requirement or any other relevant parameter can be considered to be quality critical if nonconformity to its requirements could have significant detrimental consequences.

3.11.2

risk analysis

process to comprehend the nature of risk and to determine the level of risk

Note 1 to entry: Risk analysis provides the basis for risk evaluation (3.11.4) and decisions about risk treatment.

Note 2 to entry: Risk analysis includes risk estimation.

[SOURCE:ISO Guide 73:2009, 3.6.1]

3.11.3

risk assessment

overall process of risk identification (3.11.5) , risk analysis (3.11.2) and risk evaluation (3.11.4)

[SOURCE:ISO Guide 73:2009, 3.4.1]

3.11.4

risk evaluation

process of comparing the results of risk analysis (3.11.2) with risk criteria to determine whether the risk and/or its magnitude is acceptable or tolerable

Note 1 to entry: Risk evaluation assists in the decision about risk treatment.

[SOURCE:ISO Guide 73:2009, 3.7.1]

3.11.5

risk identification

process of finding, recognizing and describing risks

Note 1 to entry: Risk identification involves the identification of risk sources, events, their causes and their potential consequences.

Note 2 to entry: Risk identification can involve historical data, theoretical analysis, informed and expert opinions, and stakeholder's needs.

[SOURCE:ISO Guide 73:2009, 3.5.1]

3.11.6

risk management

coordinated activities to direct and control an organization with regard to risk

[SOURCE:ISO Guide 73:2009, 2.1]