ISO 23416:2023 適切な流通慣行の原則における、温度に敏感な医薬品パッケージの一般的な仕様と試験方法 | ページ 6

3.1

good distribution practice

GDP

part of quality assurance which ensures that quality of medicinal products is maintained throughout all stages of the supply chain from the site of manufacturer to the pharmacy or person authorized or entitled to supply medicinal products to the public

[SOURCE:Guidelines of the European Commission, Annex of 2013/C343/01]

3.2

medicinal products

medicine intended for human use or veterinary product administered to any animals, presented in its finished dosage form or as a starting material for use in such a dosage form, that is subject to control by medicinal legislation in both the exporting state and the importing state

[SOURCE:WHO Technical Report Series No.908, Annex 7, modified.]

3.3

temperature-sensitive medicinal product

medicinal product whose quality may be adversely affected by temperature extremes

3.4

temperature-controlled

sequence of transportation events, from the manufacture to the end-user, which maintains temperature-sensitive products within approved temperature specifications

Note 1 to entry: Maintaining temperature control during these transportation events assures that product quality is maintained.

3.5

temperature-recording

continuous measurement to record temperature

3.6

data logger

electronic or mechanical data recorder provided with sensor(s) for measuring the temperature

3.7

coolant

heat-absorbing medium or process

[SOURCE:ISO 15779:2011, 3.11]

3.8

phase changing material

PCM

material with a high heat of fusion that allows it to store or release thermal energy as a form of melting and solidifying at a certain temperature

[SOURCE:ISO 22982-2:2021, 3.2, modified]

3.9

insulated container

thermal container having no devices for cooling and/or heating, either permanently installed or attached

[SOURCE:ISO 830:1999, 4.2.2.1.1, modified — NOTE has been removed.]

3.10

controlled temperature chamber

room or equipment where the temperature uniformity is maintained within a qualified range to ensure product is preserved

3.11

validation

confirmation process, 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.

[SOURCE:ISO 11139:2018, 3.313]