第五章 作業場所及設備 (CHAPTER 5 – PREMISES AND EQUIPMENT)
5.1 作業場所及設備應適當且足夠，以確
保原料藥適當的儲存及防止污染(如 麻醉藥、高致敏性物質、高藥理活性 或毒性的物質)及原料藥的運銷。
Premises and equipment should be suitable and adequate to ensure proper storage, protection from contamination, e.g. narcotics, highly sensitising materials, materials of high pharmacological activity or toxicity, and distribution of active substances.
5.2 應有適當的保全以防止未經授權的
人員進入。
They should be suitably secure to prevent unauthorised access.
5.3 確保原料藥品質特性之必要監測設
備應在可追溯的標準下依照核定的 時程進行校正。
Monitoring devices that are necessary to guarantee the quality attributes of the active substance should be calibrated according to an approved schedule against certified traceable standards.
第六章 作業 (CHAPTER 6 – OPERATIONS) 訂單 (Orders)
6.1 採購原料藥時，製造廠、輸入商或運
銷商須依國內法規進行登記。
Where active substances are procured from a manufacturer, importer or distributor that manufacturer, importer or distributor should be registered according to national law.
收貨 (Receipt)
6.2 原料藥收貨區域應保護原料藥卸貨
時免於受到天氣之影響。收貨區域應 與儲存區域隔離。交付的原料藥應在 收貨時檢查核對，以確認：
Areas for receiving active substances should protect deliveries from prevailing weather conditions during unloading. The reception area should be separate from the storage area.
Deliveries should be examined at receipt in order to check that:
(i) 容器未受損； (i) containers are not damaged;
(ii) 所有安全封緘皆完整且未有竄 改跡象；
(ii) all security seals are present with no sign of tampering;
(iii) 標示之正確性，包括供應商使用 之名稱與廠內名稱不相同時，其間的 關聯性；
(iii) correct labelling, including correlation between the name used by the supplier and the in-house name, if these are different;
(iv) 可取得的必要資訊，例如分析證 明書等；及
(iv) necessary information, such as a certificate of analysis, is available; and
(v) 接收之原料藥與訂單一致。 (v) the active substance and the consignment correspond to the order.
6.3 封緘破損、包裝損壞或疑似可能遭受 Active substances with broken seals, damaged
9
污染的原料藥應採實體方式或同等 效力之電子系統加以隔離，並調查其 原因。
packaging, or suspected of possible contamination should be quarantined either physically or using an equivalent electronic system and the cause of the issue investigated.
6.4 採取特定儲存方式的原料藥，如麻醉
藥 或 特 定 儲 存 溫 度 或 濕 度 之 產 品 等，應立即辨識並依書面指示和相關 法律規定進行儲存。
Active substances subject to specific storage measures, e.g. narcotics and products requiring a specific storage temperature or humidity, should be immediately identified and stored in
accordance with written instructions and with relevant legislative provisions.
6.5 當運銷商懷疑其採購或輸入之原料
藥可能涉及偽、禁藥時，其應以實體 方式或同等效力之電子系統加以隔 離，並通知主管機關。
Where the distributor suspects that an active substance procured or imported by him is falsified, he should segregate it either physically or using an equivalent electronic system and inform the national competent authority of the country in which he is registered.
6.6 拒用之原料應加以標示、管制及隔
離，以免於其未經授權使用於製造及 進一步的運銷。銷毀活動的紀錄應可 立即取得。
Rejected materials should be identified, controlled and quarantined to prevent their unauthorised use in manufacturing and their further distribution.
Records of destruction activities should be readily available.
Active substances should be stored under the conditions specified by the manufacturer, e.g.
controlled temperature and humidity when necessary, and in such a manner to prevent contamination and/or mix up. The storage conditions should be monitored and records maintained. The records should be reviewed regularly by the person responsible for the quality system.
6.8 當需要特定儲存條件時，儲存區域應
予驗證，並在規定的範圍內作業。
When specific storage conditions are required, the storage area should be qualified and operated within the specified limits.
6.9 儲存設施應保持潔淨並避免雜物、灰
塵及蟲鼠。應採取足夠的預防措施以 防止溢漏或破損、微生物侵入及交叉 汙染。
The storage facilities should be clean and free from litter, dust and pests. Adequate precautions should be taken against spillage or breakage, attack by micro-organisms and
cross-contamination.
10
There should be a system to ensure stock rotation, e.g. ‘first expiry (retest date), first out’, with regular and frequent checks that the system is operating correctly. Electronic warehouse management systems should be validated.
6.11 超過末效日期的原料藥應以實體方
式或同等效力之電子系統從核准之 庫存品隔離且不得再供應。
Active substances beyond their expiry date should be separated, either physically or using an
equivalent electronic system, from approved stock and not be supplied.
6.12 原料藥的儲存或運輸委外時，運銷商
Where storage or transportation of active substances is contracted out, the distributor should ensure that the contract acceptor knows and follows the appropriate storage and transport conditions. There must be a written contract between the contract giver and contract acceptor, which clearly establishes the duties of each party.
The contract acceptor should not subcontract any of the work entrusted to him under the contract without the contract giver’s written authorisation.
交貨給客戶 (Delivers to customers)
6.13 供應原料藥僅能由依國內法規登記
的 原 料 藥 運 銷 商 供 應 給 其 他 運 銷 商、製造廠。
Supplies should be made only by distributors of active substances registered according to national law to other distributors, manufacturers or to dispensing pharmacies.
6.14 原 料 藥 應 依 製 造 廠 規 定 的 條 件 運 輸，並採取不會對品質造成有害影響 的方式。產品、批次及容器識別隨時 維持。所有原裝容器的標籤皆應保持 可讀取的狀態。
Active substances should be transported in accordance with the conditions specified by the manufacturer and in a manner that does not adversely affect their quality. Product, batch and container identity should be maintained at all times. All original container labels should remain readable.
6.15 應備有可易於辨識每批原料藥之運
銷的系統，以使其得以回收。
A system should be in place by which the
distribution of each batch of active substance can be readily identified to permit its recall.
資訊的移轉 (Transfer of information)
6.16 運銷商得知潛在會造成供應中斷的
任何資訊或事件，皆應通知相關客 戶。
Any information or event that the distributor becomes aware of, which have the potential to cause an interruption to supply, should be notified
11
to relevant customers.
6.17 運銷商應將從原料藥製造廠收到的
所有產品品質或法規資訊移轉給客 戶，並將從客戶收到的資訊移轉給原 料藥製造廠。
Distributors should transfer all product quality or regulatory information received from an active substance manufacturer to the customer and from the customer to the active substance manufacturer.
6.18 供應原料藥給客戶的運銷商，應提供
原料藥之原製造廠的名稱與地址，及 其所供應的批號。來自製造廠之原始 分析證明書的副本亦應提供給客戶。
The distributor who supplies the active substance to the customer should provide the name and address of the original active substance
manufacturer and the batch number(s) supplied.
A copy of the original certificate of analysis from the manufacturer should be provided to the
customer.
The distributor should also provide the identity of the original active substance manufacturer to competent authorities upon request. The original manufacturer can respond to the competent authority directly or through its authorised agents.
(In this context ‘authorised’ refers to authorised by the manufacturer.)
6.20 分析證明書的特定規範詳述參照西
藥藥品優良製造規範(第二部:原料 藥) PE 009 第 11.4 節。
The specific guidance for certificates of analysis is detailed in Section 11.4 of PIC/S GMP Guide Part II: Basic Requirements for Active Pharmaceutical Ingredients PE 009.