【正文】 bed in a procedure清潔程序316How are rejected materials held under a quarantine system?如何保管不合格品？3178Production and In Process Controls生產(chǎn)和中間控制318Production Operations生產(chǎn)操作319Are weighing and measuring devices of suitable accuracy for their intended use?稱(chēng)重和計(jì)量?jī)x器的準(zhǔn)確度是否和其應(yīng)用場(chǎng)合相適應(yīng)？320　Are the devices periodically calibrated with certified references?這些計(jì)量?jī)x器是否定期用法定標(biāo)準(zhǔn)物校驗(yàn)？321Do containers with subdivided material contain the following information:裝有多次分發(fā)物料的容器是否提供下列信息：322　name of material物料名稱(chēng)323　code or control number物料編碼或控制碼324　weight, if applicable重量（如適用）325　retest date, if applicable復(fù)驗(yàn)期（如適用）326How are critical weighing, measuring or subdividing operation witnessed?關(guān)鍵稱(chēng)重，計(jì)量或分料操作是如何見(jiàn)證的？327　Is an equivalent control used? If so what?是否使用其它等效的控制方法？什么方法？328Are all other critical operations witnessed or subjected to equivalent control?其它所有的關(guān)鍵操作是如何見(jiàn)證的或采用什么等效的控制方法？329Are actual yields pared with expected yields at designated steps in production?實(shí)際收率是否和各個(gè)生產(chǎn)步驟的預(yù)期收率進(jìn)行比較？330How is the processing status of major units of equipment indicated?如何顯示主要設(shè)備單元工藝狀態(tài)？331Time Limits時(shí)間限度332　Are all specified time limits of the operating instructions met?是否符合所有的操作指示規(guī)定的時(shí)限？333How are storage conditions for IM held for further processing determined?用于下一步工藝的IM的儲(chǔ)存條件如何確定的？334Inprocess Sampling and Controls工藝取樣和控制335　Are IPC established to monitor the progress and control the performance of the processing steps?是否建立監(jiān)控工藝步驟的IPC？336Are critical IPC approved by the QU?關(guān)鍵的IPC是否由質(zhì)量部門(mén)批準(zhǔn)？337How is the qualification (training) of the production personnel documented, if they perform the IPC?負(fù)責(zé)IPC的生產(chǎn)員工資質(zhì)確認(rèn)（培訓(xùn)）的文件記錄？338Are sampling methods for IPC described in writing?IPC是否由書(shū)面的取樣方法？339Does inprocess sampling not cause the contamination of sample and/or product?工藝過(guò)程取樣是否會(huì)造成樣品和/或產(chǎn)品的污染？340Blending of Batches of IM or APIs作為一個(gè)批號(hào)的IM和API混合341Are OOS batches blended with other batches meeting the specifications?是否將OOS的批號(hào)與其它合格批號(hào)進(jìn)行混合？342　Are all batches individually tested prior to blending? And do they all meet specification?在混批前，是否對(duì)個(gè)批號(hào)分別化驗(yàn)？是否全部合格？343Is the blending process adequately documented and the blended batch tested for conformance to specifications?混合過(guò)程有無(wú)適當(dāng)?shù)挠涗浺约盎旌虾蟮呐问欠襁M(jìn)行化驗(yàn)？344Does the batch record of the blended batch allow traceability back to the individual batches?混批的批記錄是否可追溯原來(lái)的各個(gè)批號(hào)？345Are blending operations validated if physical attributes of the API resulting from this step are known to be critical?如果API的物理指標(biāo)很關(guān)鍵，是否對(duì)混合操作進(jìn)行了驗(yàn)證？346How is it demonstrated that the blended batch does not affect stability?如何證明混批的穩(wěn)定性？347Is the expiry/retest date based on the oldest batch in the blend?混批的有效期/復(fù)驗(yàn)期是否根據(jù)最老的批號(hào)確定？348Contamination Control污染控制349How is it ensured that carryovers (. degradants) into successive batches of the same IM/API do not affect the impurity profile of the API?