7月15日，省局在六安召开2025年上半年药品生产质量安全风险会商交流会。省局党组成员、副局长张磊出席会议并讲话，省局有关处室、直属单位、各分局负责人及药品生产监管人员参加会议。各参会部门单位分别从许可审评、监督检查、抽检、药物警戒、案件查办、投诉举报、舆情监测等方面，回顾分析上半年药品生产质量风险排查整治情况，分享交流特色工作做法，逐家分析企业特征、风险薄弱环节，研判当前风险形势，会商风险化解措施，推进全年药品生产监管工作。会议指出，上半年全省扎实推进药品生产本质安全提升行动，多措并举、标本兼治，持续深化、巩固、创新防控药品安全风险的办法举措，稳步推进药品生产监管各项工作任务，药品生产企业质量管理水平得到有效提升，全省药品生产安全形势持续保持稳定。会议强调，各级监管部门要进一步提高政治站位，不断增强做好药品生产监管工作的紧迫感、责任感和使命感，既要懂专业，也要懂企业、懂行业、懂产业，增强对风险的洞察力和敏感性，做到时时放心不下、事事心中有底、处处用心用力，未雨绸缪，防患未然。会议要求，下半年继续纵深推进药品安全本质安全提升行动，压实药品生产企业主体责任，突出重点对象、重点品种、重点环节，持续增强监管质效，积极主动防控药品安全风险。一要开展预防性监管，以案为鉴，让监管跑在风险前面。二要持续加强集采药品监管，开展集采药品“回头看”检查巡查，紧抓药学变更、成本控制等关键环节，确保价格合理、质量不降、供应得上。三要寓监管于服务之中，多形式开展普法培训和警示教育，不断压实企业主体责任。四要深化整改闭环管理工作，推行整改攻坚行动，跑好监管检查的最后一公里。会议当晚，还组织了集采药品生产监管和缺陷整改闭环管理沙龙活动，解读了融合检查工作机制，对集采药品检查重点和方法进行了讨论，进一步统一思想认识、总结监管经验、完善制度机制，以更实更细的举措扎紧药品质量安全的藩篱。

Delivery Method:VIA Electronic MailReference #:320-25-84Product:DrugsRecipient:Ms. Lori A. PetersonChief Information Officer Quality Assurance/OwnerNature’s Fusions LLC57 North 1380 WestOrem,UT84057United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-25-84June 25, 2025Dear Ms. Peterson:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Nature’s Fusions LLC, FEI 3012853845, at 57 North 1380 West, Orem, Utah, from January 15 to 21, 2025.This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).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), 21 U.S.C. 351(a)(2)(B).We have not received a response from your firm stating the actions you are taking to address the deficiencies identified during the inspection and cited on our Form FDA 483.During our inspection, our investigator observed specific violations including, but not limited to, the following.1. Your firm failed to establish a written testing program designed to assess the stability characteristics of drug products and determine appropriate storage conditions and expiration dates. Your firm also failed to have buildings used in the manufacture, processing, packing, or holding of drug products with adequate space for the orderly placement of equipment and materials to prevent mix-ups and contamination (21 CFR 211.166(a) and 21 CFR 211.42(b)).Your facility repackages and manufactures over-the-counter (OTC) drug products, such as hand sanitizers. You failed to establish an adequate stability program that includes adequate chemical and microbial testing and lacked adequate controls for material storage.Lack of Stability StudiesYou used expired bulk ethanol hand sanitizer gel for repackaging into smaller units and assigned a two-year expiry date without conducting stability studies. In addition, you did not conduct stability studies for isopropyl alcohol (IPA) spray hand sanitizers manufactured onsite to demonstrate that your OTC drug products will remain acceptable throughout their assigned two-year expiry period.Inadequate Material StorageBulk totes of ethanol hand sanitizer gel were stored outdoors, and you informed our investigator that these totes had been stored outdoors since April 2020. Labeling for the bulk ethanol hand sanitizer gel lists a temperature storage range of(b)(4)F. The totes are exposed to temperature excursions that often exceed the specified