【正文】 b (crude drugs)?(????(??)??????????????????????????????????????????)Do you prepare and operate the SOP of sampling which can be representative the stocked base herb (crude drugs)? (?????(??)????????????????????????????????)Do you keep and control by relative SOP of the samples such as original crude drugs, cut crude drugs, extract amp。 subdividing material, etc.?(????(??), ????(??), ????????????????????????????)Do you stock the base herb or crude drugs with the original form?(????????????????????)In case of stock with cut form, do you consider and operate the way to confirm the quality of original form?(???????????????????????????????????????)Do you set and control the SOP about quality control of origin or cut crude drugs? If yes, check the below questions involved with your quality control standard? (???????(??)???????????????????????? ??????, ???????????????????.)The experiment of the Pharmacopoeia or Herbal Pharmacopoeia[?????????(????)]The experiment of in house specification by character producing district(???, ??????????????)The experiment of contaminant(???????)Is the setting appropriate for the management unit of base herb (crude drugs)? (????(??) ?????????????)Do you set and control the quantity of base herb (crude drugs) procured homogeneity as 1 lot?(???????????(??) ??? 1????????????????)Do you set and control the SOP of storage management by properties per each base herb?(??????????????????????????????????)`Do you keep the retention sample? (??????????????)Do you control the temperature and humidity thoroughly? (?????????????)Do you control the insect amp。 rat resistance thoroughly?(????????????)Do you reflect into the storage management work by analyzing the result of monitoring the temperature amp。 humidity, insert amp。 rat resistance, etc.? (???, ?????????????????????????????????)Do you control the contaminant of crude drugs thoroughly?(????(??)???????????????)Do you inspect the remained contaminant such as remained agricultural chemical, heavy metals, sulfur dioxide, mold toxin, benzopyrene, etc.?(????, ???, ????, ?????, ????????????????????????)What do you control not to mix the similar foreign substances, impurities, metal, etc.?(?????????, ????????????????????)Do you manufacture as the established manufacturing method per every lot?(?????????????????????)Are the related matters pretreatment of crude drugs appropriate? And do you set the pretreatment each crude drug?(????(??)??????????????? ?, ????(??)????????????????)Is the 1 product batch size of pretreatment appropriate?(??? 1 ???????????)Are the records clear about the pretreatment process of sorting, clean, dry, cut, grinding, etc.? (??, ??, ??, ??, ?????????????????????)Is the management of extractant appropriate? (?????????????)In case of using the extractant of ethanol, butanol etc, do you have the SOP and control it?(???, ??????????????????????????????????????)Do you set and manage the control standard for reserving the quality equivalence among the lot of extract amp。 subdividing material of crude drugs ?(??(??)??????????????????????????????????????????)In case of longterm storage, do you set the SOP of retest? (????????????????????)In case some of process product by consign, do you review and control the appropriacy of relevant process? (?????????????????????????????????????)Is the matter connected with delivery about the halffinished product by consign appropriate? (??????????????????????)Thank you for your assistance!(????????????.)Appendix 1. Requested DataRequest Data (Please should attach the below data.)No.Check Item (??)Check (O, X) Attached Document Number (??????) 1Validation chart (????????)2Process validation report or summary report(??????????)3Cleaning validation report or summary report (??????????)4Analytical method validation report(???????????)5Computerized system validation report or summary report(??????????????)6Support System Validation report or summary reportPW system amp。 HVAC System (??????????????–??, ??)7A process flow diagram (?????)8The certificate of analysis (??? CoA)*If you have your validation summary report(in English or in Korean), attach yours. But you don’t have the validation summary report, use the attached form._______________________________________________________________________________________________________________________________________________