Global Product Development Health SOP009878
全球产品开发健康 SOP009878

The content of this document, and any associated materials, is intended for Reckitt use only and may only be shared externally if a suitable confidentiality agreement is in place.
本文档的内容以及任何相关材料仅供 Reckitt 使用，并且只有在签订了适当的保密协议的情况下才能与外部共享。

Purpose
目的

The purpose of this document is to define the process for Product Development within the Reckitt Health business unit, to establish the minimum expectations and ensure that a consistent and risk-based approach is applied.
本文件的目的是定义 Reckitt Health 业务部门内的产品开发流程，确定最低期望值，并确保应用一致且基于风险的方法。

Scope
范围

The scope of product development covers both innovation and base-business or existing product changes:
产品开发范围既包括创新，也包括基础业务或现有产品变更：

Innovations
创新: 

New Product Development (NPD)
新产品开发 （NPD）,

Existing Product Development (EPD)
现有产品开发 （EPD）,

Business Development Initiatives (BDI)
业务发展倡议 （BDI）,

Net Revenue Growth (NRG) projects (Innovation projects within R&D Operations).
净收入增长（NRG）项目（研发运营中的创新项目）。

Base Business/Existing Product changes:
基本业务/现有产品变更：

Net Revenue Protection (NRP)
净收入保护 （NRP）,

Gross Margin Expansion (GME) or Gross Margin Improvement (GMI) or X-Seed.
毛利率扩张 （GME） 或毛利率提高 （GMI） 或 X-Seed。

For innovation refer to the Global R&D Health Innovation Operating Model Procedure, SOP030749
有关创新，请参阅全球研发健康创新运营模式程序，SOP030749.

For base business/existing product changes, refer to the Global Health Base Business Operating Model Procedure, SOP030750
有关基础业务/现有产品的更改，请参阅全球健康基础业务运营模式程序，SOP030750.

It also covers the following classifications: Medical Device, Cosmetic, Licenced Medicine, Monographs, General Product, Quasi drug, FDA Over the Counter (OTC), Food Supplements, VMS (hybrid-approach – refer to additional detail in Out of Scope section 2.1), Surface Care, Detergents and Biocides
它还涵盖以下分类：医疗器械、化妆品、许可药品、专论、一般产品、准药品、FDA 非处方药 （OTC）、食品补充剂、VMS（混合方法 - 请参阅范围外第 2.1 节中的更多详细信息）、表面护理、洗涤剂和杀菌剂.

Depending on the type of project activities, the following procedures shall be followed for internal and external product development activities. The level of support and decision-making will vary based on the brands and is further defined within the procedures below. New brands and acquisitions shall follow these procedures where possible or justify where not appropriate and define in local procedure until fully integrated.
根据项目活动的类型，内部和外部产品开发活动应遵循以下程序。支持和决策的水平将因品牌而异，并在下面的程序中进一步定义。新品牌和收购应尽可能遵循这些程序，或在不适当的情况下进行论证，并在完全整合之前在当地程序中定义。

Out of scope:
超出范围：

Hygiene or Nutrition and Vitamins, except for Hybrid sites where the Quality Management System (QMS) is a combination of Health Relief/Wellness/Hygiene may follow this procedure using a risk-based approach and alignment with key stakeholders including relevant quality representative. VMS will follow the general principles and procedural requirements of this procedure with some key exceptions using a hybrid, risk-based approach, refer to Appendix 1. VMS BU specific procedure will take precedent where applicable.
卫生或营养和维生素，但质量管理体系 （QMS） 是健康救济/保健/卫生相结合的混合工厂除外，可以使用基于风险的方法遵循此程序，并与主要利益相关者（包括相关质量代表）保持一致。 VMS 将遵循此程序的一般原则和程序要求，但一些关键例外情况使用混合的、基于风险的方法，请参阅附录 1。在适用的情况下，VMS BU 的特定程序将优先适用。

Scoping and other ‘pre-IDB’ activities are outside the scope of this procedure.
范围界定和其他“美洲开发银行前”活动不在此程序的范围之内。

Technology Transfer process is described in the Global Technology Transfer Policy and Procedure POL000147 and SOP010090
《全球技术转让政策和 程序》规定了技术转让进程POL000147和SOP010090.

Embellishment activities refer to Global Embellishment Procedure – Health, POL000060.
Embellishment activities 是指全球修饰程序 – 健康，POL000060。

Process Overview

The process overview in Figure 1 on the following page illustrates the end-to-end process and stagegates for Innovation Operating Model (defines process for NPD) for Reckitt Health products. The stages are described in Global R&D Health Innovation Operating Model Procedure, SOP030749
下页图 1 中的流程概述说明了 Reckitt Health 产品的创新运营模式（定义 NPD 流程）的 端到端流程和阶段门。全球研发健康创新运营模式程序中描述了这些阶段，SOP030749.

The R&D Operations lifecycle forms part of the Innovation Product Life Cycle under “Maintain and optimise Product” as shown in figure 1 on the following page. This illustrates the end-to-end process and stagegates for Base Business Operating Model (defines process for EPD) for Reckitt Health products. The stages are described in Global Health Base Business Operating Model Procedure, SOP030750
研发运营生命周期是“维护和优化产品”下的创新产品生命周期的一部分，如下页的图1所示。 这说明了利洁时健康产品的基本业务运营模式（定义 EPD 的流程）的端到端流程和阶段门。全球健康基础业务运营模式程序中描述了这些阶段，SOP030750. 

Figure 1 –Health Innovation and R&D Operations Base Product Lifecycle processes overview
图 1 – 健康创新和研发运营基础产品生命周期流程概述  

Note: Throughout the end-to-end process and stagegates for both operating models it is mandatory to follow the Global Technology Transfer Procedure, SOP010090 and Global R&D Health Risk Management Procedure, SOP008527.
注意：在两种运营模式 的端到端流程和阶段门中，都必须遵循全球技术转让程序、SOP010090和全球研发健康风险管理程序，SOP008527。

The deliverables required throughout the product development process can vary depending on the risk associated with the product classification or the Operating Model being followed. A series of ‘Deliverable Matrices’ have been developed, which provide a product classification-based framework for the development process refer to Appendix 1 – Project Deliverable Matrices.
在整个产品开发过程中所需的可交付成果可能会有所不同，具体取决于与产品分类相关的风险或所遵循的运营模式。已经开发了一系列“可交付成果矩阵”，为开发过程提供了一个基于产品分类的框架，请参阅附录 1 – 项目可交付成果矩阵。  

Within the Project Deliverable Matrices defined in Appendix 1 – Project Deliverable Matrices the product development lifecycle is broken down in the following stages: Feasibility, Development Strategy, Development Phase, Pre-Launch Phase, Launch Phase and Post Launch refer to section 4.4.
在附录 1 – 项目可交付成果矩阵中定义的项目可交付成果矩阵中，产品开发生命周期分为以下阶段：可行性、开发策略、开发阶段、发布前阶段、发布阶段和发布后，请参阅第 4.4 节。