temperature storage range, which could compromise the quality of the drug product therein.In response to this letter, provide:A comprehensive, independent assessment and corrective action and preventive action (CAPA) plan to ensure the adequacy of your stability program. Your remediated program should include, but not be limited to:o Stability indicating methods.o Stability studies for each drug product in its marketed container-closure system before distribution is permitted.o 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.o Detailed definition of the specific attributes to be tested at each station (timepoint).o All procedures that describe the listed elements of your remediated stability program.A comprehensive, independent assessment of all drug products in the U.S. market to determine if you have data to support that they conform to specifications throughout their shelf-life, including evaluating storage conditions, differences in each formulation, packaging configurations, and all historical stability studies that have been performed. If there are gaps in the data needed to scientifically support that your drug products retain their quality attributes through their labeled shelf-life, provide a CAPA plan which will include an impact assessment for any batches that remain within their shelf-life in the market.A summary of results from testing reserve samples within expiry for all drug product batches not currently in your existing stability program. Testing of each batch should be completed within 60 days of this letter. You should test all appropriate quality attributes including, but not limited to, identity and strength of active ingredients as well as microbiological quality of each batch. If testing yields an out-of-specification result, indicate the corrective actions you will take, including notifying customers and initiating recalls.2. Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)).You failed to test all incoming raw materials, including isopropyl alcohol received from suppliers, used to manufacture your OTC hand sanitizer drug product. You relied on your supplier’s certificate of analysis (COA) for components, such as isopropyl alcohol, in lieu of testing each component for purity, strength, identity, and quality.You manufacture drugs that contain IPA. Methanol substitution in alcohols has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance documentPolicy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanolat https://www.fda.gov/media/173005/download.Without adequate testing and confirmation of reliability of supplier and external laboratory testing results, you lack scientific evidence that the components or drug products conform to appropriate specifications.In response to this letter, provide:A comprehensive, independent review of your material system to determine whether all suppliers of components, containers, and closures, are each qualified and the materials are assigned appropriate expiration or retest dates. The review should also determine whether incoming material controls are adequate to prevent use of unsuitable components, containers, and closures.The