歐盟GMP無(wú)菌新附錄解讀——影響性評估
歐盟GMP無(wú)菌新附錄解讀——影響性評估
發(fā)布日期：2017-03-15 18:11
附錄1第四章人員章節，與前一版本的主要變化分類(lèi)解讀的摘譯如下：
Chapter 4 contains 16 clauses, compared with 10 from the 2007 version. Only 4 clauses are brand new, with others previously located in different sections of Annex.新的附錄1第四章有16條，2007版只有10條。這16條中有4條是全新的。 以下為本文中的術(shù)語(yǔ)解釋?zhuān)?br>Brand New – clauses which do not have any significant correlation to an existing clause from the 2007 version of Annex 1. Each clause is categorized for potential impact individually.全新的——與附件1的2007版本中的現有條款沒(méi)有任何相關(guān)性的條款。每個(gè)條款分別針對潛在的影響進(jìn)行分類(lèi)。
Negligible Change – clauses that will not, or are unlikely to, require action to ensure compliance. These may be exact or near copies of previous clauses, or they may be reworded clauses where the intent has not changed.輕微的變化——可能不需要采取行動(dòng)來(lái)確保合規的條款?？赡苁呛颓耙话姹緱l款的同樣的條款，或是意思沒(méi)有改變但重新進(jìn)行描述的條款。
Minor Change – clauses which are likely only to affect a small number of manufacturers and require only a relatively small effort to become compliant.微小變化——可能只影響少數生產(chǎn)企業(yè)的條款，只需要相對較小的努力就可以符合規定。
Moderate Change – Still a relatively small number of affected manufacturers, but requiring greater effort for compliance.中等變化——只有相對較少的生產(chǎn)企業(yè)受到影響，需要很多的努力以達到合規。
Significant Change – Even with the significant changes, there will be some manufacturers whose practices already align with the new clauses. These changes will be significant because the number of manufacturers currently non-compliant is notably higher than for other changes, and/or the effort to ddress compliance is likely to be substantial compared with other changes.重大變化——即使有重大變化，也會(huì )有一些生產(chǎn)企業(yè)的做法已經(jīng)與新的條款保持一致。這些變化將是非常重要的，因為目前不合規的生產(chǎn)企業(yè)數量明顯高于其他的變化，并且/或者與其他變化相比，需要達到合規的難度更大。
Brand New Clauses in Chapter 4第四章中全新的條款
| Draft草案序號 | Subject內容 | Potential impact潛在影響 |
| 4.1 | Manufacturers required to have sufficient and appropriate qualified/ experienced personnel 生產(chǎn)企業(yè)需要有足夠和合適的合格/有經(jīng)驗的人員 | None – has long been an inherent requirement of the basic GMP principles (clause 2.1). This clause references sterile manufacturing and testing (arguably unnecessarily)無(wú)影響 - 長(cháng)期以來(lái)一直是基本GMP原則的內在要求（條款2.1）。本條款引用了無(wú)菌生產(chǎn)和測試。 |
| 4.4 | Detailed description of gowning and aseptic practice qualification, and ongoing monitoring. Significantly, requires Grade A operators to be monitored on every exit 更衣和無(wú)菌操作確認的詳細描述，以及持續的監控。需要重視的是，要求A級操作人員每次離開(kāi)均需要進(jìn)行檢測。 | Moderate – like that most organisations both qualify operators and monitor Grade A personnel on every exit. However, neither are uniformly global practices and both require considerable resource to implement and maintain.中等 - 大多數企業(yè)都對操作員工進(jìn)行資格確認，并對每個(gè)出A級的人員進(jìn)行取樣檢測。然而，兩者均不是世界統一的操作，所以需要相當多的資源來(lái)實(shí)施和維持。 |
| 4.5 | Rules for disqualification of cleanroom personnel 取消潔凈室人員權限的規定 | Moderate – likely that most organisations have disqualification rules, but they may not be fully consistent with this clause.中等 - 大多數企業(yè)可能有取消權限的規定，但可能與本條款不完全一致。 |
| 4.6 | Establishment of procedures for non-qualified personnel entering cleanrooms 建立沒(méi)有接受過(guò)相應培訓和授權人員進(jìn)入潔凈室的程序 | Minor – likely that most organisations have such procedures, but some may not.輕微 - 大多數企業(yè)可能都有這樣的程序，少部分可能沒(méi)有。 |
第四章中輕微改變
| Draft草案序號 | 2007 | Subject內容 | Explanation of “Negligible Change” Status“輕微的變化”的解釋 |
| 4.7 | 38 | Operator health conditions and checking 操作人員的健康情況和健康檢查 | Almost exact copy. Some word usage clarified. Requirement for health checks changed from “desirable” to “should be performed”. 基本是完全照搬2007版，一些用詞更明確。健康檢查的要求從“理想”變成“應該執行” |
| 4.8 | 39 | Entry to sterile facilities after high risk activities 進(jìn)行過(guò)高風(fēng)險操作后進(jìn)入無(wú)菌室 | Further defined the scope of high risk activities, but almost the same statement. 更進(jìn)一步明確了高風(fēng)險操作的范圍，描述幾乎相同。 |
| 4.11 | 42 | Cleanroom clothing type, quality and use 潔凈服的類(lèi)型、質(zhì)量和使用 | Exact copy 完全一致 |
| Draft草案序號 | 2007 | Subject內容 | Change改變 | Explanation of “Minor Change” Status“微小變化”的解釋 |
