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[质量信息化] FDA警告信:加拿大Lernapharm (Loris) Inc.

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发表于 2018-9-19 09:43:17 | 显示全部楼层 |阅读模式

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Warning Letter 320-18-73              September 04, 2018
Mr. Razmik Margoosian
President, Lernapharm (Loris) Inc.
2323 Halpern St., Saint-Laurent, Montreal, Quebec, Canada H4S 1S3
Dear Mr. Razmik Margoosian:
The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Lernapharm(Loris) Inc. at 2323 Halpern St., Saint-Laurent, Montreal, from December 4 to12, 2017.
美国FDA于2017年12月4-12日检查了你们位于加拿大蒙特利尔的Lernapharm (Loris) Inc.生产场所。
This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See 21 CFR, parts 210 and 211.
本警告信总结了制剂生产严重违反CGMP的行为。参见21CFR第210和211部分.
Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21U.S.C. 351(a)(2)(B).
由于你们的制剂生产、加工、包装或保存的方法、场所或控制不符合CGMP要求,你们的制剂根据FDCA的501(a)(2)(B)以及21U.S.C. 351(a)(2)(B)被认为是掺假药品。
We reviewed your December 22, 2017, response in detail and acknowledge receipt of your subsequent correspondence.
我们详细审核了你们2017年12月22的回复,并且此告知已收到后续通信。
During our inspection, our investigator observed specific violations including, but not limited to, the following.
检查期间,我们的调查人员发现的具体问题包括但不仅限于以下:
1.   Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).
你公司未建立并遵守适当的书面程序,设计用以防止理应无菌的药品的微生物污染,包括所有无菌和灭菌工艺的验证(21 CFR 211.113(b))。
You failed to adequately validateyour drug manufacturing process for your (b)(4) drug products that you claim achieves “(b)(4) sterilization.” These products are labeled as sterile and are intended for significant indications, including “(b)(4).”
你们未能充分验证你们声称达到“XX灭菌”的XX药品生产工艺。这些药品标示为无菌,并会用于严重症状,包括XX。
For example, you reprocessed multiple batches of (b)(4) drug products, which purport to be sterile, that did not meet process parameters or quality attributes. In one instance,you reprocessed (b)(4) Lot (b)(4) after five biological indicator(BI) strips were found with microbial growth.
例如,你们返工了多批理应无菌的XX药品,但并不符合工艺参数和质量属性。在另一个案例中,你们在发现5个生物指示剂(BI)条有长菌后返工了XX批号XX。
Your (b)(4) process relies on the exposure of your (b)(4) drug products to (b)(4) of approximately (b)(4) for your (b)(4), and per your process summary report, a minimum of (b)(4) within the product bins placed invarious other locations around the room.  
你们的XX工艺依赖于你们的XX药品暴露于XX约XX,并且根据你们的工艺摘要报告,在产品桶中最少有XX放在房间内其它不同地点。
You failed to test the sterility of finished product batches produced by this process, and instead relied on use ofa biological indicator organism (b)(4).
你们未能检测此工艺生产的制剂批次的无菌性,相反只是依赖于使用生物指示剂有机物XX。
Your response states that you do not perform finished product sterility testing because you maintain written records and validation procedures for your parametric release “sterilization program.”
你们回复声称你们并未对成品进行无菌检测,因为你们保留了你们参数放行“灭菌程序”的书面记录和验证程序。
Your response is inadequate. Your firm lacks an adequate sterilization method. You have not demonstrated an ongoing state of control and your products, which purport to be sterile, are produced using manufacturing methods that are inappropriate to support this claim.
你们的回复是不充分的。你们公司缺乏足够的灭菌方法。你们未能证明持续受控状态,以及你们采用了不能充分支持此声明的和平方法生产你们的无菌产品。
In addition, parametric release is only appropriate for robust sterilization methods (e.g., steam sterilization).The robust sterilization method must also be augmented by a strong sterility assurance program, an extensive ongoing characterization of batch process control, and a vigilant quality system. See FDA’s Compliance Policy Guide (CPG)(b)(4) entitled, (b)(4).
