Organisation that has the legally delegated or invested authority, capacity or power over wholesaling of medicinal products in the
jurisdiction in which it is located.
Contract Acceptor 受託者
執行委託者委託之 GDP 涵 蓋範圍活動的公司
The company who is contracted to conduct an activity covered by GDP by the contract giver.
Contract Giver 委託者
將 GDP 涵蓋範圍之任何活 動委託給另一個合法機構的 公司。
The company who is contracting out any activity covered by GDP to another legal entity.
Due diligence concepts, involving either an
investigation of a business or persons prior to signing a contract, or an act with a certain standard of care.
Export 輸出
允許貨物離開國家海關領域
或經濟區域。 Allow goods to leave the customs territory of the country or economic area.
Within the EEA:
“Any medicinal product with a false representation of:
a) its identity, including its
packaging and labelling, its name or its composition as regards any of the ingredients including excipients and the strength of those
ingredients;
b) its source, including its manufacturer, its country of
manufacturing, its country of origin or its marketing authorisation holder; or
c) its history, including the records and documents relating to the distribution channels used.”
Source: 2013/C 343/01
歐洲經濟區外：
來源：WHO Technical Report
Outside the EEA:
Any medicinal product “which is deliberately and fraudulently
mislabelled with respect to identity and/or source.
Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct
ingredients or with the wrong ingredients, without active ingredients, with insufficient (inadequate quantities of) active ingredient(s) or with fake
packaging.”
Source: WHO Technical Report Series, No. 957, 2010
Free zones and free warehouses
Free zones and free warehouses are parts of the customs territory of the country or economic area or
premises situated in that territory and separated from the rest of it in accordance with national customs regulations.
Good Distribution Practice (GDP)
GDP is that part of quality
assurance which ensures that the quality of medicinal products is maintained throughout all stages of the supply chain from the site of manufacturer to the pharmacy or person authorised or entitled to supply medicinal products to the public.
Holding 儲存 儲存藥品。 Storing medicinal products.
Import 輸入 允許貨物進入海關領域或經
濟區域。 Allow goods to enter the customs territory of the country or economic area.
A written authorisation from the national regulatory authority to manufacture (& distribute) those medicinal products covered under the licence.
Procuring 採購
從製造商、進口商或其他批 發運銷商取得、獲得、或購 買藥品。
Obtaining, acquiring, purchasing or buying medicinal products from manufacturers, importers or other wholesale distributors.
Public Service Obligations
The authorisation/licence holder shall, in respect of a medicinal product that has actually been placed on the market in its
jurisdiction and within the limits of his or her responsibility, ensure appropriate and continued supplies of that product so that the needs of patients in its jurisdiction in respect of such medicinal product are covered.
Action of proving that any equipment works correctly and actually leads to the expected results.
The word validation is sometimes widened to incorporate the concept of qualification.
Quality Risk Management 品質風險管理
在產品生命週期間針對藥品 品質風險之評估、管制、溝 通及審查的系統化流程。
A systematic process for the
assessment, control, communication and review of risks to the quality of the drug (medicinal) product across the product life cycle.
Quality System 品質系統
執行品質政策及確保符合品 質目標之系統各方面的總 稱。(ICH，Q9)。
The sum of all aspects of a system that implements quality policy and ensures that quality objectives are met. (International Conference on Harmonisation of Technical
Requirements for Registration of Pharmaceuticals for Human Use, Q9)
All activities of providing, selling, donating medicinal products to wholesalers, pharmacists, or persons authorised or entitled to supply medicinal products to the public.
Suspected falsified (counterfeit) medicinal product
Any medicinal product suspected to have a false representation of:
a) its identity, including its packaging and labelling, its name or its composition as regards any of the ingredients including excipients and the strength of those ingredients;
b) its source, including its manufacturer, its country of manufacturing, its country of origin or its marketing
authorisation holder; or
c) its history, including the records and documents relating to the distribution channels used.
Temperature
Room Temperature: +15 to + 25 °C Ambient: The required storage temperature of non refrigerated medicinal product; usually stated on the product as ‘store below 25 °C’
or ‘store below 30 °C’.
Transport 運送
在兩個地點之間移動藥品，
其存放未超過不當的時間。 Moving medicinal products between two locations without storing them for unjustified periods of time.
Action of proving that any procedure, process, equipment, material, activity or system actually leads to the expected results (see also Qualification).
Wholesale distribution of medicinal products is all activities consisting of procuring, holding, supplying, importing or exporting medicinal products, apart from supplying medicinal products to the public.
Wholesale distributor 批發運銷商
進行批發運銷活動的操作
者。 Operator who conducts wholesale distribution activities.