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本帖最后由 beiwei5du 于 2017-8-12 07:17 编辑
节选自CDE MANUFACTURING SITE CHANGES 1. Q: Must the inspection which is required for a site transfer have been conducted for the same dosage form? 1. 问题：对于相同剂型的产地变更，是否必须进行检查？ A: Yes. 回答：是的。 2. Q: What is the meaning of "same environmental conditions"? 2.问题：“相同环境条件”指的是什么? A: "Same environmental conditions" refers to such conditions as the same temperature range, the same humidity control range, and the same lighting intensity. 回答：“相同环境条件”指的是相同温度范围、相同湿度控制范围和相同光照强度这些条件。 3. Q: Is moving to/between contract manufacturers covered by SUPAC-IR? 3.问题：SUPAC-IR是否适用于向合同生产商的转移及合同生产商之间的转移? A: Yes. The guidance defines site changes as a change in location of the site of manufacture for both company-owned and contract manufacturing facilities. 回答：是的。指导原则界定的产地变更是指公司所有的以及合同生产厂的产地的变化。 4. Q: If a foreign firm moves to a new manufacturing site (new building) how would they initiate the inspection of that facility? 4.问题：如果国外厂商转移到一个新的产地（新的建筑），他们应如何启动对该厂房设施的检查？ A: The answer is the same whether the new site is foreign or domestic. The submission of a supplement (changes being effected or prior approval) for the site change will trigger an inspection request from the reviewing division. The move to a new manufacturing site may qualify as a level 1 change in which case the proper submission would be an annual report. In either case an applicant could ask the Field to evaluate their facility. Any site change under SUPAC-IR calls for the new site to be in compliance with cGMP regulations. Should the firm wish to schedule an inspection prior to submission of the site change information to the application, a foreign firm should contact the Foreign Inspection Team in the Division of Manufacturing and Product Quality, Office of Compliance, CDER. Domestic firms should contact their local district office. 回答：不论产地是国外的还是国内的，答案相同。上报产地变更的补充申请（changes being effected or prior approval ）后，审查部门将提出检查的要求。转移到新的产地可能符合1 级变更的要求，此时按年度报告上报即可。任何一种情况下，申请人可以要求现场检查部门评价他们的厂房设施。SUPAC-IR中的任何产地变更都要求新地点符合cGMP要求。如果厂商希望在上报产地变更的申请之前安排检查，那么国外的厂商应当与CDER法规检查办公室的生产与产品质量部门的国外检查组联系。国内的厂商应当与当地办公室联系。 5. Q: Some investigators have stated that any 483 observations (no matter how minor) means that the inspection is "violative" for the company. Should a firm assume that if they receive a 483 observation that they are "violative"? 5. 问题：一些研究者指出任何483发现（不论多小），都意味着检查发现公司“违规”。公司是否应假设如果他们收到483 发现，就说明他们属于“违规”？ A: The districts use three classifications, NAI (no action indicated), VAI (voluntary action indicated), and OAI (official action indicated). Generally, a firm classified NAI has no findings or a few insignificant findings and is considered to be in compliance and therefore not violative. A firm classified VAI usually has several violations that can be significant if they are not corrected as soon as possible. If the corrections and commitments appear adequate the firm is not considered to be violative. Generally, when a firm is classified OAI the findings are significant and should result in some or all of the following: withhold approval of an application, a warning letter, or an injunction, seizure, and/or prosecution. A firm will remain OAI until they have corrected the deficiencies. 一般而言，属于NAI 的公司，为无缺陷或有一些不重要的缺陷，认为其符合规定，因此不算违规。