NOTE: Any classifications undefined may use the overall matrix to determine their requirements. Where a Business Development Initiative (BDI) impacts upon the product claims then the project must follow the relevant deliverables matrix. Non-claims related BDI’s refer to local procedures. 
NOTE：任何未定义的分类都可以使用整体矩阵来确定其要求。如果业务发展计划 （BDI） 对产品声明产生影响，则项目必须遵循相关的可交付成果矩阵。与索赔无关的BDI是指当地程序。 

Process
过程

For full detail of required activities and deliverables for both the Health Innovation Operating Model and Health Base Business Operating Model refer to the relevant procedure below:
有关健康创新运营模式和健康基础业务运营模式所需活动和可交付成果的完整详细信息，请参阅下面的相关程序： 

Global R&D Health Innovation Operating Model Procedure, SOP030749. 
全球研发健康创新运营模式程序，SOP030749。  

Global Health Base Business Operating Model Procedure, SOP030750. 
全球健康基础业务运营模式程序，SOP030750。  

Appendix 1 – Project Deliverable Matrices.
附录 1 – 项目可交付成果矩阵。

General requirement defined below in section 4.3 are appliable to both the Health Innovation Operating Model and Health Base Business Operating Model
下文 第 4.3 节中定义的一般要求 适用于健康创新运营模式和健康基础业务运营模式.

Training Programme
培训计划

For training requirements refer to the individual procedures defined below:
有关培训要求，请参阅下面定义的各个程序：

Global Product Development – Health, SOP009878.
全球产品开发 – 健康、SOP009878。

Global R&D Health Innovation Operating Model Procedure, SOP030749
全球研发健康创新运营模式程序，SOP030749.

Global Health Base Business Operating Model Procedure, SOP030750
全球健康基础业务运营模式程序，SOP030750.

Roles & Responsibilities
角色和职责

All individuals contributing to work on a project within the scope of this procedure and applicable stages must comply with this procedure.
在本程序范围内和适用阶段内参与项目工作的所有个人都必须遵守本程序。

Innovation: Project Champion/Sponsor is a member of the Marketing function, responsible for collating project requirements based on consumer and market needs and communicating these to the project team, for example through regular contact & the Innovation Development Brief (IDB) and Maintenance Brief (MB) The Project Champion works together with the Project Manager to combine commercial and technical expertise.
创新：项目冠军/发起人是营销职能部门的成员，负责根据消费者和市场需求整理项目需求，并将其传达给项目团队，例如通过定期联系和创新发展简报（IDB）和维护简报（MB）项目冠军与项目经理合作，将商业和技术专长结合起来。

Base Business: Project Initiator/ Requester is responsible for initiating a project when a change to an existing product is required though the use of Maintenance Brief (MB). For example, the Project Initiator/ Requester could be Supply, Marketing, R&D, Global Regulatory.
基础业务：项目发起人/请求者负责在需要通过使用维护简报 （MB） 对现有产品进行更改时启动项目。 例如，项目发起人/请求者可以是供应、营销、研发、全球研发部门。

Portfolio & Program Management (PPM) Project Manager or Technical Project Lead (TPL)
投资组合和项目管理 （PPM） 项目经理或技术项目主管 （TPL）  

Depending on the type of project and scope, it will be lead by either a Project Manager from the PPM organisation or a Technical Project Lead.
根据项目的类型和范围，它将由 PPM 组织的项目经理或技术项目负责人领导。

Understands project requirements based on the IDB or MB.
了解基于 IDB 或 MB 的项目要求。

Responsible for prioritisation and controlling appropriate timings of product development and associated project risks, with communication of discrepancies against plan and escalation as required.
负责确定优先级并控制产品开发的适当时间安排和相关项目风险，并根据需要传达与计划的差异和上报。

Responsible for ensuring governance and compliance of the project.
负责确保项目的治理和合规性。

Responsible for the coordination of activities for supporting functions to ensure technical delivery of the product is in accordance with the project timelines.  In addition, the development timelines should consider Quality by Design (QbD) requirements refer to section 4.4 and project complexity.
负责协调支持功能的活动，以确保产品的技术交付符合项目时间表。  此外，开发时间表应考虑质量源于设计 （QbD） 要求，参见第 4.4 节和项目复杂性。

Accountable for obtaining cross-functional input to Stagegate Documents.
负责获取对 Stagegate 文档的跨职能输入。

Accountable and responsible for the end-to-end project management and planning. In addition, have the required authority to influence and discuss with the R&D Lead team. 
负责并负责端到端的项目管理和规划。此外，具有影响研发领导团队并与之讨论所需的权限。

Responsible for defining the success criteria and risk for a project with cross functional input to ensure full cycle.
负责定义项目的成功标准和风险，并具有跨职能的输入，以确保整个周期。

Responsible for handing over from one team to another where executions/implementation responsibilities are transferred for example R&D Operations to Supply Activity Management
负责从一个团队移交给另一个团队，其中执行/实施责任被转移，例如，研发运营到供应活动管理

Team accountabilities and responsibilities for Innovation are listed below in Table 1:
表 1 列出了团队对创新的问责制和责任：

Table 1 – Other Team Accountabilities and Responsibilities for Innovation
表 1 – 其他团队创新责任和责任 

Team accountabilities and responsibilities for Base Business/Existing Product Changes are listed below in Table 2:
表 2 列出了基础业务/现有产品变更的团队责任和职责：

Table 2 – Other Team Accountabilities and Responsibilities for Base Business/Existing Product Changes
表 2 – 基础业务/现有产品变更的其他团队责任和职责 

NOTE: Once project scope is locked, clearly defined RACI (Responsible, Accountable, Consult and Inform) required for end-to-end project responsibilities (including individual functional lead) and prioritisations for all resources, and base timeline reviewed. Consideration must also be given as whether this should be re-routed through R&D lead Team and who is responsible for escalation.
NOTE：一旦锁定了项目范围，就需要明确定义的端到端项目职责（包括个人职能领导）所需的 RACI（负责、负责、咨询和通知）和所有资源的优先级，并审查基线时间表。还必须考虑是否应该通过研发领导团队重新安排，以及谁负责升级。

General requirements
一般要求

Applicability
适用性

Each product development project shall assess on a risk-basis if certain stages or deliverables in the process are not appropriate to the project or may be required at a different point. These decisions should be justified and documented appropriately. For example, certain projects may not require a dedicated feasibility stage or discrete development stages. Ref to the Global R&D Health Risk Management Procedure, SOP008527
如果过程中的某些阶段或可交付成果不适合项目，或者可能在不同的时间点需要，则每个产品开发项目都应以风险为基础进行评估。这些决定应该有充分的理由，并有适当的记录。例如，某些项目可能不需要专门的可行性阶段或离散的开发阶段。参考全球研发健康风险管理程序，SOP008527. 