| 4.2 | 36 | Number of personnel in cleanrooms 潔凈室人員數量 | Expanded to reference QRM for determination, document in CCS and validate. Additional emphasis on importance for aseptic processing 擴展引用QRM進(jìn)行確定，在CCS中記錄并驗證。更重視無(wú)菌加工的重要性 | Commonly already done, may prompt QRM and validation for some. 通常已經(jīng)執行，可能有一些需要加強QRM和驗證 |
| 4.9 | 40 | Personal items in clean areas 潔凈區私人物品 | The previous list has been expanded to include “other personal items such as mobile phones” 之前的清單增加了“其他私人物品例如手機” | Lack of clarity over whether mobile phones should be prohibited altogether, or whether controlled use of company phones as communication devices in lower level clean areas (e.g. Grade D) may still be permitted. 對于是否應該全面禁止使用移動(dòng)電話(huà)，或者是否允許將公司電話(huà)作為低級別清潔區域（例如D級）的通信設備進(jìn)行控制，尚不清楚。 |
| 4.16 | 73 | Operator behavior in cleanrooms 操作人員在潔凈室的活動(dòng) | Adds statement regarding the potential to change air currents 增加關(guān)于潛在的對氣流的改變的說(shuō)明 | Enables inspectors to seek airflow visualization studies where there is contention on operator intervention 在對操作員干擾有爭議時(shí)，檢查人員可以借助氣流可視化研究 |
| Draft草案序號 | 2007 | Subject內容 | Change改變 | Explanation of “Moderate Change” Status“中等變化”的解釋 |
| 4.3 | 37 | Training of all personnel involved in correct manufacture of sterile products 需要培訓所有無(wú)菌操作相關(guān)人員 | Adds qualification and assessment as an expectation and expands some definitions of roles 增加期望目標“確認和評估”，擴展了一些角色的具體定義 | Qualification and assessment of cleaning, maintenance and monitoring staff may not be universal. 對于清潔人員，維修人員和監測人員的確認和評估可能不普遍。 The concept of assessment may be open to some interpretation 評估的概念展開(kāi)進(jìn)行解釋 |
| 4.13 | 44 | Outdoor clothing and facility clothing 個(gè)人外衣和潔凈室工作服 | Adds recommendation for dedicated socks prior to entry to Grade C 增加在進(jìn)入C級之前穿專(zhuān)用襪子的建議 | This is not universal practice and may require changes to gowning requirements in many cases 這不是普遍的做法，很多情況下可能需要對更衣要求進(jìn)行改變。 |
| 4.14 | 44 | Grade A/B garments A/B級服裝 | Adds requirement for sterile eyewear and garment change at least every work session 增加需要無(wú)菌眼罩，至少每班進(jìn)行更衣 | Sterile eyewear has not been mandated in the past. Previously only masks and gloves were mandated for such frequent change. 無(wú)菌眼罩過(guò)去未被強制執行，之前只有口罩和手套要求如此頻繁的進(jìn)行更換 While many companies currently conform with the new requirement, there will be some organisations that have to make changes to gowning procedures. 雖然很多公司目前都符合新的要求，但也會(huì )有一些公司不得不改變更衣程序。 |
| 4.15 | 45 | Washing and sterilization of clean room garments 潔凈服的清洗和滅菌 | Almost verbatim version of previous clause, but adds requirement to check integrity after washing, prior to sterilization 幾乎照搬上一版本，但增加了在滅菌前清洗后需要檢查完整性 | As a mandated GMP requirement, this will need to be proceduralised, either by the outsourced laundry, or internally, if the washing is done in-house 作為強制性的GMP要求，這將需要通過(guò)外包洗衣或者在內部進(jìn)行程序化 |
第四章中的重大改變
| Draft草案序號 | 2007 | Subject內容 | Change改變 | Explanation of “Significant Change” Status “重大變化”的解釋 |
| 4.10 | 41 | Handwashing, changing and managing garments 洗手和管理服裝的改變 | Adds requirement for visual inspection of garments for cleanliness and integrity (on top of sterilization check) 在滅菌檢查之后，增加對服裝外觀(guān)清潔和完整性的要求 | Many organisations do cleanliness/integrity checks in a cursory or informal way. Now that it is mandated, will require more detailed procedures and arguably documented confirmation that it has been done 許多公司以粗略或非正式的方式進(jìn)行清潔/完整性檢查?，F在，它是強制性的，將需要更詳細的程序，并需要有證明文件證明已經(jīng)完成 |
| 4.12 | 43 | Gowning requirements for all classified areas 所有控制區域的更衣要求 | Practically no change for C or D. C級和D級基本無(wú)變化。 A/B is changed in that: A/B級的改變如下： a)Sterile eyewear is mandated 強制要求佩戴無(wú)菌眼罩 b)Eyewear and masks shall cover all facial skin 眼罩和口罩必須遮住所有面部皮膚 c)Footwear must be sterilized (disinfection no longer sufficient) 鞋套必須是滅菌的（僅消毒是不夠的） | Most organisations already do (a), but even those who do may not meet (b). Some adjustment to application and/or components may be required. Item (c) is unlikely to be an issue in most countries, but the practice of using disinfected footwear is common in Asia, and will require modification. 大多數公司已經(jīng)做到了（a），但是可能達不到（b）?？赡苄枰獙贸绦蚝?或組件進(jìn)行一些調整。（c）項在大多數國家不太可能成為問(wèn)題，但在亞洲使用消毒鞋的做法很常見(jiàn)，需要修改。 |