【正文】 investigation. It is required to describe the deviation occurance clearly and make reords. The evaluation focusing on the potential influence from the deviations should be done and the corrective actions must be approved. The deviation investigation should follow the SOP the handling of deviation (Doc. No.:XXX). /Change Control 當(dāng)方案在執(zhí)行的過(guò)程中，出現(xiàn)既定的內(nèi)容或要求與實(shí)際執(zhí)行情況或清潔 驗(yàn)證 的目的不一致，需要對(duì)原批準(zhǔn)方案進(jìn)行改變，執(zhí)行部門應(yīng)按照《改變控制》文件編號(hào)SOPXXX的操作規(guī)程執(zhí)行。 Before implementing the cleaning validation protocol, all instruments and equipments related to cleaning validation should be calibrated or verified. Instruments and gauges should be calibrated and within the calibration due date, instruments and equipments should have been established corresponding operation and maintenance procedure, and sample for cleaning validation have been established testing procedure. Attachment 1 is list of verification for equipments used in the manufacturing and instruments, equipments and gauges used in QC Lab. 驗(yàn)證 所需的試驗(yàn)條件 /Testing condition needed for cleaning validation 、培養(yǎng)基。 Etc. SOP名稱及編號(hào) /SOPs name and number regarding to cleaning 清潔 SOP名稱 SOPs name regarding to cleaning SOP編號(hào) SOPs No. 題目： XXXX片（ 10mg規(guī)格）清潔驗(yàn)證方案 編號(hào)： 頁(yè)碼： 10/50 Cleaning Validation Protocol of XXXX Tablets(10mg) No.: Page:10/50 、用品及設(shè)備 /Media, articles and equipments for cleaning ：飲用水、純化水、壓縮空氣、 75％乙醇。 Production staff should strictly follow the operating SOP for individual process and clean equipments and utensils used in the manufacturing after 10mg strength XXXX Tablets are finished, then inform QC analyst to sample. The object of clean is to make sure chemical residual and microbial residual meet predetermined criteria. /Surface area of individual equipments 設(shè)備名稱 Equipment Name 表面積 （ m2） Surface area 題目： XXXX片（ 10mg規(guī)格）清潔驗(yàn)證方案 編號(hào)： 頁(yè)碼： 11/50 Cleaning Validation Protocol of XXXX Tablets(10mg) No.: Page:11/50 合計(jì) Total 注：計(jì)算允許殘留限度時(shí)，總面積按照 2904dm2計(jì)算。g/dm2 題目： XXXX片（ 10mg規(guī)格）清潔驗(yàn)證方案 編號(hào)： 頁(yè)碼： 13/50 Cleaning Validation Protocol of XXXX Tablets(10mg) No.: Page:13/50 微生物殘留不得超過(guò) 20cfu/25cm2。目檢合格方可取 樣。擦拭完畢，將棉簽頭置具塞試管中。 Add appropriate amount of methanol into a beaker, presoak a swab used for sampling with methanol. Expel the excess methanol from swab by pressing it against the beaker wall. Put the top of swab on the surface of sampling location, bend the handle of swab slightly to make a face of the swab 題目： XXXX片（ 10mg規(guī)格）清潔驗(yàn)證方案 編號(hào)： 頁(yè)碼： 14/50 Cleaning Validation Protocol of XXXX Tablets(10mg) No.: Page:14/50 pletely contact the surface of sampling location, then swab this sampling location as the direction shown in schematic diagram this swab over, swab the same sampling location with another face of swab as the direction shown in schematic diagram 2. Then put the top of swab into a scintillation vial with stopper. There will be two swabs used to clean each sampling location, total two swabs will be collected into one scintillation vial. The whole face within the PVC template should be covered during swabbing. After sampling, clean the surface of sampling location with singleservice cleaning cloth soaked with 75% ethanol. 