Project Management
项目管理

Projects should be initiated with cross functional kick-off meetings to ensure adequate awareness and understanding. The responsibilities of the cross functional team, to include ownership of the development, must be defined at the start of the project.
项目应通过跨职能的启动会议启动，以确保充分的认识和理解。跨职能团队的职责，包括对开发的所有权，必须在项目开始时定义。 

Traceability of decisions
决策的可追溯性

Project Managers should maintain a record of key decisions made throughout the project. The formality of the documentation should be commensurate to the level of risk associated with the project for example, project meeting minutes, trackers, etc. Overall, the project team should be able to retroactively confirm what key decisions were made, with the rationale as appropriate and documented using change control and risk assessments.
项目经理应保留在整个项目中做出的关键决策的记录。文档的格式应与项目相关的风险水平相称，例如，项目会议纪要、跟踪器等。总体而言，项目团队应该能够追溯确认做出了哪些关键决策，并酌情说明理由，并使用 变更控制和风险评估进行操作。 

Sustainability
可持续性

All projects must consider and understand the environmental impact of the full lifecycle of the products that are developed, covering origin of materials through to final use and disposal. A Sustainable Innovation Calculator (SIC) must be produced and completed for all NPD/EPDs. Exceptions are allowed for projects that will not have an impact on the sustainability score for example, artwork changes, fragrance/colour changes).  Exceptions should be aligned with the Sustainability team. The SIC should be completed as early in the Product development process as possible and help drive key project decisions. For access and training refer to the Sustainability team (Reckitt Calculator@Reckitt.com). Any exceptions shall be documented within change control for example product launch change control
所有项目都必须考虑并理解所开发产品的整个生命周期对环境的影响，包括材料的来源到最终使用和处置。必须为所有NPD/EPD制作并完成可持续创新计算器（SIC）。对于不会对可持续性分数产生影响的项目，例如，艺术品变更、香味/颜色变更，允许有例外。 例外情况应与可持续发展团队保持一致。SIC 应尽可能早地在产品开发过程中完成，并帮助推动关键项目决策。如需访问和培训，请咨询可持续发展团队 （Reckitt Calculator@Reckitt.com）。 任何变更都应记录在变更控制中，例如，产品发布变更控制.

Restricted Substances
限用物质

All product development must be managed in compliance with the requirements of the Restricted Substances List Policy, POL000032
所有产品开发都必须按照限用物质清单政策的要求进行管理，POL000032.

Safety & Regulatory Requirements
安全和监管要求

All formulation and development will be carried out in accordance with health & safety and consumer safety requirements, both external and internal. Furthermore, many of Reckitt’s categories develop products that are governed by specific legislative frameworks, which clearly establish the precise data and standards to be attained.
所有配方和开发都将根据外部和内部的健康与安全以及消费者安全要求进行。此外，利洁时的许多类别开发的产品都受特定立法框架的约束，这些框架明确规定了要达到的精确数据和标准。

It is Reckitt policy that all relevant and local regulations will be always followed for intended markets.  In addition, during product development projects, if there are any changes to supply markets, this MUST lead to re-review of the regulatory strategy given in the IDB (refer to Creation and Maintenance of Regulatory Health Strategies, SOP016144
利洁时的政策是，针对目标市场，将始终遵循所有相关和当地法规。  此外，在产品开发项目期间，如果供应市场发生任何变化，这必须导致重新审查美洲开发银行中给出的监管策略（请参阅《监管健康策略的创建和维护》，SOP016144.

E-commerce (E-Com)
电子商务 （E-Com）

All development projects shall consider the approach for E-commerce, this includes defining a functional E-Com readiness pack, or timescales for readiness at a minimum, as part of the Launch Recommendation refer to the Global eRB Quality Policy, POL000035
所有开发项目都考虑了电子商务的方法，这包括定义一个功能性的电子商务准备包，或至少准备的时间尺度，作为启动建议的一部分，请参阅全球电子商务质量政策，POL000035.

Local & Functional SOPs
本地和功能性SOP

If required, groups or sites developing, and/or providing support for the development of products for Health Brands shall implement procedures to describe specific applications of this standard or to define supporting processes, for example requirements for Medical Devices refer to Global Medical Device Manual, POL000157
如果需要，开发和/或为健康品牌产品开发提供支持的团体或站点应实施程序来描述本标准的具体应用或定义支持过程，例如，医疗器械的要求参见《全球医疗器械手册》POL000157 .

Local Brands
本地品牌

Local brands must also follow the Innovation Operating Model, however, the approval forum is regional meetings not the CLT meetings. Refer to the Global R&D Health Innovation Operating Model Procedure, SOP030749 for further information.
本土品牌也必须遵循创新运营模式，但是，审批论坛是区域会议，而不是CLT会议。 请参阅全球研发健康创新运营模式程序，SOP030749了解更多信息。

Intellectual Property (IP)
知识产权 （IP）

Shall be managed effectively to protect Reckitt both in terms of Reckitt knowledge and prevention of infringement of third-party IP in cooperation with the Trademarks, Patents and Legal departments. Further information on the steps undertaken to ensure the correct management of third-part IP or sensitive documents can be found in Global Technical Due Diligence Procedure, SOP008528
应与商标、专利和法律部门合作，在利洁时知识和防止侵犯第三方知识产权方面进行有效管理，以保护利洁时。有关为确保正确管理第三方知识产权或敏感文件而采取的措施的更多信息，请参阅全球技术尽职调查程序，SOP008528.

Product Development Lifecycle
产品开发生命周期

The purpose of the Development stage is to establish safe, effective, and quality products that can be industrially manufactured, distributed, and marketed. This is achieved by developing the product formula and delivery systems (i.e., packaging) and completing consumer and/or clinical studies and/or toxicological studies, venting/pressurization studies and/or scientific performance tests as appropriate to validate the product meets the intended consumer experience and substantiates the claims.
开发阶段的目的是建立安全、有效和优质的产品，这些产品可以在工业上制造、分销和营销。这是通过开发产品配方和输送系统（即包装）并完成消费者和/或临床研究和/或毒理学研究、透气/加压研究和/或科学性能测试（如适用）来实现的，以验证产品满足预期的消费者体验并证实声明。

For the completion of consumer and/or clinical studies refer to the below procedures:
为了完成消费者和/或临床研究，请参阅以下程序： 

Clinical Trials Policy, POL000057
临床试验政策，POL000057.

Compliance: Release of Batches for Clinical Trial use, 10465.
合规性：临床试验使用批次的发布，10465。

Overall Process for R&D Sensory and Consumer Testing within Health, SOP005952.
健康领域研发感官和消费者测试的整体过程，SOP005952。

Global Release Procedure for R&D Health and Hygiene Products and Studies SOP028389.
研发健康和卫生产品的全球发布程序和研究 SOP028389.

For guidance regarding developing successful packaging with mechanical Post-Consumer Recycled (PCR) resin to be used in Health products refer to PCR Development Approval - Global Requirements, SOP003708
有关使用机械消费后回收 （PCR） 树脂开发成功包装以用于保健产品的指南，请参阅 PCR 开发批准 - 全球要求，SOP003708.

