ISO 22716 Complete Package [Downolad]

 获得你的认证 以尽可能低的成本

GMP-Comp

ISO 22716 GMP完整包

实现ISO 22716 GMP认证所需的一切
1小时现场1对1在线课程
12个月的电子邮件支持服务

限时优惠

价格。 389 $

节省时间

为什么要从一个空白页开始。今天就开始你的项目,并节省高达80%的时间和金钱。

省钱

具有成本效益的实施。比现场顾问便宜得多,比从头开始做需要的时间少得多

3-图像

在线咨询

这个套餐包括在线咨询、文件审查、持续12个月的电子邮件支持和定期更新服务。

这个ISO软件包是一个完整的ISO 22716 2007(当前版本)文件包,包含了所有的内容,包括程序、模型、流程、表格、检查表、工具、详细的指南和说明,需要。

? Launch your ISO 22716 – GMP project.
? Create your ISO 22716 – GMP documentation.
? Quickly obtain ISO 22716 – GMP certification.
? Benefit from 12 Month Email Support Service.

每一个 文件,每 步骤,一切都在一个 数天!

The ISO 22716 – GMP kit is also newbie-friendly and composed in a way that even allows beginners to set up an efficient ISO 22716 2007 management system from scratch without hassles.
这个软件包消除了所有的压力,使一切变得如此简单,你可以在不到几天的时间内创造出本来需要几个月的东西。

ISO 22716 GMP

Template SOPs & Forms List
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组织的背景

? A. ISO 22716 Cosmetic GMP Manual
? B. Sample Job Descriptions
? C. Work Instructions Samples for Equipment
? D. Standard Operating Procedures (SOP?s) and Associated Forms

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记录的控制

? SOP Control of Records
? Master List of Controlled Records
? Master List of Computers
? E-Data Backup

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Personnel Hygiene & Health

? Sop Personnel Hygiene & Health
? Hygiene Monitoring Checklist
? Protocol Verification Checklist
? Personal Hygiene Checklist
? Worker Health Card
? Staff Sickness record

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虫害管理

? SOP Pest Management
? Daily Rodent Control Monitoring Sheet
? Weekly Bait Stations Monitoring and Service Sheet
? Insect Control Sheet
? Backyard Control Sheet
? Water Tank Cleaning Sheet

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对采购的控制

? SOP Purchasing
? Supplier Questionnaire Form
? Supplier Assessment Form
? Approved Suppliers List
? Purchase Requisition
? Purchase Order
? Supplier Monitoring Report
? RFQ

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生产

? SOP Production
? Job Sheet
? Job Control Sheet
? Monthly Production Schedule
? Product Ingredient Form

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成品

? SOP for Finished Product
? Acceptance Criteria
? Release Form
? Product Delivery Note
? Commercial Invoice
? Disposition Form
? Invoice

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管理回顾

? SOP for Management Review Meeting
? Nomination Letter for MR
? Minutes of Meeting

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管理回顾

? SOP for Management Review Meeting
? Nomination Letter for MR
? Minutes of Meeting

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交叉污染

? SOP for preventing Cross contamination
? Visitor Health Verification Checklist
? Visitor Register

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质量控制实验室

? SOP for Quality Control Lab
? Material Acceptance Criteria
? Test Result Review
? OUT OF SPECIFICATION (OOS) REPORT
? OOS Log

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废物

? SOP for Wastes
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分包合同

? SOP for Subcontracting
? Contractor Questionnaire Form
? Contractor Assessment-Audit Form
? Contracting Requisition
? Contract Acceptor Capability Self-Assessment Form

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Complaints & Recalls

? SOP for Complaints & Recalls
? Complaint Reporting, Investigation & Follow Up Form
? Injury Reporting Form
? Recall Management Team List
? Shipping Log
? Problem Report Form for Recall
? Recall-Withdrawal Form
? Recall-Withdrawal Status Report
? ATTACHMENT A – 21 CFR part 7 subpart C
? ATTACHMENT B- Recall Public Warning Format

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批量发布

? SOP for Batch Release & Batch Record Review
? Batch Release Note
? Batch Records Review & Approval Log

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文件的控制

? SOP Control of Documents
? Master List of Controlled Documents
? Master List of External Origin Documents
? Document Distribution List
? Change and Disposition Form
? Document Disposition Log