圖一 圖二 Schematic diagram 1 Schematic diagram 1 /Sampling for microbial testing ? 接觸法 /Contact plate 若取樣點(diǎn)位置光滑平整，面積大于 25cm2，使用表面積為 25cm2的接觸碟以接觸法取樣，取樣方法為：在靠近取樣點(diǎn)的位置打開(kāi)接觸碟上蓋，輕壓接觸碟使其與取樣表面完全接觸后，移開(kāi)接觸碟，立即蓋上平皿并作好標(biāo)識(shí)。角，至聽(tīng)到按閥折斷。擦拭過(guò)程應(yīng)覆蓋整個(gè) PVC 模板內(nèi)所有表面。and bend emphatically it, swab this sampling location as the direction shown in schematic diagram this swab over, swab the same sampling location with another face of swab as the direction shown in schematic diagram 2. The whole face within the PVC template should be covered during swabbing. After sampling, put swab in tube, seal and label, then clean the surface of sampling location with singleservice cleaning cloth soaked with 75% ethanol. Chemical analytical method and acceptable criteria A. 標(biāo)準(zhǔn)品溶液的配制： Standard solution: 標(biāo)準(zhǔn)品溶液濃度計(jì)算公 式： Calculation formula of concentration for standard solution B. 供試品的配制： Test solution: : Chromatographic conditions /System suitability test /Calculation ? 按外標(biāo)法計(jì)算設(shè)備表面殘留量。 if testing results are “not detectable” , report it as ND. Microbial analytical method and acceptable criteria A. 培養(yǎng) /Incubation ? 以 cfu/25cm2形式報(bào)告 Report the result in cfu/25cm2 ? 直接以培養(yǎng)結(jié)束后的菌落數(shù)報(bào)告。 Production staff will clean equipments and utensils according to corresponding SOPs for equipments after the manufacturing of 10mg strength of XXXX Tablets is finished. 清潔結(jié)束后， QC 人員按清潔 驗(yàn)證 方案規(guī)定取樣、對(duì)樣品進(jìn)行檢測(cè)，并報(bào)告檢測(cè)結(jié)果。以下的簽字表明受訓(xùn)者承認(rèn)已接受了培訓(xùn)并理解。 Notes: fill “√” if visual inspection meet the criteria, otherwise provide the reason. 題目： XXXX片（ 10mg規(guī)格）清潔驗(yàn)證方案 編號(hào)： 頁(yè)碼： 26/50 Cleaning Validation Protocol of XXXX Tablets(10mg) No.: Page:26/50 附件三： QC化學(xué)檢測(cè)取樣記錄表（ 2） Attachment 3 Sampling record form for QC chemical testing (2) 生產(chǎn)批號(hào) /Batch No.： 設(shè)備名稱 Equipment Name 取樣點(diǎn) Sample Locations 樣品編號(hào) Sample No. 目測(cè)結(jié)果 Results of Visual inspection 取樣人 /日期 Sampled by /date 內(nèi)表面 T007 配液桶內(nèi)表面 T008 配液桶攪拌槳表面 T009 物料槽內(nèi)壁表面 T010 物料槽篩網(wǎng) T011 物料槽及擴(kuò)展室視窗 T012 擴(kuò)展室進(jìn)料口閥門表面 T013 擴(kuò)展室盲蓋表面 T014 過(guò)濾袋支架內(nèi)表面 T015 連接口內(nèi)表面 T016 出料閥門表面 T017 進(jìn)料口內(nèi)表面 T018 轉(zhuǎn)子表面 T020 篩網(wǎng)表面 T021 進(jìn)料口蓋內(nèi)表面 T022 進(jìn)料口內(nèi)表面 T023 內(nèi)部任意一角表面 T024 呼吸口內(nèi)表面 T025 出料口閥門表面 T026 與壓片機(jī)料斗連接桶內(nèi)表面 T027 料斗內(nèi)表面 T029 料斗閥門表面 T030 填料器內(nèi)部攪拌齒輪表面 T031 題目： XXXX片（ 10mg規(guī)格）清潔驗(yàn)證方案 編號(hào)： 頁(yè)碼： 27/50 Cleaning Validation Protocol of XXXX Tablets(10mg) No.: Page:27/50 設(shè)備名稱