All developed products must be safe and stable throughout their lifecycle as defined in the success criteria (i.e., Shelf life / Product life). This will be achieved by:
所有开发的产品必须在其成功标准（即保质期/产品寿命）中定义的整个生命周期内安全稳定。这将通过以下方式实现：

Establishing clear product function for consumer use,
建立明确的产品功能供消费者使用，

Designing out potential for consumer misuse or minimising as far as possible,
设计出消费者误用的可能性或尽可能减少滥用，

Establishing formula and pack compatibility,
建立配方和包装的兼容性，

Establishing product shelf life through stability and functionality testing, appropriate to the intended markets. Product functionality must be confirmed throughout the term of any stability testing. Refer to Global Stability Procedure – Health, SOP004293 and Guidelines to the Compatibility and Long-Term Stability Testing of Aerosol Products, SOP008796
通过稳定性和功能性测试确定产品保质期，适合目标市场。在任何稳定性测试的整个期限内，必须确认产品功能。请参阅全球稳定性程序 - 气 雾剂产品的兼容性和长期稳定性测试的健康、SOP004293和指南，SOP008796.

NOTE:
NOTE：

All developed products must have documented and robust test methods, which are validated or verified as appropriate to ensure they provide accurate, reproducible, and precise test results in line with Quality by Design (QbD) principles and guidelines. Refer to the following procedures:
所有开发的产品都必须具有记录在案且稳健的测试方法，这些方法经过适当的验证或验证，以确保它们提供准确、可再现和精确的测试结果，符合质量源于设计 （QbD） 原则和指南。请参阅以下步骤：

Procedure: Analytical Sciences Laboratory Method Development Guidelines, SOP013042
程序：分析科学实验室方法开发指南，SOP013042.

Procedure: Validation of Analytical Sciences Laboratory Methods, SOP011636
程序：分析科学实验室方法的验证，SOP011636.

Procedure: Analytical Sciences Laboratory Method Transfer, SOP009376
程序：分析科学实验室方法转移，SOP009376.

Similarly, all items must have documented specifications, to ensure consistent and adequate product quality, which delivers the intended consumer experience. Refer to the following procedures:
同样，所有商品都必须有记录在案的规格，以确保一致和足够的产品质量，从而提供预期的消费者体验。 请参阅以下步骤：

Preparation, Review, Approval and Revision of Raw Material and Formulation Documents, SOP017169
原材料和制剂文件的编制、审查、批准和修订，SOP017169.

Preparation, Review, Approval and Revision of TDS Test Method Documents, SOP003578
TDS测试方法文件的准备、审查、批准和修订，SOP003578.

Feasibility
可行性 

Early on, during the feasibility development stage, final target product profile is to be established for the project in line with QbD principles and guidelines, to include design, formulation, physical chemical attributes (colour, density, hardness, Flash point, melting and boiling points etc.) and fragrance & flavour development. 
在早期，在可行性开发阶段，将根据QbD原则和准则为项目确定最终目标产品概况，包括设计，配方，物理化学属性（颜色，密度，硬度，闪点，熔点和沸点等）以及香味和风味开发。 

For QbD principles and guidelines refer to Procedure/Compliance: Application of Quality by Design Philosophy and Procedures (QBD) SOP008877
F或 QbD 原则和指南是指程序/合规性：质量 by 设计理念和程序 （QBD） 的应用 SOP008877.

For fragrance & flavour development refer to Fragrance and Flavour Compliance Process, SOP007921
有关香精和香精开发，请参阅香精和香精合规流程，SOP007921.

For the completion of Organoleptic Assessment of Early Stage Feasibility Samples refer to R&D Organoleptic Assessment of Early Stage Feasibility Samples SOP005513.
有关完成早期可行性样品的感官评估，请参阅研发早期可行性样品的感官评估SOP005513。

The development phase also includes consumer safety initial assessment, which provides proof of product safety feasibility to aid in deciding to proceed with further testing refer to GSA Safety: Safety Assessments, SOP016108. In addition, ensure the concept of eCommerce product design is assessed at the feasibility stage, refer to the Global eRB Quality Policy, POL000035.
开发阶段还包括消费者安全初步评估，该评估提供产品安全可行性证明，以帮助决定继续进行进一步测试，请参阅 GSA 安全：安全评估SOP016108。 此外，为了确保在可行性阶段对电子商务产品设计的概念进行评估，请参阅全球 eRB 质量政策，POL000035。

In addition, for key project deliverables refer to Appendix 1 - Project Deliverables Matrices.
此外，对于关键项目可交付成果，请参阅附录 1 - 项目可交付成果矩阵。 

Development Strategy 
发展战略 

The purpose of this phase is to define and confirm the strategies to support the project. The individual functional strategies should be reviewed to cross-functionally align on the overall strategic approach of the project and to avoid potential conflicts or issues. This may be documented as required for example project meeting minutes, specified templates, ‘Project Approach’ document, etc.).  For key project deliverables refer to Appendix 1 - Project Deliverables Matrices.
此阶段的目的是定义和确认支持项目的策略。应审查各个职能策略，以在跨职能上与项目的整体战略方法保持一致，并避免潜在的冲突或问题。这可以根据需要记录下来，例如项目会议记录、指定的模板、“项目方法”文档等）。  有关关键项目可交付成果，请参阅附录 1 - 项目可交付成果矩阵。 

As part of the development strategy, all product claims and success criteria must be agreed at the beginning of each project, which must detail:
作为开发战略的一部分，所有产品声明和成功标准必须在每个项目开始时达成一致，其中必须详细说明： 

What will be claimed (i.e., on packs, in advertising, etc.),
将要声明的内容（即，在包装上、广告中等）， 

The competitive product the claim will be benchmarked against (where applicable),
索赔将作为基准的竞争产品（如适用）， 

How the claim will be substantiated and the acceptance criteria,
索赔将如何得到证实以及接受标准， 

Key risks and mitigation plan,
主要风险及缓解预案， 

Overall, the product should meet the requirements outlined in the IDB and MB.
总体而言，该产品应满足 IDB 和 MB 中列出的要求。 

The strategy for product validation and qualification will be defined as part of the Product Design Criteria (PDC). This is a key document for identifying product claims and associated risks, support strategy, key product attributes, and the success criteria. The PDC must be updated and re-approved through the development process refer to the following. 
产品验证和资格认证策略将被定义为产品设计标准（PDC）的一部分。这是一份关键文档，用于识别产品声明和相关风险、支持策略、关键产品属性和成功标准。PDC必须通过开发过程进行更新和重新批准，请参阅以下内容。 

Medical Device products refer to Design Control-Medical Devices, SOP011284
医疗器械产品是指外观设计控制-医疗器械，SOP011284.

Process for all other Health products refer to Process: Product Design Criteria – Process and Procedure for Completing the PDC Document, SOP004659
所有其他健康产品的流程请参阅流程：产品设计标准 - 完成 PDC 文件的过程和程序，SOP004659.

Process for confirming substantiation of the claims described in the PDC refer to Process: Claims Memo – Procedure for Completing the Document SOP008905
PDC中描述的声明确凿的确认程序请参阅流程：索赔备忘录 - 完成文件的程序SOP008905.