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Personnel & Training

? SOP Personnel & Training
? Organizational Chart
? Training Attendance Form
? Training Evaluation Form
? Training Needs Assessment Form
? Training Program

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房产

? SOP Premises
? Sanitation Record
? Master Sanitation Schedule
? Approved Chemicals List
? Daily Checklist of Restrooms / Hand Wash Facility (Production Hall)
? Factory Layout Plan

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设备

? SOP Equipment
? List of Key Equipment
? Production Log
? Equipment cleaning schedule & Log
? Preventive Maintenance Schedule & Log
? Corrective Maintenance Log
? List of Gauges & Measuring Instruments
? Calibration Schedule & Log

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储存

? SOP Storage
? Material Discrepancy Report
? Goods receipt Note ? GRN
? Store Register
? Material requisition Sheet
? Nonconformance Report ? NCR
? Delivery Note
? Disposal Note

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颜色添加剂和化学成分

? SOP for Color Additives and ? Chemical Ingredients
? List of Color Additives and ? Chemical Ingredients
? Color Additives Permitted for Use in Cosmetics
? Color Additives Subject to Certification & permitted for use in Cosmetics
? Provisionally Certified Colors
? Requirements for Specific Cosmetic Products
? MSDS SHEETS

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防止掺杂使假

? SOP for preventing Adulteration
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无毒品政策

? SOP for Analysis of Data
? SOP for Drug Free Policy

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改进

? SOP for Improvement
? CPA Request Form
? CPA Log Sheet
? Suggestion Form
? Suggestion Log

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对不合规格产品的处理

? SOP for Treatment of Out of Specification Product
? Reprocessing Note
? Root-Cause-Analysis

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偏差

? 23 SOP for Deviations
? Deviation Form
? Deviation Log

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更改控制

? SOP for Change Control
? Change Request Form
? Change Evaluation, Approval & Review Form
? Change Log

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内部审计

? SOP for Internal Audit
? Audit Checklist
? Audit Findings & Recommendations Report
? Audit Follow Up Report
? Audit Log

所有必要文件的模板。
? The package is comprehensive and comes with all the templates you need to comply with ISO 22716 – fully acceptable by the certification audit.
文件是90%完整的,只需要进行简单的定制

我们已经完成了文件上要求的大约90%的信息。要完成它们,你必须只填写公司的名称、负责任的各方以及贵公司特有的任何其他信息。你将在整个过程中得到指导,对需要的和可选的要素进行评论。
我们在ISO 22716文件上下功夫,以便向其所有用户保证,他们已经准确和最有效地完成了一切。

组织清晰、逻辑性强的步骤
?  每份文件都是有顺序的,这样你就可以完美地遵循其顺序。按照每个步骤的顺序,确保没有任何遗漏,没有人在过程中迷失。包括的logograms帮助员工理解每个过程,使质量管理更容易,过程更容易遵循。
完全可编辑的文件
? Each document is available in MS Word or MS Excel. In this format, you can easily customize them as you deem fit for your business. This way, it?s also way easier to create and maintain your business brand by adding corporate logos and colors and then simply edit headers and footers to match your preferred style.

ISO 22716 - GMP套件为您提供

即时访问以下内容
– 1-hour free online consultation with ISO 22716 expert
– ISO 22716: 2007 Quality manual (40 detailed pages)
– 35 documented procedures

– 27 Reports and forms templates

– KPI Key Performance Indicator Tracking, Internal audit, non-conformities, and corrective action tracking
– Benefit from 12 Months Email Support Service
GMP-Comp

了解ISO 22716 - GMP认证。

在化妆品行业的重要性和好处

The cosmetics industry is a thriving business, but it’s not without scrutiny and setbacks. Proven hazardous materials such as lead have been banned, sustainable packaging is a question, water management is a challenge, and then there’s also the issue of inaccurate marketing strategies and animal testing.