此外,参数放行只有适合于稳健的灭菌方法(例如,蒸汽灭菌)。稳健的灭菌方法还必须通过强有力的保证程序、批工艺控制的深入持续特性鉴定以及高度警戒的质量体系来证明。参见FDA合规政策指南(CPG)XX标题XX。
In response to this letter, describe corrections to your manufacturing operation that will establish a high level of sterility assurance. If you intend to implement a terminal sterilization process, provide a robust sterilization method and rigorous validation protocol that assures the new method achieves a sterility assurance level of 10-6 or more (e.g., provide (b)(4) and (b)(4) data for any (b)(4) sterilization method), and uses an appropriate resistant biological indicator that represents the worst-case resistance of microbes that could be found in your environment and product. Regarding the latter, include (b)(4) determinations for each biological indicator lot to demonstrate its resistance to the specific sterilization method proposed for use by your firm.
在回复此函时,请描述你们建立高水平无菌保证的生产操作纠正措施。如果你们想要实施终端灭菌工艺,请提交一个稳健的灭菌方法和严密的验证方案,确保新方法可达到10-6 或更高的无菌保证水平(例如,提供XX灭菌方法的XX和XX数据),并使用代表会在你们环境和产品中发现的最差情形微生物耐受性的适当的耐受性生物指示剂。关于后者,请包括每个微生物指示剂批次的XX检测以证明其耐受你公司所用的特定灭菌方法。
If you plan to continue use of your current (b)(4) step at the conclusion of processing, describe the facility and process improvements that will ensure that units subjected to that step are first produced by aseptic processing.
如果你们在工艺结论中计划持续使用你们当前的XX步骤,请描述对设施和工艺的改进,确保该步骤的单元首先是由无菌工艺所生产的。
Also include the microbiological testing procedures that you will be using in your process validation studies for in-process and finished product testing. Regarding (b)(4) sterility testing, provide your test method, validation protocol, and validation report.
亦请包括你们将在工艺验证的中控和成品检测中使用的微生物检测程序。关于XX的无菌检测,请提交你们的检测方法、验证方案和验证报告。
In addition, provide sterility testing results for all batches of your purportedly sterile (b)(4) batches that have been released and are within expiry. If such testing reveals substandard quality drug products, provide your corrective actions, including notifying customers and product recalls.
此外,你们请提交你们已放行且仍在效期内的据称无菌的XX批次的所有批次无菌检测结果。如果此检测结果显示药品质量不符合标准,则提交你们的纠正措施,包括通知客户和召回产品。
2.   Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).
你公司未能彻底调查所有已销售或未销售的批次产品或其组份未经解释的不符合其质量标准的情况(21 CFR 211.192)。
You failed to conduct thorough investigations into customer complaints for your (b)(4) drug products which purport to be sterile. You did not evaluate all potential causes for customer complaints or extend the investigation to other potentially affected batches and other products.
你们未能对你们应为无菌的XX产品的客户投诉进行彻底调查。你们未评估客户投诉所有可能的原因,或扩展调查至其它可能受影响的批次或其它产品。
For example, you received complaints AR-17-49 (October 23, 2017) and AR-17-50 (October 25, 2017) due to a significant number of leaking (b)(4) of (b)(4). Your investigation found that the (b)(4) seals leaked due to pinholes in the package caused by debris that had accumulated on the sealing (b)(4) of the packaging machine. However, your investigation did not include your assessment of the following:
例如,你们收到由于大量XX的XX泄漏导致的投诉AR-17-49 (2017年10月23日)和 AR-17-50 (2017年10月25日)。你们的调查发现由于包装机的密封XX上累积的碎片导致包装上的针孔而引发XX密封泄漏。但是,你们的调查并未包括你们对以下的评估:
  • other potential contributors to the pinhole problem, such as packaging material integrity prior to production;
  • 其它可能引起针孔问题的因素,如生产前的包材完整性
  • risks that the leaking packages pose to patients and product quality, including lack of sterility;
  • 泄漏包装对患者和产品质量的风险,包括缺少无菌性
  • effectiveness of your corrective actions and preventive actions (CAPA); and
  • 你们CAPA的有效性,以及
  • full evaluation of scope and magnitude to determine impact of the manufacturing problems on other batches of (b)(4) and additional products you manufacture.