Development
发展 

The final design or formulation of the product should be agreed as part of the key stagegates for each of the operating models to prevent deviation from the original scope and design, along the project development process by providing a firm point of reference. It can also support justification for resource allocation, device tooling or formula ingredients. The level of formality of a product lock down should be commensurate to the level of risk associated with the product being developed and agreed as appropriate with project stakeholders in line with the relevant operating model.
产品的最终设计或配方应作为每个运营模型的关键阶段门的一部分达成一致，以防止在项目开发过程中偏离原始范围和设计，通过提供一个坚实的参考点。它还可以支持资源分配、设备工具或配方成分的合理性。产品锁定的正式程度应与与正在开发的产品相关的风险水平相称，并应根据相关运营模式与项目利益相关者达成一致。

For a breakdown of the project development phase for each product classification refer to Appendix 1 - Project Deliverables Matrices.
有关每种产品分类的项目开发阶段的细分，请参阅附录 1 - 项目可交付成果矩阵。 

As part of product development, it is mandatory to complete evaluations for Q3D Elemental Impurities, Nitrosamines and Dual Quality. Refer to the specific procedures below:
作为产品开发的一部分，必须完成对 Q3D 元素杂质、亚硝胺和双重质量的评估。 请参考以下具体步骤：

Global R&D Health Nitrosamines Evaluation Procedure, SOP005624
全球研发健康亚硝胺评估程序，SOP005624.

Procedure / Compliance: Q3D Elemental Impurities Evaluation, SOP011371
程序/合规性：Q3D 元素杂质评估，SOP011371.

Dual Quality Procedures, SOP016987
双重质量程序，SOP016987.

During in the final stages of product development all physical and digital elements of the product and approve the validation of a safe, quality, and effective product. A key requirement of this phase is the development of a laboratory scale preparation that is capable of reliably producing on a small scale and a representative method of manufacture. Guidance for process validation refer to the Global Qualification and Validation Procedure – Health, SOP006754 Additional details for Non-licenced Health refer to Process: Non-Licensed Health - Process Validation, SOP011072
在产品开发的最后阶段，对产品的所有物理和数字元素进行验证，并批准对安全、质量和有效产品的验证。这一阶段的一个关键要求是开发一种实验室规模的制剂，该制剂能够在小规模上可靠地生产，并具有代表性的制造方法。流程验证指南请参阅全球资格认证和验证程序 - 健康SOP006754 非许可健康的其他详细信息请参阅流程：非许可健康 - 流程验证SOP011072 .

NOTE:
注意：

If validation requirements cannot be achieved within the current project plan, this must be escalated to Category Lead Team (CLT) to agree next steps.
如果在当前项目计划中无法实现验证要求，则必须将其上报给类别领导团队 （CLT） 以商定后续步骤。 

These activities are required to be documented in line with the relevant stages of the Global Technology Transfer Procedure, SOP010090
这些活动必须根据全球技术转让程序的相关阶段进行记录，SOP010090.

During the product development lifecycle for the generation, review, and approval of on-pack final marketing materials (printed artworks) refer to the Global Artwork Procedure SOP009213. Likewise for any off-pack advertising and promotional materials refer to Global Health and Nutrition Off-Pack Advertising, Promotional and Other Communication Materials Procedure, SOP006955
在产品开发生命周期中，包装上的最终营销材料（印刷艺术品）的生成、审查和批准均参考全球艺术作品程序SOP009213。 同样，对于任何包装外的广告和促销材料，请参阅全球健康和营养包装外广告、促销和其他传播材料程序，SOP006955.

Pre-launch, Launch Phase and Post Launch
发布前、发布阶段和发布后

For a breakdown of the project development phase for each product classification refer to Appendix 1 - Project Deliverables Matrices. In addition, include the review of any assessment findings with regards to eCommerce.
有关每种产品分类的项目开发阶段的细分，请参阅附录 1 - 项目可交付成果矩阵。 此外，还包括对与电子商务有关的任何评估结果的审查。

Suppliers & Development Partners
供应商和开发合作伙伴

Third-parties shall be approved and managed in accordance with the requirements of the Global Supplier Management Procedure, SOP012135 and Global R&D Health Technical Quality Agreement Procedure, SOP006147. The necessary applicable Legal agreements required to be approved by both the third-party and relevant Reckitt responsible personnel must be in place and should be approved prior to commencing development.
第三方应根据全球供应商管理程序、SOP012135和全球研发健康技术质量协议程序的要求进行批准和管理，SOP006147。 必须制定必要的适用法律协议，并须经第三方和利洁时相关负责人的批准，并应在开始开发之前获得批准。 

External Product Development
外部产品开发

For all third-party developed products, the Global Technical Due Diligence Procedure, SOP008528 should be followed to ensure all necessary deliverables will be produced and to a sufficiently high standard. Due Diligence can be applied to both the third-party themselves, as well as any products they develop or supply.  Non-disclosure Agreement (NDA) and Joint Development Agreements (JDAs) must be approved with third- party developers to ensure that the activities, timings, and responsibilities are clearly understood and aligned. The key data and documentation required to support the development must be clearly communicated to the third-party at the start of the process and verified by Reckitt. The level of Due Diligence activity and any associated mitigation actions may vary depending on the type of external development (i.e., products considered ‘Ready to Go’ (R2G) may require reduced activities). This must be assessed and documented on a risk basis for each project.
对于所有第三方开发的产品，应遵循全球技术尽职调查程序SOP008528，以确保生产出所有必要的可交付成果并达到足够高的标准。尽职调查既可以适用于第三方本身，也可以适用于他们开发或提供的任何产品。  保密协议 （NDA） 和联合开发协议 （JDA） 必须得到第三方开发者的批准，以确保清楚地理解和协调活动、时间和责任。支持开发所需的关键数据和文件必须在流程开始时清楚地传达给第三方，并由利洁时进行验证。尽职调查活动和任何相关的缓解措施的水平可能因外部开发的类型而异（即，被视为“准备就绪”（R2G） 的产品可能需要减少活动）。必须对每个项目进行风险评估和记录。

Document Control
文档控制

Documentation practices associated with product development shall follow the requirements of the Global R&D Health Standard Operating Procedure Creation and Revision Procedure, SOP013620
与产品开发相关的文档实践应遵循全球研发健康标准操作程序创建和修订程序的要求，SOP013620.

All technical documentation shall be published for development projects prior to manufacture using validated systems to create, approve, distribute, and publish specifications.  Refer to the following procedures for Technical Document System (TDS) and PLM (Optiva) document: 
在制造之前，应使用经过验证的系统创建、批准、分发和发布规格，为开发项目发布所有技术文档。  请参阅以下程序获取技术文档系统 （TDS） 和 PLM （Optiva） 文档： 

TDS:
TDS：

Preparation, Review, Approval and Revision of TDS Master Formulation Documents, SOP017169
TDS主制定文件的编制、审查、批准和修订，SOP017169

Preparation, Review, Approval and Revision of TDS Test Method Documents, SOP003578
TDS测试方法文件的准备、审查、批准和修订，SOP003578.

