原則（PRINCIPLE）
生產作業應遵循清楚界定的程序，且符 合優良製造規範的原則，以獲得要求之 品質的產品，並應符合相關的製造及上 市許可。
Production operations must follow clearly defined procedures; they must comply with the principles of Good
Manufacturing Practice in order to obtain products of the requisite quality and be in accordance with the relevant
manufacturing and marketing authorisations.
一般規定（GENERAL）
5.1 生產應由能勝任者執行與監督。 5.1 Production should be performed and supervised by competent people.
5.2 原物料與產品的所有處理，例如接收、
待驗、抽樣、儲存、標示、調配、製造、
分/包裝及運銷，應依書面程序或指令執 行，必要時應予記錄。
5.2 All handling of materials and products, such as receipt and quarantine, sampling, storage, labelling, dispensing, processing, packaging and distribution should be done in accordance with written procedures or instructions and, where necessary, recorded.
5.3 所有進廠的原物料應予核對，以確保託 運物與訂單相符。必要時，容器應予清 潔，並以規定的資料標示。
5.3 All incoming materials should be checked to ensure that the consignment
corresponds to the order. Containers should be cleaned where necessary and labelled with the prescribed data.
5.4 容器之破損及對原物料品質可能產生其 不利影響的任何其他問題，應予調查、
記錄並提報給品質管制部門。
5.4 Damage to containers and any other problem which might adversely affect the quality of a material should be
investigated, recorded and reported to the Quality Control Department.
5.5 進廠原物料及最終產品在接收或加工 後，應即為實體或行政管理上的隔離，
直到其經放行供使用或運銷為止。
5.5 Incoming materials and finished products should be physically or administratively quarantined immediately after receipt or processing, until they have been released for use or distribution.
5.6 採購的半製品/中間產品或待分/包裝產 品，在接收時應視同原料處理。
5.6 Intermediate and bulk products purchased as such should be handled on receipt as though they were starting materials.
5.7 所有原物料及產品皆應在藥廠建立的適 當條件下，並以有條理的方式儲存，以 容許批次的區隔及庫存品的輪換。
5.7 All materials and products should be stored under the appropriate conditions established by the manufacturer and in an orderly fashion to permit batch segregation and stock rotation.
5.8 視需要，應核對產率及進行重量/數量調 和，以確保無超出允收範圍的差異。
5.8 Checks on yields, and reconciliation of quantities, should be carried out as necessary to ensure that there are no discrepancies outside acceptable limits.
5.9 不同產品的生產作業，不得在同一作業 室內同時或接續地執行，除非無混雜或 交叉污染的風險。
5.9 Operations on different products should not be carried out simultaneously or consecutively in the same room unless there is no risk of mix-up or
cross-contamination.
5.10 製程的每一階段，皆應防止產品及原物 料受微生物及其他污染。
5.10 At every stage of processing, products and materials should be protected from
microbial and other contamination.
5.11 處理乾燥的原物料及產品時，應採取特 別的防範措施，以防止粉塵的產生及散 佈。特別適用於高活性或高致敏性物質 的處理。
5.11 When working with dry materials and products, special precautions should be taken to prevent the generation and dissemination of dust. This applies particularly to the handling of highly active or sensitising materials.
5.12 操作全程中，所有原物料、半製品容器、
設備的主要項目及合適時使用的操作室 皆應標示，否則，應以操作中產品或原 物料、其含量（如果可行）及批號等標 示予以識別。可行時，該標示亦應提及 生產階段。
5.12 At all times during processing, all
materials, bulk containers, major items of equipment and where appropriate rooms used should be labelled or otherwise identified with an indication of the product or material being processed, its strength (where applicable) and batch number.
Where applicable, this indication should also mention the stage of production.
5.13 用於容器、設備或作業場所的標示卡應 清楚、明確，且使用公司一致的格式。
標籤上除文字外，使用顏色標示其狀態 (例如：待驗、合格、拒用、清潔…等)，
通常是有幫助的。
5.13 Labels applied to containers, equipment or premises should be clear, unambiguous and in the company's agreed format. It is often helpful in addition to the wording on the labels to use colours to indicate status (for example, quarantined, accepted, rejected, clean, ...).