chemical and microbiological quality control specifications you use to test and release each incoming lot of component for use in manufacturing.A summary of results obtained from testing all components to evaluate the reliability of the COA from each component manufacturer. Include your standard operating procedures that describes this COA validation program.A summary of your program for qualifying and overseeing contract facilities that test the drug products you manufacture.Methanol testing for all hand sanitizer batches released and distributed in the United States within expiry.3. Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release. Your firm also failed to conduct, for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms (21 CFR 211.165(a) and 211.165(b)).You failed to conduct adequate finished product release testing for each batch of your drug product, including but not limited to, testing the identity and strength of the active ingredient, isopropyl alcohol and testing for objectionable microorganisms. For example, your COA for(b)(4)indicates that you calculated the assay value instead of performing testing, and that you only performed organoleptic evaluation for appearance, color, and odor.Drug product batches must be tested for identity, strength, and purity prior to release. Testing is an essential part of ensuring that the drug products you manufacture conform to all predetermined quality attributes and are appropriate for their intended use. Without adequate finished product release testing, you do not have scientific evidence that each batch of drug product conforms to appropriate specifications before release.In response to this letter, provide:A list of chemical and microbial specifications, including test methods, used to analyze each lot of your drug products before a batch disposition decision.o An action plan and timelines for conducting full chemical and microbiological testing of reserve samples to determine the quality of all batches of drug product distributed to the United States that are within expiry as of the date of this letter.o A summary of all results obtained from testing reserve samples from each batch. If such testing reveals substandard quality drug products, take rapid corrective actions, such as notifying customers and product recalls.4. Your firm failed to establish written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess. (21 CFR 211.100(a)).You used water as a component to manufacture your OTC drug products. You were unable to provide adequate documentation demonstrating that your water system is validated. You failed to routinely monitor your(b)(4)water system for all required quality attributes to ensure that your water, at a minimum, meets the(b)(4)Water USP monograph and appropriate microbial limits. You lacked conductivity and total organic carbon limits and testing and did not test for specific objectionable microorganisms.Your total microbial specification limit is(b)(4). This is above the appropriate limits for water intended for pharmaceutical manufacturing. Our inspection revealed at least one instance of elevated bioburden in 2024(b)(4). These