属于VAI 的公司，通常有几个违规情况，如果不及时纠正，会造成重大影响。如果及时纠正，做出妥善承诺，则不认为公司违规。一般而言，如果公司属于OAI，则缺陷比较严重，会带来下列部分或全部后果：暂停对申请的批准、发出警告信或强制命令、没收和/或起诉。公司将一直处于OAI 状态，直到纠正缺陷。 6. Q: If a site change described in Section IV includes manufacturing, packaging, and testing together, is it covered? 6. 问题： 如果IV部分描述的产地变更同时包括生产、包装和检验，那么SUPAC-IR是否适用于这种情况？ A: Yes. 回答：是的。 7. Q: When packaging (or testing) is the only part of the manufacturing process which is being moved, is this situation covered by SUPAC-IR? 7.问题： 当包装（或检验）仅仅是要转移的生产工艺中的一部分时，SUPAC-IR是否适用于这种情况？ A: Yes. Originally, only packaging (or testing) site changes which were part of a site change for complete manufacturing operation as described in #1 above were covered by SUPAC-IR. However, that position was recently reassessed by FDA. Packaging or testing site changes separate from the rest of the manufacturing operation are acceptable under SUPAC-IR as described in the cover letter. 回答：是的。最初，SUPAC-IR只涵盖前面#1中描述的做为完整生产工艺产地变更一部分的包装（或检验）地点变更。但最近FDA 对这一看法重新进行了评价。如附信中所述，与生产操作的其余部分分开的包装或检验地点的变更是SUPAC-IR允许的。 8. Q: Does the Center require any communication from the Field when a company reports a site change in the annual report? 8.问题： 当公司在年度报告中报告地点变更时，CDER是否需要与现场审查部门 沟通交流？ A: The facility should have had a successful cGMP inspection within the past two years and the Center does not expect to hear from the Field at the time of submission of the annual report. A firm may request an assessment of a proposed site change from the appropriate FDA district office. 回答：该产地应在近2 年内有cGMP检查合格的证明，CDER不期望在递交年度报告时从现场审查部门得到消息。厂商可要求相应的FDA 地区办公室对其拟进行的产地变更进行评估。 9. Q: Does Section IV apply to the addition of facilities not previously listed, or is it limited to sites already listed in the location of operations section? 9.问题：IV部分是否适用于增加以往未列出的地点，或者说是否仅限于生产地址部分已经列出的产地？ A: SUPAC-IR section IV does include site changes to facilities not already listed in the NDA/ANDA/AADA. For CBE supplements, a new manufacturing site should have an acceptable cGMP status, as previously discussed. 回答： SUPAC-IR IV部分不包括NDA/ANDA/AADA 未列出的工厂产地的变更。对于CBE 补充资料，如前面所述，新的产地应符合cGMP要求。 10. Q: Are build-outs (extensions of a building) considered a SUPAC-IR level 1 site change? 10.问题： 扩建（建筑的延伸）是否属于SUPAC-IR 的1 级产地变更? A: At the current time, the Center's position is that build-outs qualify as level 1 site changes. The change should be reported in the annual report as long as the facility has had a satisfactory cGMP inspection within the last two years. 回答：目前CDER认为扩建属于1 级变更。只要该产地在近2 年内通过cGMP检查，可在年度报告中报告这一变更。 11. Q: Is it possible to have a site change covered under SUPAC-IR when the change results in different/revised SOPs? 11.问题： 当变更导致标准操作规程不同/修订时，产地变更是否适用于SUPAC-IR？ A: If SOPs are different, the implication is that the manufacturing process has also changed. Thus, this site change is not covered under SUPAC-IR. A prior approval supplement is required under 21 CFR 314.70 (b) (2) (vi). 回答：如果标准操作规程不同，表明生产工艺也发生了变化。因此，SUPAC-IR不适用于这类产地变更。按照21 CFR 314.70 (b) (2) (vi)，要按Prior approval supplement申报。 12. Q: What is meant by "personnel common to both manufacturing sites" under part IV. Manufacturing? 12.问题：按照IV部分“生产”，“两个产地通用工作人员”是什么意思？ A: This means personnel "already working on the campus who have suitable experience with the manufacturing process." 回答：这是指“已在厂区工作并掌握该生产工艺相应经验的工作人员。” | 
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