如何確定傳遞到同品種IM/API下一批號(hào)，但沒(méi)有影響其API雜質(zhì)分布譜?350What measures are taken in production to prevent contamination of IM/API?生產(chǎn)中采取哪些方法防止污染IM/API？351What specific precautions are taken to avoid contamination of the API after purification?API精制后采取那些特殊措施避免污染？3529Packaging and Identification Labelling of APIs and IM包裝及IM和API標(biāo)簽鑒別353General通則354Are written procedures available describing包材和標(biāo)簽下列操作的書(shū)面程序：355　receipt收貨356　identification識(shí)別357　quarantine待驗(yàn)358　sampling取樣359　examination/testing檢查/化驗(yàn)360　release放行361　of packaging materials and labels ??362Are specifications for all packaging materials and labels established?是否建立所有包材和標(biāo)簽的質(zhì)量標(biāo)準(zhǔn)？363　Are suppliers of primary packaging materials in contact with the product qualified?與產(chǎn)品直接接觸的內(nèi)包材供應(yīng)商是否經(jīng)過(guò)確認(rèn)？364Are records of each delivery of packaging materials and labels kept?是否保存包材和標(biāo)簽的各次分發(fā)記錄？365Packaging Materials包裝材料366Can containers/packaging material used provide adequate protection against deterioration or contamination during transportation?所用的容器/包材在運(yùn)輸過(guò)程中是否受到足夠的保護(hù)，以防止變形或污染？367Are containers cleaned so that they are suitable for their intended use?容器清潔方法是否與其用途相適應(yīng)？368Are written procedures for cleaning in place for reused containers?再次使用的容器是否制定書(shū)面的清洗方法？369　Are all previous labels removed or defaced?原來(lái)的標(biāo)簽是否被移除或涂掉？370Label Issuance and Control標(biāo)簽發(fā)放和控制371Is access to label storage area limited to authorized personnel?是否只有授權(quán)的人員才能進(jìn)入標(biāo)簽存放區(qū)？372Are procedures in place to reconcile the quantities of labels issued and used?是否制定標(biāo)簽發(fā)放和使用數(shù)量的復(fù)核程序？373　Are discrepancies investigated and approved by the QU?發(fā)現(xiàn)數(shù)量差異是否由質(zhì)量部門(mén)調(diào)查批準(zhǔn)？374Are labels bearing batch numbers not used being destroyed? How is it documented?不再使用的已經(jīng)加印批號(hào)的標(biāo)簽是否銷(xiāo)毀？如何記錄？375Are all outdated and obsolete labels destroyed?是否所有的過(guò)期的過(guò)時(shí)的標(biāo)簽均已銷(xiāo)毀？376Are printing devices checked that the imprint conforms to the print specified in batch record?是否核查打印設(shè)備打印設(shè)置符合批記錄要求?377　Is an examination done to check if the correct label is on the packed IM/API? ()對(duì)IM/API包裝上的標(biāo)簽是否正確進(jìn)行核查（）？378Is a representative label included in the batch record?批記錄是否附有標(biāo)簽樣品？379Packaging and Labelling Operations包裝盒貼簽操作380Are written procedures in place ensuring that correct packaging materials and labels are used?是否有書(shū)面程序來(lái)保證所用的物料和標(biāo)簽正確無(wú)誤？381Is physical or spatial separation of labels done when multiple labeling operations are done at the same time?如果進(jìn)行多種標(biāo)簽同時(shí)進(jìn)行貼簽，是否有隔離措施或空間分離？382Labels should indicate the following information (at least):標(biāo)簽應(yīng)有下列信息：383　name of product產(chǎn)品名稱(chēng)384　identifying code and batch number產(chǎn)品編碼和批號(hào)385　storage conditions, when such information is critical to assure quality當(dāng)儲(chǔ)存條件關(guān)系到產(chǎn)品質(zhì)量是，應(yīng)標(biāo)示其條件386If the IM/API is transferred outside of the control of the manufacturer the label as well as requirements of conta