microorganisms were not further isolated to determine the identification of the bacterial species. Furthermore, your current schedule of quarterly microbiological testing is also insufficient.The lack of data regarding the state of control of your water system poses a potential risk for objectionable microbiological contamination into your drug products. Pharmaceutical water must be suitable for its intended use and routinely tested to ensure ongoing conformance with appropriate chemical and microbiological attributes.In response to this letter, provide:A comprehensive, independent remediation plan for the design, control, and maintenance of the water system.o A(b)(4)water system validation report specific for each water system in each building. Also include the summary of any improvements made to system design and to the program for ongoing control and maintenance for each water system.A detailed risk assessment addressing the potential effects of the observed water system failures on the quality of all drug product lots currently in U.S. distribution or within expiry. Specify actions that you will take in response to the risk assessment, such as customer notifications and product recalls.A procedure for your water system monitoring that specifies routine microbial testing of water to ensure its acceptability for use in each batch of drug products produced by your firm.The current action/alert limits for total counts and objectionable organisms used for your(b)(4)water system.A procedure governing your program for ongoing control, maintenance, and monitoring that ensures the system consistently produces water that meets(b)(4)Water, USP monograph specifications and appropriate microbial limits.Drug Production CeasedDuring the inspection, you provided a document indicating that you will discontinue manufacturing of various drug products and did not anticipate renewing your registration as an OTC drug manufacturer. We acknowledge your commitment to cease manufacturing of pain relief rubs and various hand sanitizer drugs. In response to this letter, clarify whether you intend to resume manufacturing any drugs for the U.S. market at this facility in the future.If you plan to resume any manufacturing operations regulated under the FD&C Act, notify this office before resuming your drug manufacturing operations. You are responsible for resolving all deficiencies and systemic flaws to ensure your firm is capable of ongoing CGMP compliance. In your notification to the Agency, provide a summary of your remediations to demonstrate that you have appropriately completed all CAPAs.CGMP Consultant RecommendedIf your firm intends to resume manufacturing drugs for the U.S. market, you should engage a consultant qualified as set forth in 21 CFR 211.34 to assist your firm in meeting CGMP requirements.Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.ConclusionThe violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.Correct any violations promptly. Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction. Unresolved violations may also prevent other Federal agencies from awarding contracts.Failure to address violations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3012853845 and ATTN: Jamie Dion.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research