  • 对范围和规模的全面评估,以确定生产问题对XX的其它批次和你们生产的其它产品的影响

In addition, your investigations into non-integrity complaints for various products routinely lacked examination of retain samples.
此外,你们对不同产品不完整投诉的调查都缺少对留样的检查。
Your response acknowledges deficiencies in your investigation systems. However, your risk assessment addressing loss of product sterility due to packaging “deterioration” was inadequate. The assessment indicates that the residual risk rating is “low” for consumer exposure to the defective products. Your risk assessment appears to underestimate the hazards of microbial contamination of products with (b)(4) or similar significant indications. Further, you determined that 18 other batches could have been affected by debris on the sealing (b)(4), but you provided no information regarding your investigations into the additional batches.
你们回复说已知晓你们调查系统的缺陷。但是,你们的风险评估对由于包装“退货”导致产品无菌性缺失的解决是不充分的。评估说对于患者暴露于有缺陷的产品的残留风险为“低”。你们的风险评估貌似低估了药品因XX微生物污染或类似重要情况的危害性。另外,你们认为其它18批可能受到密封XX上碎片的影响,但你们并未提供你们对其它批准的调查信息。
In response to this letter, provide:在回复此函时,请提交
  • Your comprehensive investigations into the additional 18 batches potentially affected by     debris on the sealing (b)(4), including your CAPA and a plan to ensure its effectiveness. If these investigations reveal any substandard quality drug products, provide actions that you will take such as notifying customers and product recalls.
  • 你们对另外可能受到密封XX上碎片影响的18批的全面调查,包括你们的CAPA和确保其有效性的计划。如果这些调查显示有任何药品不符合标准,则请提交你们将采取的措施如通知客户和召回产品。
  • An update on your root-cause evaluations and related CAPA for all complaints you received relating to non-integral containers (e.g, leaking containers, dried contents), with special emphasis on further mitigation of human factors associated with the manufacturing process, in-process checks, and final inspection.
  • 对你们根本原因评估的更新,以及你们所收到的与不完整容器(例如,容器泄漏、干燥成分)有关的所有投诉的相关CAPA,特别要强调进一步降低与生产工艺、中控检查和最终检查有关的人为因素风险。
  • An improved process for risk assessment.
  • 改进的风险评估程序
  • Your updated assessment of patient hazards associated with loss of package integrity.
  • 与包装完整性缺失有关的患者危害性更新评估
  • A comprehensive, independent assessment of your overall system for investigations of deviations, atypical events, complaints, out-of-specification results, and failures. Your CAPA should include but not be limited to improvements in investigation competencies, root-cause analysis, remediation, written procedures, and quality unit oversight. Also, include your process for evaluating CAPA effectiveness.
  • 一份对你们偏差、异常事件、投诉、OOS结果和失败调查的全面体系的全面独立评估。你们的CAPA应包括但不仅限于改进调查资质、根本原因分析、弥补、书面程序以及质量部门监管。还需包括你们评估CAPA有效性的流程。

3.   Your firm failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of such stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)).
你公司未能建立并遵守足够的书面程序,用以评估药品的稳定性特性并使用此稳定性检测结果来确定适当的存贮条件和有效期(21 CFR 211.166(a))。
Your firm lacks stability data to support the (b)(4)-month expiration date for your (b)(4) drug products, including (b)(4). For example, your stability studies did not include testing for sterility or container-closure integrity at least at expiry for your stability batches. You received multiple customer complaints of leaking(b)(4) containers and determined the root cause to be your sealing process.
