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缺陷包括

 

A. 嚴(yán)重缺陷 Critical 2項(xiàng)：

 

1 Falsification of source of API (Thiamphenicol): Repackaging, relabeling and selling of purchased API from a non-GMP company (Zhejiang Runkang Pharmaceutical Co.Ltd.) as if manufactured in-house

1.原料藥甲砜霉素（Thiamphenicol）貨源造假，對(duì)來(lái)自非GMP工廠的API重新包裝、貼簽后作為本廠生產(chǎn)的API銷售；

 

2. Praziquantel manufactured according to CP process/grade was released as USP process/grade without a full traceability of the testing activities

2.按照中國(guó)藥典工藝/規(guī)格生產(chǎn)的吡喹酮（Praziquantel）作為美國(guó)藥典工藝/規(guī)格放行，檢驗(yàn)活動(dòng)無(wú)法完整追溯。

 

B. 主要缺陷 Major 4項(xiàng)

 

1. The maintenance and the cleaning operations of the manufacturing line used for the production of Praziquantel (API) were found deficient; 

1. 吡喹酮（Praziquantel）生產(chǎn)線的維護(hù)和清潔操作存在缺陷

 

2. The pipes design of some equipment used for the manufacturing of Praziquantel, the handling of change related to these equipment and the instruction used for the transfer of the intermediate solution using nitrogen were found deficient ; 

2. 吡喹酮（Praziquantel）生產(chǎn)用的某些設(shè)備的管路設(shè)計(jì)，與這些設(shè)備有關(guān)的更換處理，以及使用氮?dú)庵脫Q中間體溶液的操作指導(dǎo)均存在缺陷

 

3. The hoses used for unloading of solvent were not identified, had no cleaning status and were stored on a dirty floor of an area not mentioned in the general layout of the site

3.卸溶劑用軟管沒(méi)有標(biāo)識(shí)，無(wú)清潔狀態(tài)，存放在一個(gè)工廠布局圖中未體現(xiàn)出來(lái)的臟地板上

 

4. There was no procedure in place for audit trail and there was no effective audit trail in place to determine any change or deletion of the chromatographic raw data. The audit trial function including the administrator profiles was enabled for all the QC staff

4. 無(wú)審計(jì)追蹤規(guī)程，沒(méi)有有效的審計(jì)追蹤來(lái)確定色譜原始數(shù)據(jù)的修改或刪除；審計(jì)追蹤功能，包括管理員權(quán)限，對(duì)全部QC人員開(kāi)放。