为进一步指导和规范生物类似药的研究，为不同申报阶段的生物类似药药学相似性研究共性问题提供参考，基于现行评价体系，药审中心组织制定了《生物类似药药学相似性研究的问题与解答》。根据《国家药监局综合司关于印发药品技术指导原则发布程序的通知》（药监综药管〔2020〕9号）要求，经国家药品监督管理局审查同意，现予发布，自发布之日起施行。 特此通告。 附件：生物类似药药学相似性研究的问题与解答国家药监局药审中心2025年7月7日

根据《已上市药品说明书增加儿童用药信息工作程序（试行）》（2023年第68号）及《药审中心关于已上市药品说明书增加儿童用药信息工作细则（试行）》（药审业〔2024〕162号），我中心将已上市药品ω-3鱼油脂肪乳注射液说明书增加儿童用药信息的《品种名单和药品说明书修订建议表》（附件）予以公示，公示期15天。 您的反馈意见请发到以下邮箱：lijj@cde.org.cn 感谢您的参与和大力支持。国家药品监督管理局药品审评中心2025年7月22日

为鼓励、引导药品零售连锁经营，助力企业高质量发展，保证药品质量安全，根据《中华人民共和国药品管理法》《中华人民共和国电子签名法》《药品经营和使用质量监督管理办法》《药品经营质量管理规范》等法律法规规范规定，省药监局起草了《辽宁省药品零售连锁企业使用电子随货同行单管理规定（征求意见稿）》，现向社会公开征求意见。请于2025年8月21日前将相关意见建议反馈至电子邮箱yhltjgc.fda@ln.gov.cn。电子邮件主题请注明“《管理规定》建议反馈”。  特此公告。  辽宁省药品监督管理局   2025年7月22日 辽宁省药品零售连锁企业使用电子随货同行单管理规定（征求意见稿）  第一条为鼓励、引导药品零售连锁经营，助力企业高质量发展，保证药品质量安全，根据《中华人民共和国药品管理法》《中华人民共和国电子签名法》《药品经营和使用质量监督管理办法》《药品经营质量管理规范》等法律法规规范规定，结合我省实际，制定本规定。  第二条本规定的电子随货同行单是指药品零售连锁总部开展药品出库、送货确认，连锁门店开展收货、验收等活动时使用的电子凭证，其效力与纸质随货同行单相同。  第三条我省药品零售连锁企业可使用电子随货同行单从事相关经营活动，同时应遵守法律、法规、规章及本规定的相关要求。  第四条企业应当在统一的计算机管理系统控制和管理下，使用电子随货同行单开展相关经营活动，确保数据原始、真实、准确、安全和可追溯。  第五条连锁门店应配备辅助收货、验收的设施设备，与药品零售连锁总部、门店计算机管理系统实现药品质量基础数据同步共享、互联互通。  相关设施设备应具备按用户名密码权限登录、查询加盖出库专用章的电子随货同行单、显示待收货或验收药品信息、逐笔确认待收货与验收药品、记录异常药品信息、记录操作人员、操作时间等功能。  连锁门店辅助收货验收的设施设备可以为手机小程序，或扫码设备配合计算机管理系统等。  第六条待收货或验收药品信息至少包含药品的通用名称、上市许可持有人（中药饮片标明生产企业、产地）、批准文号、剂型、批号、数量、规格、有效期、销售日期等内容。  第七条连锁门店计算机管理系统应具备查询、下载、保存、打印收货验收后的电子随货同行单的功能。  收货验收后的电子随货同行单应注明供货单位名称、药品通用名称、药品上市许可持有人（中药饮片标明生产企业、产地）、批准文号、产品批号、剂型、规格、有效期、销售数量、销售价格、销售日期、验收结果、电子出库专用章、收货单位、收货地址、门店收货或验收人员等内容。  第八条企业相关记录和数据的存储、备份以及保存时限应当符合法律、法规、规章的规定。  第九条企业应建立使用电子随货同行单进行收货、验收、查询、存储的管理制度和操作规程；建立应急预案，应对停电等突发事件。对相关人员进行岗前培训，同时，按照本规定的要求开展内审和风险评估，切实保证药品经营活动持续符合法定管理要求。  第十条本规定自印发之日起施行。

根据《中药品种保护条例》规定，国家药品监督管理局批准天士力医药集团股份有限公司的痰咳净滴丸、石家庄以岭药业股份有限公司的夏荔芪胶囊、湖南德康制药股份有限公司的紫贝止咳颗粒和江西华太药业有限公司的金丹附延颗粒为首家中药二级保护品种，保护品种编号分别为：ZYB2072025018、ZYB2072025019、ZYB2072025020、ZYB2072025021。保护期限自公告日起七年。

　　近日，国家药监局药审中心余欢副主任带队到重庆开展化学药品上市后变更管理专题调研，市药监局党组成员、副局长王力，药品注册处、市药审中心负责人参加。　　余欢副主任一行实地调研了重庆博腾制药科技股份有限公司、重庆药友制药有限责任公司、重庆华邦制药有限公司，并与我市十余家化学药品研发、生产企业进行座谈，深入了解企业化学药品上市后变更管理情况、变更控制系统的建设情况、药品质量体系（PQS）实施情况，同时重点听取了业界对《化学药品批准后药学变更管理方案技术指导原则（上网征求意见稿）》的意见建议。　　余欢副主任强调，药品上市后变更是药品质量持续提升、生产技术迭代更新的重要环节，关系人民群众用药安全可及。一是要严格坚持“保安全、守底线”的核心定位，构建覆盖变更全流程的科学管理体系，压实企业主体责任；二是要充分发挥“追高线、促发展”的积极作用，结合ICH指导原则要求，运用现代管理工具推进变更分级管理，以高标准引领产业升级；三是要努力提升注册研究能力，鼓励研发生产企业积极采用eCTD格式进行注册申报，进一步提高注册申报资料质量，加快与国际先进模式接轨。　　国家药监局药审中心调研组还听取了企业在药品上市后变更中遇到的具体问题，并对重点问题进行了解答，有效回应了企业诉求。

“橘络配方颗粒”省级中药标准，标准编号为PFKLBZ-285-2023，已于2023年4月21日正式发布。根据企业反馈意见，经我局征求相关企业同意，并组织专家审定，现对该标准【制法】项进行勘误。“取橘络饮片6600g”更正为“取橘络饮片6700g”。现予以公示，公示期为1个月。公示期间，相关单位或个人如对公示内容有异议，请将书面意见反馈至指定电子邮箱。联系人：任兴德   联系电话：0931-7617410电子邮箱：gsmpazcc@163.com                             甘肃省药品监督管理局                             2025年7月21日   