你公司缺少稳定性数据来支持你们药品的XX月有效期,包括XX。例如,你们的稳定性研究并未包括对无菌性或容器密闭器完整性的检测,至少在你们稳定性批次的有效期时间点的检测。你们收到了多份客户关于XX容器泄漏的投诉,并确定根本原因是你们的密封工艺。
It is essential for products to maintain container-closure integrity throughout the labeled expiration period to assure their microbiological and chemical quality.
产品在其所标示的有效期内保持容器密闭器完整性对于确保其微生物和化学质量是非常必要的。
In your response, you provided a summary of test results at 27 months for your oldest available retains of(b)(4). These test results included attributes such as sterility, package integrity, assay, and pH. You state that combining this data with six months of your already acquired accelerated stability data allows you to extrapolate your real-time stability data to 39 months. Your response is inadequate. You failed to provide data demonstrating your (b)(4) products maintain sterility and the integrity of their container-closure system throughout their entire (b)(4)-month labeled shelf life.
在你们的回复中,你们提交了一份你们对现有XX最早批次留样的27个月检测结果摘要。这些检测结果包括的属性有无菌性、包装完整性、含量和pH值。你们声称此数据结合你们已有的加速稳定性6个月数据,可以外推你们39个月的实时稳定性数据。你们的回复是不充分的。你们未能提交数据证明你们的XX产品在其所标示的货架其内保持无菌性和容器密闭器系统完整性。
In response to this letter, provide:在回复此函时请提交
  • a full summary of stability data results for all batches tested, with each time interval, attributes tested, the testing methods used, and the written stability protocol that was followed. Include testing of all microbiological and chemical attributes, and any updated test data to determine whether the integrity of your container-closure systems (and products are sterile, as applicable) is maintained throughout the entire shelf life.
  • 一份对你们所有所测批次的稳定性数据全面汇总,包括每个时间间隔、所检测项目、所用检测方法以及所执行的书面稳定性方案。包括所有微生物和化学属性的检测,以及更新后的检测数据以证明是否你们的容器密闭器系统的完整性(适当时,产品保持无菌)在其整个货架期内得到维护。
  • a comprehensive assessment and CAPA to ensure the adequacy of your stability program. Your CAPA should include, but should not be limited to a remediated standard operating procedure (SOP) describing your stability program; stability-indicating methods; stability studies to support each drug product in its container-closure system before distribution is permitted; an ongoing program in which representative batches of each product are added each year to the program to determine if the shelf-life claim remains valid; and specific attributes to be tested at each station.
  • 一份全面评估以及CAPA,以确保你们稳定性计划的充分性。你们的CAPA应包括但不仅限于弥补后的稳定性程序SOP、稳定性指示性方法、稳定性研究以支持销售前每个药品的容器密闭器系统、每年会增加每个产品代表性批准的持续稳定性计划以确定货架期声明是否保持有效,以及在每个点所检测的特定属性。

4.   Your firm failed to use appropriate air filtration systems for production areas(21 CFR 211.46(c)).
你公司生产区域未能使用适当的空气过滤系统(21 CFR 211.46(c))。
Your firm manufactures (b)(4) products, which purport to be sterile, in areas of insufficient control and air classification. These conditions are inadequate to protect the drug and its container-closure systems during drug production.
你公司在没有充分控制和空气级别的区域生产应为无菌的XX产品。这些条件不足以在药品生产过程中保护药品及其容器密闭器系统。
Sterile products should be produced in cleanrooms that are designed and controlled to meet appropriate cleanliness standards.
无菌药品应在设计和控制为符合适当洁净标准的洁净间内生产。
In response to this letter providethe following:在回复此函时请提交以下:
  • a protocol to review your (b)(4) filling and sealing zone, and support room environments, to determine whether they meet appropriate air classification standards, and any associated plans for facility upgrades.
