ISO 19617:2018 伝統的な漢方薬—天然物の製造プロセスの一般的な要件 | ページ 6

3.1

active ingredient

crude drug(s) or the crude drug preparation(s) of a traditional Chinese medicine(s)

[SOURCE:WHO guidelines on good manufacturing practices (GMP) for herbal medicines, modified]

3.2

constituent of known therapeutic activity

substance or group of substances that is chemically defined and known to contribute to the therapeutic activity of a crude drug or of a preparation

[SOURCE:WHO guidelines on good manufacturing practices (GMP) for herbal medicines, modified]

3.3

marker substance

chemically defined constituent of a crude drug utilized for control purposes

Note 1 to entry: Marker substances contribute or not to the clinical efficacy. When they contribute to the clinical efficacy, however, evidence that they are solely responsible for the clinical efficacy can be available or not.

Note 2 to entry: Marker substances are generally employed when constituents of known therapeutic activity are not known or are not clearly identified, and are used to identify the crude drug or preparation or calculate their quantity in the finished product.

[SOURCE:WHO guidelines on good manufacturing practices (GMP) for herbal medicines, modified]

3.4

medicinal animal

animal (wild or bred) used for medicinal purposes

3.5

medicinal mineral

mineral used for medicinal purposes

3.6

medicinal plant

plant (wild or cultivated) used for medicinal purposes

Note 1 to entry: Medicinal plants include crude drugs which could be derived from lichen, algae, fungi or higher plants, such as leaves, flowers, fruit, fruiting bodies, seeds, stems, wood, bark, roots, rhizomes or other parts, which are entire, fragmented or powdered.

[SOURCE:WHO guidelines on good manufacturing practices (GMP) for herbal medicines, modified]

3.7

bulk product

product that has completed all processing stages up to, but not including, final packaging

[SOURCE:WHO good manufacturing practices for pharmaceutical products: main principles, modified]

3.8

crude drug

medicinal part obtained from plants or animals, cell inclusions and secretions separated from the origins, their extracts, and minerals

Note 1 to entry: Herbal materials include, in addition to medicinal parts, fresh juices, gums, fixed oils, essential oils, resins and dry powders of herbs.

Note 2 to entry: In some countries, these materials are processed by various local procedures, such as steaming, roasting or stir-baking with honey, alcoholic beverages or other materials.

3.9

crude drug preparation

basis for finished traditional medicinal products that may include comminuted or cut crude drugs, or extracts, tinctures and fatty oils of crude drugs

Note 1 to entry: Crude drug preparations are produced by extraction, fractionation, purification, concentration, or other physical or biological processes. They also include preparations made by steeping or heating crude drugs in alcoholic beverages and/or honey, or in other materials.

3.10

extract

preparation of liquid (liquid extracts and tinctures), semi-solid (soft extracts and oleoresins) or solid (dry extracts) consistency, obtained from medicinal plants, animals and minerals

3.11

finished product

finished dosage form that has undergone all stages of manufacture, including packaging in its final container and labelling

Note 1 to entry: Natural products in this document includes finished products made from one or more crude drugs.

[SOURCE:WHO good manufacturing practices for pharmaceutical products: main principles, modified]

3.12

finished traditional Chinese medicinal product

product consisting of crude drug preparations made from one or more crude drugs

Note 1 to entry: If more than one crude drug is used, the term “mixture crude drugs product” can also be used.

Note 2 to entry: Finished traditional Chinese medicinal products and mixture crude drugs products contain excipients in addition to the active ingredients. However, finished traditional Chinese medicinal products or mixture crude drugs products to which chemically defined active substances have been added, including synthetic compounds and/or isolated constituents from crude drugs, are not considered to be crude drug products.

3.13

material of natural origin

medicinal plant, animal or mineral

3.14

pharmaceutical product

material or product intended for human or veterinary use presented in its finished dosage form or as a starting material for use in such a dosage form

Note 1 to entry: It is subject to control by pharmaceutical legislation in the exporting state and/or the importing state.