根据《药品标准管理办法》《中药标准管理专门规定》，按照《中药配方颗粒质量控制与标准制定技术要求》《甘肃省药品监督管理局关于进一步规范省级中药标准制修订工作的通知》，我局组织完成了醋五灵脂等19个甘肃省中药配方颗粒标准（第十批）的起草研究、复核和专家审核审定工作，现予以公示，公示期为1个月。公示期间，相关单位或个人如对公示内容有异议，请将书面意见反馈至指定电子邮箱。联系人：任兴德  联系电话：0931-7617410电子邮箱：gsmpazcc@163.com 附件: 1.醋五灵脂等19个甘肃省中药配方颗粒标准目录      2.醋五灵脂等19个甘肃省中药配方颗粒标准                           甘肃省药品监督管理局                              2025年7月21日醋五灵脂等19个甘肃省中药配方颗粒标准目录序号品种名称类别1醋五灵脂配方颗粒修订2莪术（广西莪术）配方颗粒修订3草豆蔻配方颗粒修订4醋莪术（广西莪术）配方颗粒修订5花椒（花椒）配方颗粒修订6五灵脂配方颗粒修订7草红藤配方颗粒制定8炒茺蔚子配方颗粒制定9炒蜂房配方颗粒制定10炒青葙子配方颗粒制定11刀豆配方颗粒制定12蜜升麻（兴安升麻）配方颗粒制定13木鳖子仁配方颗粒制定14山柰配方颗粒制定15舒筋草配方颗粒制定16铁苋菜配方颗粒制定17通草配方颗粒制定18鲜石斛（金钗石斛）配方颗粒制定19岩白菜配方颗粒制定

京市监发〔2025〕44号　　市市场监管执法总队，各区市场监管局，北京经济技术开发区商务金融局、综合执法局，市局机场分局，市局机关各处室:　　《北京市食品经营环节进货查验记录和销售记录工作规范》已经2025年第14次局长办公会通过，现予印发，请认真遵照执行。　　北京市市场监督管理局　　2025年7月21日北京市食品经营环节进货查验记录和销售记录工作规范　　第一条为进一步规范食品（含食品添加剂、食用农产品）经营环节进货查验记录和销售记录工作，督促食品经营者落实食品安全追溯主体责任，根据《中华人民共和国食品安全法》《中华人民共和国食品安全法实施条例》《食用农产品市场销售质量安全监督管理办法》等法律法规和国家标准规定，结合本市实际，制定本规范。　　第二条本市行政区域内的食品经营者进货查验记录和销售记录及其监督管理适用本规范。　　本规范所称的食品经营者包括食品销售经营者和餐饮服务提供者。　　第三条食品经营者应当依法建立食品安全追溯体系，履行进货查验记录和销售记录义务，如实记录并保存食品进货查验和销售等信息，保证食品可追溯。　　第四条食品经营者采购食品、食品添加剂，应当查验下列证明材料：　　（一）供货者资质证明　　供货者为生产者的，查验其营业执照、食品生产许可证或者小规模食品生产许可等资质证明文件。　　供货者为销售者的，查验其营业执照、食品经营许可证或仅销售预包装食品经营者备案信息表，或小食杂店备案卡等资质证明文件。　　供货者仅销售食品添加剂的，查验其营业执照。　　（二）合格证明文件　　查验生产者出具的食品出厂检验合格证，或第三方检验机构出具的检验合格报告等合格证明文件。　　采购进口食品的，查验海关部门出具的入境货物检验检疫证明等证明文件。　　采购特殊食品（保健食品、婴幼儿配方乳粉、特殊医学用途配方食品），还应查验特殊食品注册或者备案信息。　　（三）进货凭证　　供货者提供的销售凭证，如发票、出库单、销售单、销售者与供货者签订的食品采购协议，以及其他含有食品名称、规格、数量、销售日期以及供货者名称、地址、联系方式等信息的凭证。　　第五条食品经营企业、食品添加剂的经营者应当建立进货查验记录制度，如实记录食品、食品添加剂的名称、规格、数量、生产日期或者生产批号、保质期、进货日期以及供货者名称、地址、联系方式等内容，并保存本规范第四条所列相关证明文件及进货凭证。　　采购特殊食品的，还应当记录特殊食品注册证书或者备案凭证编号。　　第六条实行统一配送经营方式的食品经营企业，由总部统一进行进货查验记录的，所属各经营门店应当保存总部的配送清单，提供可查验相应凭证的方式。　　第七条从事食品批发业务的经营企业应当建立食品销售记录制度，如实记录批发食品的名称、规格、数量、生产日期或者生产批号、保质期、销售日期以及购货者名称、地址、联系方式等内容，并保存相关凭证。　　销售特殊食品的，还应当记录特殊食品注册证书或者备案凭证编号。　　第八条食品、食品添加剂的进货查验记录、销售记录和相关凭证保存期限不得少于产品保质期满后六个月；没有明确保质期的，保存期限不得少于二年。　　第九条食品经营者采购食用农产品，应当查验下列证明材料：　　（一）供货者资质证明　　供货者为食用农产品生产企业、农民专业合作社等生产者、收购者，或者其他食用农产品销售者的，查验其营业执照。　　供货者为种植养殖户等自然人的，查验其身份证。　　（二）产品质量合格凭证　　生产者或收购者出具的承诺达标合格证、供货者出具的自检合格证明、食品集中交易市场或第三方机构出具的检验合格报告等合格证明文件。　　采购按照规定需要检疫、检验的猪肉、牛肉、羊肉、鸡肉等畜禽产品，查验动物检疫合格证明。采购猪肉产品的，还应查验肉品品质检验合格证明。　　采购进口食用农产品，查验海关部门出具的入境货物检验检疫证明等证明文件。　　（三）进货凭证　　供货者提供的承诺达标合格证、销售凭证，如发票、出库单、销售单、销售者与供货者签订的食用农产品采购协议，以及其他含有食用农产品名称、数量、供货日期以及供货者名称、地址、联系方式等信息的凭证。　　第十条食品集中交易市场开办者应当与入场经营者签订食用农产品质量安全协议，列明违反食品安全法律法规规定的退市条款，并按照本规范第九条的规定查验入场食用农产品的进货凭证和产品质量合格凭证。对未签订食用农产品质量安全协议的经营者和无法提供进货凭证的食用农产品，不得进入市场销售。对无法提供产品质量合格凭证的，应当进行抽样检验或者快速检测，结果合格的，方可允许进入市场销售。　　鼓励市场开办者通过信息化方式对拟进入市场销售食用农产品实施预约入场，远程审核食用农产品的进货凭证和产品质量合格凭证，统一采集食用农产品进货、交易等数据信息，提升市场食品安全追溯能力。　　第十一条食用农产品销售者应当建立进货查验记录制度，如实记录采购的食用农产品名称、数量、进货日期以及供货者名称、地址、联系方式等内容，并保存本规范第九条所列相关证明文件及进货凭证。　　实行统一配送经营方式的食用农产品销售企业，对统一配送的食用农产品可以由企业总部统一建立进货查验记录制度，并保存进货凭证和产品质量合格凭证；所属各经营门店应当保存总部的配送清单，提供可查验相应凭证的方式。　　第十二条从事食用农产品批发业务的销售企业，应当建立食用农产品销售记录制度，如实记录批发食用农产品的名称、数量、进货日期、销售日期以及购货者名称、地址、联系方式等内容，并保存相关凭证。　　第十三条批发市场开办者应当向入场销售者提供包括批发市场名称、食用农产品名称、产地、数量、销售日期以及销售者名称、摊位信息、联系方式等项目信息的统一销售凭证，或者指导入场销售者自行印制包括上述项目信息的销售凭证，并监督销售者开具使用。　　第十四条食用农产品进货查验记录、销售记录和相关凭证保存期限不得少于六个月。　　第十五条食品经营者应当加强食品交付时的检查验收，重点对照实物查验相关证明材料是否相符，感官性状、保质期和标签标识等是否符合要求。对温度、湿度有特殊要求的食品，还应当查验贮存、运输温度、湿度等是否符合要求，冷冻食品有无解冻后再次冷冻情形。不符合规定要求的，食品经营者应当拒绝收货。　　第十六条鼓励食品经营者采用信息化手段如实采集、留存食品进货查验和销售等信息。　　食品经营者采用信息化手段采集、留存进货和销售信息的，视为履行了法律、法规、规章规定的相应进货查验记录、销售记录等义务，属地市场监管部门不得再要求其采用纸质方式履行相应义务。　　第十七条食品经营者履行了法定进货查验等义务，有充分证据证明其不知道所采购的食品不符合食品安全标准，并能如实说明其进货来源的，可以免予处罚，但应当依法没收其不符合食品安全标准的食品；造成人身、财产或者其他损害的，依法承担赔偿责任。　　第十八条本规范由北京市市场监督管理局负责解释。　　第十九条本规范自发布之日起施行。