  • 一份方案用以审核你们的XX灌装和密封区,以及支持房间的环境,以确定其是否符合适当的空气级别标准和所有相关的设施升级计划。
  • a comprehensive identification of all contamination hazards in your manufacturing operations and an independent risk assessment that includes, among other things, your manufacturing processes, equipment, and facilities to ensure their suitability for sterile production; and
  • 对你们生产操作中的所有污染危害进行全面识别,以及一份独立的风险评估包括你们的生产工艺、设备和设施以确保其适合于无菌生产
  • a detailed CAPA plan that describes all actions to be taken relating to facilities, equipment,  manufacturing methods, controls, people, and raw materials to assure sterility.
  • 一份详细的CAPA计划,其中描述将要采取的与设施、设备、生产方法、控制、人员和物料有关的措施以确保无菌性

5.   Your firm failed to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups (21 CFR 211.42(c)).
你公司未能隔离或界定区域或其它此类防止污染或混淆所必须的控制系统(21 CFR 211.42(c))。
You failed to establish a program to evaluate the microbiological quality of the environment in which you manufacture (b)(4), which purports to be sterile. For example, environmental monitoring is performed very infrequently (i.e., (b)(4)).It does not cover all production (b)(4). It also employs limited passive microbiological testing while lacking personnel monitoring and surface monitoring of your firm’s equipment and facilities. The level of monitoring is insufficient to evaluate whether a manufacturing environment is operating in a state of control. You have minimal information on the identity of microorganisms in your environment.
你们未能制订一份程序用以评估你们生产XX无菌产品的环境的微生物质量。例如,环境监测执行不频繁(即XX)。其未覆盖所有生产XX。其还使用了有限的被动微生物检测,缺少人员监测和设备与设施表面监测。监测水平不足以评估生产环境是否在受控状态下运行。你们对于在你们的环境中微生物鉴别只有非常少的信息。
An adequate environmental monitoring program provides timely and sufficient data to assess ongoing control of the environment and assists in assuring low pre-sterilization bioburden. The program should set appropriate alert and action limits, as well as detect adverse environmental conditions and trigger prompt corrective actions that prevent contamination.
一份充分的环境监测计划可及时提供足够的数据评估环境的持续控制,协助确保灭菌前的低生物负载。该计划应设置适当的警戒和行动限,以及发现不良环境条件并触发快速纠正措施以防止污染。
In response to this letter, provide your environmental monitoring procedures. These procedures should include appropriate:
在回复此函时,请提交你们的环境监测程序。这些程序应包括适当的:
  • frequency, location, and duration of sampling; sample size; and specific sampling equipment and techniques;
  • 取样频次、地点和时长,样品量,以及具体的取样设备和技术
  • action and alert limits for each location, and a description of its function and ISO classification;
  • 每个位置的行动和警戒限,以及其职责和ISO级别描述
  • instructions regarding investigations of out-of-limit (OOL) environmental monitoring results; and
  • 关于OOL环境监测结果的调查指导
  • identification of microorganisms detected in environmental monitoring samples. For example, all microorganisms recovered in the filling room should be routinely identified.
  • 环境监测样品中发现的微生物鉴别。例如所有在灌装间发现的微生物均应进行鉴别。

Also provide environmental monitoring and bioburden monitoring data including:
还应提交环境监测和生物负载监测数据,包括:
  • A list of all lots of sterile povidone-iodine produced by your firm since January 2015 and all bioburden tests performed. Annotate which lots were tested for bioburden and timing     of each sample ((b)(4) sterilization or earlier in the process). Include all microbial count test results and state whether microbial identification was performed. If so, provide the identity of each microbe.
  • 你公司自2015年以来生产的所有无菌聚维酮批次清单,以及所执行的生物负载检测。标出哪个批次检测了生物负载,以及每个样品的时间(XX灭菌或工艺中更早时)。包括所有微生物计数检测结果,声明是否进行了微生物鉴别;如有,提交每个微生物的鉴别。
  • A list of all environmental monitoring tests done for sterile (b)(4) production since January 2015, date of the sample, location sampled, and the identity of all  isolated organisms.