PLM (Optiva): For creation of technical documents in PLM refer to the listed PLM procedures in Section 9.0, References and SharePoint Site: PLM Program where full detailed guidance can be accessed.
PLM （Optiva）：有关在 PLM 中创建技术文档的信息，请参阅第 9.0 节 “参考资料”和 SharePoint 站点：PLM 程序中列出的 PLM 过程，其中可以访问完整详细的指南。

All key projects and StageGate documents for both Operating Models, except for Maintenance Briefs and associated documentation which may be managed in local systems. Where SyncForce is not in use (for example local projects), key project documents must be retained in, and retrievable from, a defined and controlled system.
两种运营模式的所有关键项目和 StageGate 文档，但可能在本地系统中管理的维护简报和相关文档除外。在不使用 SyncForce 的情况下（例如本地项目），关键项目文档必须保留在定义和受控的系统中，并可从中检索。

Change Management
变更管理

For NPDs, the process is supported procedurally, and Change Management may be required within, or as consequence of process. For example:
对于 NPD，该过程在程序上得到支持，并且可能需要在流程内部或作为流程的结果进行变更管理。例如：

For NPD’s Marketing own initiation of Change Controls for the Product Launch of the project and Supply sites/EMOs will require change control as part of the Global Technology Transfer process, SOP010090
对于NPD的营销部门来说，自己启动对项目产品启动的变更控制和供应站点/EMO将需要变更控制，作为全球技术转让过程的一部分，SOP010090.

For EPDs or Maintenance projects, the end-to-end project must also be supported by a Change Control record to capture all potential impacts of the changes to the existing product.
对于 EPD 或维护项目，端到端项目还必须得到变更控制记录的支持，以捕获变更对现有产品的所有潜在影响。

In an instance whereby a change control is not deemed to be needed this must be documented via risk assessment with cross functional input and approval as per the Global R&D Health Risk Management Procedure, SOP008527
在认为不需要变更控制的情况下，必须通过风险评估进行记录，并根据全球研发健康风险管理程序进行跨职能输入和批准，SOP008527.

Note: It is not recommended to use change management as a project management tool for the end-to-end management of central project.
注意：不建议将变更管理用作中心项目的端到端管理的项目管理工具。

Refer to the Change Control Roles and Responsibilities Matrix located on the Quality One, sharepoint site under change control section
请参阅位于 Quality One， sharepoint 站点的“更改控制”部分下的“更改控制角色和职责矩阵”.

Risk Management
风险管理

Managing risk is an essential and critical aspect of the product development process. The Reckitt Health R&D approach to risk management is defined in the Global R&D Health Risk Management Procedure, SOP008527
管理风险是产品开发过程中必不可少且关键的方面。利洁时健康研发风险管理方法在全球研发健康风险管理程序中定义，SOP008527.

NOTE: Any specific potential project risks and associated impacts are measured consistently and escalated accurately to R&D Lead Team for communication of resolution and or delay as required. 
注意：任何特定的潜在项目风险和相关影响都会得到一致衡量，并准确上报给研发领导团队，以便根据需要传达解决方案和/或延迟。  

Abbreviations

AP  Activation Pack
AP 激活包

CDO  Category development organisation
CDO 类别开发组织

CGD  Category Group Director
CGD 品类组总监

CLT  Category Lead Team
CLT 类别领导团队

E-Com  E-commerce
E-Com 电子商务

EMO  External Manufacturing Organisation
EMO 外部制造组织

EVP  Executive Vice President
执行副总裁 、执行副总裁

FDA  Food and Drug Administration
美国食品和药物管理局

GBMM   Global Brand Marketing Manager
GBMM 全球品牌营销经理

GCD  Global Category Director
GCD 全球品类总监

GSA  Global Safety Assurance
GSA 全球安全保证

I&A  Insights and Analytics
I&A 洞察和分析

IDB   Innovation Development Brief
美洲开发银行 创新发展简报

IP  Innovation Pack
知识产权 创新包

IP  Intellectual Property
知识产权

JDA  Joint Development Agreement; generated in iContract . An agreement between Reckitt and one or more parties who all agree to develop, for a finite time (and not usually for supply) a new asset or product
JDA 联合开发协议;在iContract中生成。利洁时与一方或多方之间的协议，这些各方都同意在有限的时间内（通常不是为了供应）开发新的资产或产品.

LR  Launch Reco
LR 推出 Reco

LtE  Licence to Explore
LtE 勘探许可证

MB  Maintenance Brief
MB 维护简介

NDA   Non-disclosure Agreement
保密协议

OTC  Over the Counter
场外交易 OTC 场外交易

PA  Project Approach
PA项目方法

PDC  Product Design Criteria (i.e., claims, success criteria, & associated risks)
PDC 产品设计标准（即声明、成功标准和相关风险）

PLM  Product Lifecycle Management (System such as TDS and Optiva)
PLM 产品生命周期管理（TDS 和 Optiva 等系统）

PPM  Portfolio and Project Management
PPM 投资组合和项目管理

Q3D  ICH Guideline for Elemental Impurities Q3D(R1)
Q3D ICH元素杂质指南Q3D（R1）

QbD  Quality by Design
QbD 质量源于设计

QMS  Quality Management System
QMS 质量管理系统 

R&D   Research and Development
研发研发

R2G  Ready to Go
R2G 蓄势待发

RACI   Responsible, Accountable, Consult and Inform
RACI 负责、问责、咨询和告知

RFA  Regulatory Formulation Assessment
RFA 监管制定评估

SIC  Sustainable Innovation Calculator
SIC 可持续创新计算器

SVP  Senior Vice President
高级副总裁 、高级副总裁、高级副总裁

SyncForce  System used for the approval of MB and IDB’s
SyncForce 系统用于批准MB和IDB

TG   Technical Go
TG 技术去

TPL  Technical Project Lead
TPL 技术项目主管

VMS  Vitamins Minerals & Supplements
VMS 维生素矿物质和补充剂

Product Development Project Abbreviations and definitions
产品开发项目缩写和定义

NPD - New Product Development
NPD - 新产品开发

New Category Entry – Innovation for new strategic platforms that fall outside the core business categories
新品类进入 – 针对核心业务类别之外的新战略平台进行创新.

New Segment Entry – Extend current brand portfolio into new segments/adjacencies or extension into new pricing tiers (e.g., super high premium)
新细分市场 – 将当前品牌组合扩展到新的细分市场/邻接区域，或扩展到新的定价层（例如，超高溢价）.

New Product Innovation – New Product Innovation against brand segments to include ingredient innovation that unlocks significant new claim territories and requires significant R&D/clinical resources
新产品创新 – 针对品牌细分的新产品创新，包括成分创新，这些创新开启了重要的新索赔领域，并需要大量的研发/临床资源.

Whitespace Geography / New Country Entry – Identifying multi-market strategic roll-out priorities, includes establishing business in new stages/segments/channels
空白地理/新国家进入 – 确定多市场战略推出优先事项，包括在新阶段/细分市场/渠道中建立业务.

EPD - Existing Product Development
EPD - 现有产品开发.

Formula Upgrade – Substantial upgrade to existing SKU that entails re-formulation (new chassis) for improved product performance/and enhanced claims/and reg. changes. Requires R&D or clinical support.
配方升级 – 对现有 SKU 的重大升级，需要重新配方（新底盘）以提高产品性能/并增强声明/和法规变更。需要研发或临床支持。 

Structural Packaging Upgrade – Structural packaging changes that are in-line Master brand Equity and provide financial advantage to business (e.g. incremental Net Revenue or improved Gross Margin %)
结构性包装升级 – 符合主品牌资产并为企业提供财务优势的结构性包装变更（例如，增加净收入或提高毛利率%） 

Strategic Platform Development – Development of new strategic fragrance / ingredients range across brand of formula harmonization
战略平台开发 – 开发新的战略性香料/成分系列，跨品牌配方协调.