因此,制造商、供应商和承包商必须确保其产品的生产和控制始终符合ISO 22716的质量水平要求。

在这篇文章中,QSE学院解释了化妆品公司如何面对这些挑战,并通过实施ISO 22716良好生产规范和获得认证继续满足其领域的要求。

ISO 22716简介

ISO 22716《良好生产规范》(GMP)。 化妆品指南的目的是为化妆品的生产、控制、储存、包装、标签、运输和分销提供指导。

ISO 22716的安排也是为了补充现有的管理系统,如ISO 9001。它强调了向客户提供的化妆品的质量,以及在产品生产和销售阶段的责任和可追溯性。

ISO 22716 GMP涵盖了化妆品供应链的所有方面。它侧重于产品的安全和质量,以及产品对消费者、制造商、零售商、供应商和品牌持有人的影响。

However, it doesn’t deal with safety aspects for the environment’s protection or the safety of personnel involved in the plant.

为什么ISO 22716认证与您的化妆品公司有关?

First, let us define the word ?cosmetics?. According to the European Union Cosmetics Directive, a cosmetic is any substance, mixture, or preparation intended to be placed in contact with:

? external parts of the human body, such as the hair system, lips, epidermis, nails, and external genital organs
? the teeth and the mucous membranes of the oral cavity.

请注意,这些产品是专门或主要用于清洁、香水、改变外观、纠正气味、保护或保持上述身体部位的良好状态。

进行彻底的检查以评估当前的制造和生产过程。

ISO 22716作为一个指南,指导企业如何致力于生产优质、优秀和安全的化妆品产品。

Keep in mind that your cosmetic company’s manufacturing system will be inspected and audited on the following areas in accordance with the ISO 22716 guide:

? Personnel or employees
? Contracting/subcontracting
? Material management
? Facilities, buildings, premises
? Laboratory quality controls
? Production and in-process controls
? Packaging and labeling
? Storage
? Distribution
? Documentation
? Complaint and recalls
? Internal audits

ISO22716认证对化妆品公司的好处

? Simple implementation and integration with other certification standards
?Cosmetic companies, regardless of the complexity and size, can implement ISO 22716. In addition, the ISO 22716 certification integrates well with BRC Consumer Products and ISO 9001.

? Control quality, good manufacturing, hazards, and risks

ISO 22716认证帮助公司达到良好生产规范的原则。它还帮助化妆品公司控制与其产品相关的危害和风险。因此,这确保了整个供应链的持续改进。

? Process management

ISO 22716从流程的开始到结束都有涉及。它包括原材料的制造商、生产商、分销商、分包商、进口商和出口商。

? Supply chain management

ISO 22716认证是全世界公认的,使化妆品公司能够处理化妆品供应链中的安全和质量合规问题。

? Legal and Regulatory compliance

你知道化妆品行业的专业人士撰写了ISO 22716吗?该认证支持公司努力保持当前和预期未来符合适用的法律、监管和法定要求。

? Risk management

ISO 22716认证的结构是协助化妆品公司在整个审计过程中确定、控制和处理风险。

欧盟《化妆品良好生产规范》的要求

?Cosmetic companies, regardless of the complexity and size, can implement ISO 22716. In addition, the ISO 22716 certification integrates well with BRC Consumer Products and ISO 9001.
欧盟化妆品GMP要求包括在《欧盟化妆品条例》中。该条例创建了一些要求,以确保客户和参与化妆品行业的人,无论是欧洲的还是非欧洲的,都是安全的。

法律要求规定,所有在欧盟流通的化妆品必须按照ISO 22716《良好生产规范》创建。它涵盖了制造、测试、标签、包装、分销和文件等基本流程。

化妆品公司可以通过ISO 22716认证或表明产品按照ISO 22716生产的声明来证明符合要求。

ISO 22716安排了以下具体要求和原则。

? Personnel

ISO 22716规定,工作人员应接受适当的培训,以制造、控制和储存符合质量标准的产品。

它包含了一些特征和参数,包括组织结构图、员工人数、管理层和员工的主要职责、培训和车间、员工的个人卫生和健康、访客和未经培训的人员。

? Equipment

Equipment should be relevant and useful for the intended purpose. All pieces of equipment must be cleaned, sanitized, and maintained. ISO 22716 requires a cosmetics company’s equipment to be designed, installed, calibrated, and have adequate back-up systems.