  • 一份自2015年1月以来所做的无菌XX生产的所有环境监测测试清单、取样日期、取样位置以及所有分离出的微生物鉴别
  • Your bioburden monitoring and testing procedures.
  • 你们的微生物负载监测和检测程序
  • A list of any out-of-specification results from bioburden or environmental monitoring testing and all original results and related investigations (if any result was re-tested or invalidated).
  • 一份所有生物负载或环境监测检测OOS结果的清单,以及所有原始结果和相关调查(如有任何复测结果或宣布无效的结果)

Additional guidance on aseptic processing无菌工艺更多指南
See FDA’s guidance document, Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice, to help you meet the CGMP requirements when manufacturing sterile drugs using aseptic processing, athttps://www.fda.gov/downloads/Dr ... nces/UCM070342.pdf.
参见FDA指南文件“无菌工艺生产的无菌药品—CGMP”。
CGMP consultant recommended  CGMP顾问建议
Based upon the nature of the violations we identified at your firm, we strongly recommend engaging a consultant qualified as set forth in 21 CFR 211.34, to assist your firm in meeting CGMP requirements. We also recommend that the qualified consultant perform a comprehensive audit of your entire operation for CGMP compliance and evaluate the completion and effectiveness of corrective actions and preventive actions before you pursue resolution of your firm’s compliance status with FDA.
依据我们在你们工厂发现的违规情况,我们强烈建议你们使用一位有21 CFR211.34所述资质的顾问来协助你们公司符合CGMP要求。我们还建议由具备资质的顾问对你们全面操作进行CGMP合规性综合审计,并在你公司寻求符合FDA法规解决方案之前评估你们已实施的所有CAPA的完整性和有效性。
Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for fully resolving all deficiencies and ensuring ongoing CGMP compliance.
你们使用顾问并不解除你们公司符合CGMP的义务。你们公司的高级管理层仍负有义务全面解决所有缺陷,确保持续CGMP符合性。
Conclusion 结论
Violations cited in this letter are not intended as an all-inclusive list. You are responsible for investigating these violations, for determining the causes, for preventing their recurrence, and for preventing other violations.
此函中所引用的违规并不是全部。你们有责任对这些偏差进行调查,确定原因,防止其再次发生,防止其它偏差的发生。
FDA placed your firm on Import Alert 66-40 on April 24, 2018.
你公司已于2018年4月24日被FDA放入进口禁令66-40项下。
Until you correct all violations completely and we confirm your compliance with CGMP, FDA may withhold approvalof any new applications or supplements listing your firm as a drug manufacturer.
在贵公司未能完成所有偏差纠正并且由我们确认你们符合CGMP之前,FDA可能会搁置所有将你公司列为药品生产的新申报和增补申报的批准。
Failure to correct these violationsmay also result in FDA continuing to refuse admission of articles manufactured at Lernapharm (Loris) Inc. of 2323 Halpern St., Saint-Laurent, Montreal, into the United States under section 801(a)(3) of the FD&C Act, 21U.S.C. 381(a)(3). Under the same authority, articles may be subject to refusal of admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of theFD&C Act, 21 U.S.C. 351(a)(2)(B).
未能纠正这些偏差可能还会导致FDA依据FDCA第801(a)(3)条和21 U.S.C. 381(a)(3)拒绝接受在上述地址生产的产品进入美国。
After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done since our inspection to correct your violations and to prevent their recurrence. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.
在收到此函后,请在15个工作日内回复至本办公室。在回复中说明自从检查后,你们做了哪些工作来纠正你们的偏差,防止其再次发生。如果不能在15个工作日内完成纠正措施,说明延迟的原因以及完成计划。
Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov or mail your reply to:
Philip Kreiter
Compliance Officer
U.S. Food and Drug Administration
White Oak Building 51, Room 4359
10903 New Hampshire Avenue
Silver Spring, MD 20993
USA
Please identify your response with FEI 3004158845.
Sincerely,
/S/
Francis Godwin
Acting Director
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation andResearch

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