Claims Upgrade – Claims that require significant R&D resource (new science, clinical support etc.), ideally with multi-regional applicability.
索赔升级 – 需要大量研发资源（新科学、临床支持等）的索赔，理想情况下具有多区域适用性。

New Flanker – Developed to replace an existing SKU on an agreed brand platform. It must be formulated using the available flavour bank and must meet supply complexity hurdles
New Flanker – 开发用于替换商定品牌平台上的现有 SKU。它必须使用可用的风味库进行配制，并且必须满足供应复杂性的障碍.

BDI – Business Development Initiative
BDI – 业务发展倡议.

Claims (for comms, digital, Point of Sale Materials) – Any claim that enhances perception of product performance and does not require re-formulation or R&D development (either for Region/Market). This includes competitive claims, mega range claims, or are stage of a new range behind different claim/positioning (but with same formula)
声明（针对通信、数字、销售点材料） – 任何增强产品性能感知且不需要重新配方或研发开发（针对地区/市场）的声明。这包括竞争性索赔、超大范围索赔，或者是不同索赔/定位（但公式相同）后面的新范围的阶段.

Packaging – new graphics – Non-structural, minor front of pack (FOP) artwork changes (that are in-line with Master brand Equity); cost to be funded locally
包装 – 新图形 – 非结构性、小的包装正面 （FOP） 艺术作品更改（与主品牌资产保持一致）; 费用由当地资助.

New sizes, promo and limited editions (pack configurations) – Sizing variation (in line with brand strategy) promotional pack variation (i.e., gadget colour), must be Gross Margin % accretive. 
新尺码、促销版和限量版（包装配置）– 尺码变化（符合品牌战略）促销包装变化（即小工具颜色），必须是毛利率百分比增加。  

NRG - Net Revenue Growth
NRG - 净收入：同比增长.

NRP - Net Revenue Protection
NRP - 净收入保护.

NR Erosion – Replacement of existing SKU (with new claim or benefit) to keep brand offering competitive or prevent loss of share. Any CEP/GXP/Quality; PR/Legal; Out of Stock/Out of Spec that will cause loss of net revenue, including Regulatory issues & RSL
NR 侵蚀 – 替换现有 SKU（具有新的索赔或利益），以保持品牌产品的竞争力或防止份额损失。任何 CEP/GXP/质量;公关/法律;缺货/不合格将导致净收入损失，包括监管问题和 RSL.

Business Continuity – Qualification of new raw material suppliers or sourcing sites to guarantee business continuity. They can present a cost saving element, but the main driver is not gross margin expansion
业务连续性 – 对新的原材料供应商或采购地点进行资格认证，以保证业务连续性。它们可以提供节省成本的元素，但主要驱动因素不是毛利率的扩张.

GME - Gross Margin Expansion
GME - 毛利率扩张.

Margin improvement – Increase profitability through modification of product or process or site
提高利润率 – 通过修改产品、流程或场地来提高盈利能力.

GMI - Gross Margin Improvement
GMI - 毛利率改善.

References
引用

External
外部

Eudralex Volume 4
Eudralex 第 4 卷

European Medicines Agency Guideline on Good Pharmacovigilance Practices
欧洲药品管理局良好药物警戒规范指南.

21 Code of Federal Regulations (CFR) parts.
21 联邦法规 （CFR） 部分。

World Health Organisation Good Manufacturing Practices
世界卫生组织良好生产规范.

ISO 22716 Cosmetics Good Manufacturing Practices
ISO 22716化妆品良好生产规范

Cosmetic Product Regulations (EC) No. 1223/2009
化妆品法规 （EC） 第 1223/2009 号

ICH Q8 Pharmaceutical Development
ICH Q8 药物开发

ICH Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
ICH Q12 技术与监管注意事项 f或药品生命周期管理

UK MDR 2002 Part II
英国 MDR 2002 第二部分

Medical Device Directive 93/42/EEC
医疗器械指令 93/42/EEC

Medical Device Regulation 2017/745
医疗器械法规 2017/745

BS EN ISO13485:2016+A11:2021 - Medical devices - Quality Management Systems – Requirements for Regulatory Purposes
BS EN ISO13485：2016+A11：2021 - 医疗器械 - 质量管理体系 - 监管要求

BS EN ISO 14971:2019+A11:2021 - Medical Devices - Application of Risk Management to Medical Devices
BS EN ISO 14971：2019+A11：2021 - 医疗器械 - 风险管理在医疗器械中的应用

Internal:
内部：

POL000103  Reckitt Quality Manual
POL000103 利洁时质量手册

POL000157 Global Medical Device Manual
POL000157 全球医疗器械手册

POL000060  Global Embellishment Procedure – Health
POL000060 全球修饰程序 – 健康

SOP030749 Global R&D Health Innovation Operating Model Procedure (and associated supporting documents)
SOP030749 全球研发健康创新运营模式程序（及相关支持文件）

SOP030750 Global Health Base Business Operating Model Procedure (and associated supporting documents)
SOP030750 全球健康基础业务运营模式程序（及相关证明文件）

SOP008527 Global R&D Health Risk Management Procedure
SOP008527 全球研发健康风险管理程序

POL000147 Global Technology Transfer Policy
POL000147 全球技术转让政策

SOP010090 Global Technology Transfer Procedure – Health
SOP010090 全球技术转让程序 - 健康

SOP013620 Global R&D Health Standard Operating Procedure Creation and Revision Procedure
SOP013620 全球研发健康标准操作程序的制定和修订程序

SOP012135 Global Supplier Management Procedure
SOP012135 全球供应商管理程序

SOP006147 Global R&D Health Technical Quality Agreement Procedure
SOP006147 全球研发健康技术质量协议程序

SOP008528 Global Technical Due Diligence Procedure
SOP008528 全球技术尽职调查程序

SOP004659 Process: Product Design Criteria – Process and Procedure for Completing the PDC Document
SOP004659流程：产品设计标准 – 完成 PDC 文件的过程和程序

SOP008905 Process: Claims Memo – Procedure for Completing the Document
SOP008905流程：索赔备忘录 - 填写文件的程序

SOP017169 Preparation, Review, Approval and Revision of Raw Material and Formulation Documents
SOP017169 原料药及制剂文件的编制、审查、批准和修订

SOP003578 Preparation, Review, Approval and Revision of TDS Test Method Documents
SOP003578 TDS试验方法文件的编制、审查、批准和修订

SOP008877 Procedure/Compliance: Application of Quality by Design Philosophy and Procedures (QBD)
SOP008877程序/合规性：质量源于设计理念和程序 （QBD） 的应用

SOP007921 Fragrance and Flavour Compliance Process
SOP007921香精和香精合规流程

POL000032 Restricted Substances List Policy
POL000032 限用物质清单政策

SOP011284 Design Control – Medical Devices
SOP011284 设计控制 – 医疗器械

SOP016108 GSA Safety: Safety Assessments
SOP016108 GSA安全：安全评估

SOP013042 Procedure: Analytical Sciences Laboratory Method Development Guidelines
SOP013042程序：分析科学实验室方法开发指南