[SOURCE:WHO good manufacturing practices for pharmaceutical products: main principles, modified]

3.15

starting material

substance of a defined quality used in the production of a pharmaceutical product, but excluding packaging materials

[SOURCE:WHO good manufacturing practices for pharmaceutical products: main principles, modified]

3.16

manufacture

operations of purchase of materials and products, production, quality control, release and storage of pharmaceutical products, and the related controls

[SOURCE:WHO good manufacturing practices for pharmaceutical products: main principles, modified]

3.17

manufacturer

company that carries out operations such as production, packaging, repackaging, labelling and relabelling of pharmaceuticals

[SOURCE:WHO good manufacturing practices for pharmaceutical products: main principles, modified]

3.18

blending

process of combining materials or different batches to produce a homogeneous intermediate or finished product

[SOURCE:WHO guidelines on good manufacturing practices (GMP) for herbal medicines, modified]

3.19

packaging

operations, including filling and labelling, that a bulk product has to undergo in order to become a finished product

Note 1 to entry: Filling of a sterile product under aseptic conditions or a product intended to be terminally sterilized would not normally be regarded as part of packaging.

[SOURCE:WHO good manufacturing practices for pharmaceutical products: main principles, modified]

3.20

production

operations involved in the preparation of a pharmaceutical product, from receipt of materials, through processing, packaging and repackaging, labelling and relabelling, to completion of the finished product

[SOURCE:WHO good manufacturing practices for pharmaceutical products: main principles, modified]

3.21

qualification

action of proving that any premises, systems and items of equipment work correctly and actually lead to the expected results

Note 1 to entry: The meaning of the word “validation” is sometimes extended to incorporate the concept of qualification.

[SOURCE:WHO good manufacturing practices for pharmaceutical products: main principles, modified]

3.22

quality assurance

concept covering all matters that individually or collectively influence the quality of a product

Note 1 to entry: It is the totality of the arrangements made with the object of ensuring that pharmaceutical products are of the quality required for their intended use. Quality assurance therefore incorporates GMP and other factors, including those outside the scope of this guide such as product design and development.

Note 2 to entry: Information on manufacturing control and quality control are provided in Annex A and B, respectively.

[SOURCE:WHO good manufacturing practices for pharmaceutical products: main principles, modified]

3.23

quarantine

physical or other effective means of isolation implemented while a decision is awaited on the release, rejection or reprocessing of starting or packaging materials, intermediates or bulk or finished products

[SOURCE:WHO good manufacturing practices for pharmaceutical products: main principles, modified]

3.24

specification

list of detailed requirements with which the products or materials used or obtained during manufacture have to conform

Note 1 to entry: They serve as a basis for quality evaluation.

[SOURCE:WHO good manufacturing practices for pharmaceutical products: main principles, modified]

3.25

validation

action of proving, in accordance with the principles of GMP, that any procedure, process, equipment, material, activity or system actually leads to the expected results

Note 1 to entry: See also qualification (3.21) .

[SOURCE:WHO good manufacturing practices for pharmaceutical products: main principles, modified]

3.26

packaging material

material, including printed material, employed in the packaging of a pharmaceutical, but excluding any outer packaging used for transportation or shipment

Note 1 to entry: Packaging materials are referred to as primary or secondary according to whether or not they are intended to be in direct contact with the product.

[SOURCE:WHO good manufacturing practices for pharmaceutical products: main principles, modified]

3.27

contamination

undesired introduction of impurities of a chemical or microbiological nature, or of foreign matter, into or on to a starting material or intermediate during production, sampling, packaging or repackaging, storage or transport

[SOURCE:WHO good manufacturing practices for pharmaceutical products: main principles, modified]

3.28

cross-contamination

contamination of a starting material, intermediate product or finished product with another starting material or product during production

[SOURCE:WHO good manufacturing practices for pharmaceutical products: main principles, modified]

3.29

clean area

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

[SOURCE:WHO good manufacturing practices for pharmaceutical products: main principles, modified]

3.30

batch

lot

defined quantity of starting material, packaging material, or product that are processed in a single process or series of processes so that it is expected to be homogeneous

Note 1 to entry: It is sometimes necessary to divide a batch into a number of sub-batches, which are later brought together to form a final homogeneous batch.

Note 2 to entry: In the case of terminal sterilization, the batch size is determined by the capacity of the autoclave. In continuous manufacture, the batch corresponds to a defined fraction of the production, characterized by its intended homogeneity.

Note 3 to entry: The batch size can be defined either as a fixed quantity or as the amount produced in a fixed time interval.

[SOURCE:WHO good manufacturing practices for pharmaceutical products: main principles, modified]

3.31

consignment

delivery

quantity of a pharmaceutical(s), made by one manufacturer and supplied at one time in response to a particular request or order

Note 1 to entry: A consignment comprises one or more packages or containers and includes material belonging to more than one batch.

[SOURCE:WHO good manufacturing practices for pharmaceutical products: main principles, modified]