FDA批准前检查（PAI）合规程序的关注点
FDA批准前检查（PREAPPROVAL INSPECTIONS）遵循的程序为7346.832，批准前检查是药品审批的重要步骤之一，其目的是保证药品申请中指定的生产商能够生产药物，并且提交的数据是准确和完整的，确保其CGMP的符合性。问：哪些生产场地通常会触发PAI检查的评估?Finished dosage manufacturers1、成品制剂生产厂家API manufacturers2、原料药生产厂家Finished dosage and API testing sites3、成品制剂和原料药检验现场Finished dosage manufacturers4、成品制剂生产厂家Primary packaging and labeling sites5、初级包装和贴签现场For animal derived APIs, the facility that performs the crude extraction6、进行动物源性原料药粗提物提取的生产现场
批准前检查的目的Inspection by Objective
There are four primary inspectional objectives for PAIs, each of which requires strategies that consider the concerns and potential risks identified during the IQA team’s application assessment and facility risk assessment:
PAI 有 4 种基本的检查目的，每种均需要考虑在 IQA 小组的申报资料审评期间所识别出的问题和潜在风险，以及工厂风险评估：
Objective 1: Readiness for Commercial Manufacturing.目的 1：商业化生产的准备情况Determine whether the establishment has a quality system that is designed to achieve sufficient control over the facility and commercial manufacturing operations.确定该场所是否具备质量体系，其设计可对工厂和商业化生产操作进行足够的控制。
Objective 2: Conformance to Application.目的 2：与申报资料的符合情况Verify that the formulation, manufacturing or processing methods; analytical (or examination) methods; and batch records are consistent with descriptions contained in the CMC section of the application. This may include CMC information relevant to exhibit batches, biobatches, other pivotal clinical batches, and the proposed commercial-scale process.核查配方、生产或加工方法、分析（或检查）方法、以及批记录是否符合申报资料的 CMC 部分所含描述。其中可包括与申报批次、生物等效性批次、其它临床批和所拟商业化规模工艺有关的 CMC 信息。
Objective 3: Data Integrity Audit.目的 3：数据完整性审计Audit and verify raw data at the facility that are associated with the product. This information can, among other things, help to authenticate the data submitted in the CMC section of the application as relevant, accurate, complete, and reliable for CDER assessment.审计和核查现场与产品有关的原始数据。这些信息可有助于认定申报资料中 CMC 部分所提交数据的真实性（如有关）、准确性、完整性和可靠性，供 CDER 评估。
Objective 4: Commitment to Quality in Pharmaceutical Development.目的 4：对药物开发质量的承诺Assess the pharmaceutical development program by evaluating the extent to which it is supported, defined, managed, and continuously assessed for its effectiveness as well as its use in supporting continual improvement of the PQS.通过评估药物开发被支持、定义、管理的程度，和持续评估其有效性的情况，及其在支持 PQS 持续改进中的用途对其进行评估。
NDA/ANDA 检查报告NDA/ANDA Inspection Reporting
Issuance of Form FDA 483签发 FDA483 表
Reportable observations from the inspection will be issued to the establishment on Form FDA 483, consistent with instructions in the IOM. Significant CGMP deficiencies pertaining to the products and significant instances of application nonconformances should be cited on Form FDA 483.
检查中发现的可报告缺陷会按 IOM 中指导在FDA 483 表中签发给工厂。与产品有关的严重 CGMP 缺陷和申报不符合的严重情形应在 FDA 483 表中列出。
Completion of the Establishment Inspection Report现场检查报告的完成
The inspection team prepares a narrative EIR per instructions in the IOM (Chapter 5). The EIR should be completed as follows:检查组根据 IOM 里的指导（第 5 章）起草叙述性 EIR。EIR 应按以下要求完成：1Organize the EIR’s Manufacturing/Design Operations section by the PAI objectives (as described in Part II of this compliance program).按 PAI 目的组织 EIR 的生产/设计操作部分（按本合规程序第二部分所述）2Briefly describe the responsibilities of the inspected firm in relation to the assigned application.简要描述受检公司与所指派申报资料有关的职责3Describe the manufacturing operations and summarize coverage provided during the inspection as described in this compliance program.说明生产操作，按本合规程序所述总结检查范围4
Address application-related inspectional concerns communicated by the IQA team with specific data, areas covered, citations, and discussion with management.说明 IQA 小组所沟通的与申报资料有关的关于特定数据、检查覆盖领域、引用条款以及与公司管理人员的沟通方面的检查关切
ORA 建议ORA Recommendations
ORA(Office of Regulatory Affairs) divisions either inspect the establishment named in an application or they perform a file review and provide a recommendation for the facility’s acceptability. Based on the outcome of the PAI, the ORA PAM uses Panorama to make an approve or a withhold recommendation.
ORA(药政事务办公室) 中心可检查申报资料中列出的场所，或者执行文件审核，然后提交该工厂是否可接受的建议。根据 PAI 的结果，ORA PAM 使用 Panorama 给出批准或不批准建议。
01Approve Recommendation批准建议The ORA PAM makes an approve recommendation if there are no significant issues that would adversely impact the establishment’s ability to perform its designated functions described in the application.如果没有对该场所执行其在申报资料中指定职能的能力产生不良影响的重大问题，ORA PAM 则给出批准建议。
批准建议
02Withhold Recommendation不批准建议The ORA PAM makes a withhold recommendation if there are significant issues that would adversely impact the establishment’s ability to perform its designated functions described in the application.如果有对该场所执行其在申报资料中指定职能的能力产生不良影响的重大问题，ORA PAM 则给出不批准建议。
了解PAI的检查特点有助于医药企业更好地应对检查，提高药品质量和安全性，从而顺利获得FDA的批准。鸿翼医药作为生命科学行业合规专家，打通数据全生命周期管理，在满足国内外GxP规范的合规前提下，充分释放数据价值，赋能行业创新，助力生命科学行业数字化转型。
智慧质量一体化平台 GxP²® AI-Quality Suite鸿翼医药智慧质量一体化平台，是在鸿翼医药原有GxP²® Quality Suite的基础上，结合鸿翼医药InWise人工智能平台能力，打造的GxP²® AI-Quality Suite。通过AI能力的加持，让系统可以学习法规指南、企业SOP、内部知识库的等各类结构化甚至非结构化数据，提供法规智能问答、智能审核、智能写作等具有跨越式升级的解决方案。
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