5.14 為確保用於將產品從一個區域輸送到另 外一個區域的管線及其他設備係以正確 的方式連接，應執行檢查。
5.14 Checks should be carried out to ensure that pipelines and other pieces of equipment used for the transportation of products from one area to another are connected in a correct manner.
5.15 應盡可能避免來自指令或作業程序的任 何偏差。發生偏差時，應由權責人員以 書面認可，適當時需有品質管制部門的 參與。
5.15 Any deviation from instructions or procedures should be avoided as far as possible. If a deviation occur, it should be approved in writing by a competent person, with the involvement of the Quality Control Department when appropriate.
5.16 進入生產廠房應限於被授權人員。 5.16 Access to production premises should be restricted to authorised personnel.
5.17 通常，非藥品之生產應避免在預定生產 藥品的區域與設備中為之。
5.17 Normally, the production of non-medicinal products should be avoided in areas and with the equipment destined for the production of medicinal products.
生產中交叉污染的防止
（PREVENTION OF CROSS-CONTAMINATION IN PRODUCTION）
5.18 應防止原料或產品被另一原物料或產品 污染。該意外交叉污染的風險，源於製 程中未管制之原物料及產品所產生的粉 塵、氣體、蒸氣、噴霧或微生物、設備 上的殘留物及因作業人員的服裝等。該 風險的嚴重性隨污染物的種類及被污染 的產品而異，其中最具危害的污染物是 高致敏性物質、含有活體的生物製劑、
某些荷爾蒙類、細胞毒類及其他高活性 的物質。污染尤對以注射、大劑量及/或 長期投用的產品之使用最具風險。
5.18 Contamination of a starting material or of a product by another material or product must be avoided. This risk of accidental cross-contamination arises from the uncontrolled release of dust, gases, vapours, sprays or organisms from materials and products in process, from residues on equipment, and from operators' clothing. The significance of this risk varies with the type of
contaminant and of product being contaminated. Amongst the most hazardous contaminants are highly sensitising materials, biological
preparations containing living organisms, certain hormones, cytotoxics, and other highly active materials. Products in which contamination is likely to be most
significant are those administered by injection, those given in large doses and/or over a long time.
5.19 交叉污染應以適當的技術或有組織的措 施避免之，例如：
5.19 Cross-contamination should be avoided by appropriate technical or organisational measures, for example:
a) 在隔離的區域(對諸如青黴素類、活疫 苗、活細菌製劑及一些其他生物性製劑 的產品所要求)，或採分隔時段切換生 產，其後應緊接著適當的清潔處理；
a) production in segregated areas (required for products such as penicillins, live vaccines, live bacterial preparations and some other biologicals), or by campaign (separation in time) followed by
appropriate cleaning;
b) 備有適當的氣鎖室及空氣抽除設備； b) providing appropriate air-locks and air extraction;
c) 將未經處理或未經充分處理的空氣之再 循環或再進入所引起的污染風險降到最 低；
c) minimising the risk of contamination caused by recirculation or re-entry of untreated or insufficiently treated air;
d) 製造具交叉污染特別風險之產品的區域 內應保持穿著防護裝；
d) keeping protective clothing inside areas where products with special risk of cross-contamination are processed;
e) 設備的無效清潔是交叉污染的普遍來 源，故應使用已知有效的清潔及去污染 程序；
e) using cleaning and decontamination procedures of known effectiveness, as ineffective cleaning of equipment is a common source of cross contamination;
f) 使用密閉的生產系統； f) using "closed systems" of production;
g) 檢驗設備上的殘留物並使用清潔狀態標 籤。
g) testing for residues and use of cleaning status labels on equipment.
5.20 應依規定程序定期檢查防止交叉污染的 措施及其有效性。
5.20 Measures to prevent cross-contamination and their effectiveness should be checked periodically according to set procedures.
確效（Validation ）
5.21 確效試驗應強化優良製造規範，並依所 界定的程序實施。其結果及結論應予記 錄。
5.21 Validation studies should reinforce Good Manufacturing Practice and be conducted in accordance with defined procedures.
Results and conclusions should be recorded.