SOP011636 Procedure: Validation of Analytical Sciences Laboratory Methods
SOP011636程序：分析科学实验室方法的验证

SOP009376  Procedure: Analytical Sciences Laboratory Method Transfer
SOP009376程序：分析科学实验室方法转移

SOP005624 Global R&D Health Nitrosamines Evaluation Procedure
SOP005624 全球研发健康亚硝胺评估程序

SOP011371 Procedure / Compliance: Q3D Elemental Impurities Evaluation
SOP011371程序/合规性：Q3D元素杂质评估

SOP016987 Dual Quality Procedures
SOP016987双重质量程序

POL000035 Global eRB Quality Policy
POL000035 全球 eRB 质量政策

SOP016144 Creation and Maintenance of Regulatory Health Strategies
SOP016144 制定和维护监管健康战略

SOP006754 Global Qualification and Validation Procedure – Health
SOP006754 全球资格认证和验证程序 – 健康

SOP011072 Process: Non-Licensed Health - Process Validation
SOP011072 流程：未经许可的健康 - 流程验证

SOP006955 Global Health and Nutrition Off-Pack Advertising, Promotional and Other Communication Materials Procedure
SOP006955 Global Health and Nutrition 包装外广告、促销和其他传播材料程序

SOP004293 Global Stability Procedure – Health
SOP004293 全球稳定程序——健康

SOP008796 Guidelines to the Compatibility and Long-Term Stability Testing of Aerosol Products
SOP008796 气雾剂产品的兼容性和长期稳定性测试指南

SOP005513 R&D Organoleptic Assessment of Early Stage Feasibility Samples
SOP005513 早期可行性样品的研发感官评估

POL000057 Clinical Trials Policy
POL000057临床试验政策

10465 SOP EU- Compliance:  Release of Batches for Clinical Trial Use
10465 SOP 欧盟合规性： 临床试验使用批次的发布

SOP005952 Overall Process for R&D Sensory and Consumer Testing within Health
SOP005952健康领域研发感官和消费者测试的整体流程

SOP028389 Global Release Procedure for R&D Health and Hygiene Products and Studies
SOP028389 研发健康和卫生产品及研究的全球发布程序

SOP009213 Global Artwork Procedure
SOP009213 全球艺术作品程序

PLM Procedures:
PLM 程序：

SOP010659 PLM Creation and Management of Raw Materials in Optiva
SOP010659 在 Optiva 中创建和管理原材料的 PLM

SOP013549 PLM Creation and Management of R&D Supplier Site Materials in Optiva
SOP013549 在Optiva中创建和管理研发供应商现场材料的PLM

SOP013550 PLM Creation and Management of Formulation Objects in Optiva
SOP013550 在 Optiva 中创建和管理配方对象的 PLM

SOP013551 PLM Creation and Management of Generic Product Assembly Objects in Optiva
SOP013551 在Optiva中创建和管理通用产品装配对象的PLM

SOP009270  PLM: Creation and Management of Method of Manufacture Document Objects in Optiva
SOP009270 PLM：在Optiva中创建和管理制造方法的文档对象

SOP014232 PLM Creation and Management of Specifications in Optiva
SOP014232 在 Optiva 中创建和管理规范的 PLM

SOP014233 PLM Creation and Management of R&D Test Methods in Optiva
SOP014233 在Optiva中创建和管理研发测试方法的PLM

SOP009937 PLM: Creation & Management of RFA Document Object in Optiva
SOP009937 PLM：在Optiva中创建和管理RFA文档对象

SOP009936 PLM: Creation and Management of Chemical Reaction in Optiva
SOP009936 PLM：在 Optiva 中创建和管理化学反应

SOP014225 PLM Creation and Management of Safety Document Objects in Optiva
SOP014225 在Optiva中创建和管理安全文档对象的PLM

SOP005534 PLM: Management Of Materials Shared with Non-PLM Sites
SOP005534 PLM：管理与非 PLM 站点共享的材料

SOP010755 PLM: Standard Change SOP: Parameter Update
SOP010755 PLM：标准变更 SOP：参数更新

SOP009271 PLM: Substance Change
SOP009271 PLM：物质变化

Appendices
附录

Appendix 1 – Project Deliverables Matrices
附录 1 – 项目可交付成果矩阵

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版本控制 record

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非常感谢您的阅读this
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如果您对本文档有任何意见或希望留下反馈，请发送电子邮件至： global.qualitycompliance@reckitt.com. For an overview of the Global QMS, refer to Reckitt Quality Manual (
有关全球质量管理体系的概述，请参阅利洁时质量手册（POL000103).

SOP009878 Appendix 1 - Project Deliverables Matrices
SOP009878 附录 1 - 项目可交付成果矩阵

Deliverables Matrices Summary
可交付成果矩阵摘要

This appendix describes the project deliverables and activities typically required at each phase of the Product Development process, for each element involved, refer to section 4.0 of this procedure, and the end-to-end process and stagegates for both operating models refer Global R&D Health Innovation Operating Model Procedure, SOP030749 and Global Health Base Business Operating Model Procedure, SOP030750
本附录描述了产品开发过程的每个阶段通常需要的项目可交付成果和活动，对于涉及的每个元素，请参阅 程序的第 4.0 节，两种操作模式的端到端流程和阶段门均参考全球研发健康创新运营模式程序，SOP030749以及全球健康基础业务运营模式程序，SOP030750.

Matrices have been developed for each of the key product classifications and product groups within Health. An overall matrix also describes the full list of project deliverables, which may be used as a reference guide for any product group or classifications not individually described here. The matrices include:
我们已经为健康部门的每个关键产品分类和产品组开发了矩阵。总体矩阵还描述了项目可交付成果的完整列表，这些清单可用作此处未单独描述的任何产品组或分类的参考指南。矩阵包括：

Overall Deliverables Matrix, refer to table 2.
总体D可分量基质，参照表2。

Licensed Medicines Deliverables Matrix, refer to table 3.
许可药品D可肝药基质，参见表3。

Medical Devices Deliverables Matrix, refer to table 4.
医疗器械 D可加工物矩阵，参见 table 4。

FDA OTC Monographs Deliverables Matrix, refer to table 5.
FDA OTC专著D可处理物基质，参见表5。

Vitamins, Minerals, & Supplements (VMS) Deliverables Matrix, refer to table 6.
维生素、矿物质和补充剂 （VMS） D可含物基质，请参阅表 6。

Cosmetics Deliverables Matrix, refer to table 7.
化妆品D可分割物基质，参见表7。

Biocides Deliverables Matrix, refer to table 8.
杀菌剂D可降解物基质，参见表8。

General Products Deliverables Matrix, refer to table 9.
一般产品D可分量基质，参照表9。

Note: Refer to section 8.0 of the procedure for Abbreviations of terms used in the matrices.
注意：请参阅过程的第 8.0 节，了解矩阵中使用的术语的缩写。

Table 1: Overall Deliverables Matrix
表 1：总体可交付成果矩阵

Table 2: Licensed Medicines Deliverables Matrix
表2：许可药品可交付成果矩阵