5.22 當採用任何新的製造配方或製備方法 時，應採取步驟以證明其對例行操作的 適用性。使用規定的原物料及設備時，
該界定的製程應表現其能生產出與所要 求品質一致之產品。
5.22 When any new manufacturing formula or method of preparation is adopted, steps should be taken to demonstrate its suitability for routine processing. The defined process, using the materials and equipment specified, should be shown to yield a product consistently of the required quality.
5.23 對製造過程可能會影響產品品質及/或製 程之再現性的重大修正，包括設備或原 物料的任何變更，應加以確效。
5.23 Significant amendments to the
manufacturing process, including any change in equipment or materials, which may affect product quality and/or the reproducibility of the process should be validated.
5.24 製程及程序應執行定期關鍵性再確效，
以確保其維持達成預定結果的能力。
5.24 Processes and procedures should undergo periodic critical revalidation to ensure that they remain capable of achieving the intended results.
原料（STARTING MATERIALS）
5.25 原料的採購是一項重要的作業，應有對 供應商具特別且充分瞭解的人員參與。
5.25 The purchase of starting materials is an important operation which should involve staff who have a particular and thorough knowledge of the suppliers.
5.26 原料僅可向在相關規格上列名之經認可 的供應商購買；可能時，應直接向生產 者購買。建議藥廠建立原料規格時應與 供應商討論。涉及原料之生產與管制的 所有層面，包括其處理、標示、分/包裝 的要求，以及申訴和拒用的程序等，與 製造廠及供應商討論是有助益的。
5.26 Starting materials should only be
purchased from approved suppliers named in the relevant specification and, where possible, directly from the producer. It is recommended that the specifications established by the manufacturer for the starting materials be discussed with the suppliers. It is of benefit that all aspects of the production and control of the starting material in question, including handling, labelling and packaging requirements, as well as complaints and rejection
procedures are discussed with the manufacturer and the supplier.
5.27 每一次交貨，應檢查/核對容器的包裝、
封條的完整性及送貨單與供應商標示之 一致性。
5.27 For each delivery, the containers should be checked for integrity of package and seal and for correspondence between the delivery note and the supplier's labels.
5.28 原物料之一次交貨是由不同批次所組成 者，每一批次應各自考慮其抽樣、檢驗 與放行。
5.28 If one material delivery is made up of different batches, each batch must be considered as separate for sampling, testing and release.
5.29 儲存區的原料應適當地標示 (請參見第 五章，第十三條)。標籤上應至少記載下 列資料：
5.29 Starting materials in the storage area should be appropriately labelled (see Chapter 5, Item 13). Labels should bear at least the following information:
產品的指定名稱及其內部參考代碼 (可行時)；
the designated name of the product and the internal code reference where applicable;
接收時所給予的批號； a batch number given at receipt;
合適時，內容物的狀態(例如：待驗 中、檢驗中、放行、拒用)；
where appropriate, the status of the contents (e.g. in quarantine, on test, released, rejected);
合適時，末效日期或再檢驗的日期。 where appropriate, an expiry date or a date beyond which retesting is
necessary.
採用完全電腦化之儲存系統者，上述所有 資料不必以易讀的方式印在標籤上。
When fully computerised storage systems are used, all the above information should not necessarily be in a legible form on the label.
5.30 應有適當的程序或措施來確保每一個原 料容器之內容物的同一性。已抽樣之原 包裝容器應予識別與標示 (請參見第六 章，第十三條)。
5.30 There should be appropriate procedures or measures to assure the identity of the contents of each container of starting material. Bulk containers from which samples have been drawn should be identified (see Chapter 6, Item 13).
5.31 僅有經品質管制部門放行，且還在架儲 期間內的原料始可使用。
5.31 Only starting materials which have been released by the Quality Control
Department and which are within their shelf-life should be used.
5.32 原料只得由指定的人員依書面程序調 配，以確保將正確的原料準確地稱入或 量入潔淨且適切標示的容器中。
5.32 Starting materials should only be dispensed by designated persons, following a written procedure, to ensure that the correct materials are accurately weighed or measured into clean and properly labelled containers.
5.33 每一經調配之原料及其重量或容量，皆 應個別檢查/核對並予以記錄。
5.33 Each dispensed material and its weight or volume should be independently checked and the check recorded.
5.34 每一批次調配的原料應保存在一起，並
5.34 每一批次調配的原料應保存在一起，並