此外,设备的使用和访问应只提供给经授权的人员。

? Raw materials and packaging

ISO 22716规定,采购的材料,包括原材料和包装材料,应符合规定的验收标准,对最终产品的质量具有重要意义。它包括物理、微生物和化学方面。同样,生产中使用的水的质量也必须得到控制。

必须为原材料的采购、接收、状态、释放、储存和重新评估制定适当的标准和措施。化妆品公司还应该提供可获得的产品信息。

? Premises and Locations

场所的设计、建造、定位和使用应确保对产品的保护,以及有效的清洁、卫生和维护。这样做的目的是将原材料、包装单元和产品混淆的风险降到最低。

? Production

ISO 22716要求化妆品公司在制造过程和包装操作的每个阶段都要采取措施,以制造出符合确定特征的最终产品。

化妆品公司应该能够确保相关文件的可用性,进行启动检查,分配批号,并重新储存原材料。他们必须在制造和包装阶段确定过程中的操作、过程中的控制和产品储存。

? Subcontracting

分包是指获得符合规定的合同授予者要求的产品或服务。该协议的书面合同必须由承包商和分包商设定、确认和控制。

? Finished products

ISO 22716要求化妆品公司在向市场销售产品之前,必须确保最终产品符合规定的验收标准。同样地,成品必须按照设定的测试方法进行控制。

公司应以保持最终产品的质量的方式来处理储存、装运、召回和退货。

? Quality control laboratory

质量控制实验室应在人员、设备、场所、分包和文件方面应用ISO 22716规定的原则。

质量控制实验室必须执行采样、测试和分析,以确保相关和必要的控制。这提供了一种保障,即只有当材料的质量符合既定的验收标准时,才可以配发使用,成品才可以发放。

? Deviations

必须通过收集足够的数据来确定偏差,并采取纠正措施。化妆品公司要记住的另一件事是确定对不符合规格的产品的处理。

? Waste Management

ISO 22716要求化妆品公司以卫生、有序和及时的方式处理废物。

? Conducting and Controlling Changes

Authorized personnel should approve and conduct changes that could impact the finished product’s quality on the basis of adequate data.

? Handling complaints and recalls

ISO 22716 instructs that all complaints associated with the products need to be managed, investigated, reviewed, and followed-up on. Appropriate actions should be taken if there’s a recall, and corrective action must follow.

同时,双方应就承包经营情况下的投诉处理制度达成一致。

? Performing an internal audit

化妆品公司应监测ISO 22716良好生产规范的实施和状态。如有必要,应建议并计划采取纠正措施。

? Proper and complete documentation

ISO 22716规定,文件是良好生产规范的一个重要组成部分。文件的目的是确定GMP活动,确保过程的证据,并防止信息的混乱和丢失。

化妆品公司应该建立自己的系统来建立、设计、安装和维护文件,这必须仍然取决于产品的类型和组织结构。

ISO 22716 2007版 完整的套件

– Price: 389 $

符合2007年版本 的ISO 22716标准,最新版本

文件包括。: 80份执行ISO 22716 2007版本的文件

MS Office 2007, MS Office 2010, MS Office 2013

文件的语言是英语也有法文版本

文件是完全可编辑的 – just enter all information specific to your company.

– Acceptable for the ISO 22716 certification audit? 是的,ISO 22716要求的所有文件都包括在内。

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1571645526-17020501-245x245-90-Day-Guarantee

If for whatever reason during the first 90 days of your purchase, you are not satisfied for any reason, simply contact support@qse-academy.com and our support team will issue you an immediate and full refund.

纹路的力量

2007年ISO 22716的完整包装

版本

完整的套件

以执行ISO 22716 : 2007版本

限时优惠: 50 % OFF

价格:  389 $

而不是766 $

我们的客户怎么想。

?Getting ISO 22716 GMP template SOPs and forms list from QSE Academy has been one of the best decisions we?ve made.
Hence, we were able to finish all tasks within our expected timeframe. From developing a quality manual to updating control of documents, QSE Academy made sure their consultants were always assisting”

吉米-唐斯
Quality Manager?
?Our business wanted to create an ISO 22716 quality manual, but we were on a tight budget. Fortunately, QSE Academy offered half the amount other firms were expecting us to pay. Not only did we avoid hefty expenses, but we also saved time and effort in complying with the standard.?
卢克-麦克唐纳
质量经理
?Our business wanted to create an ISO 22716 quality manual, but we were on a tight budget. Fortunately, QSE Academy offered half the amount other firms were expecting us to pay. Not only did we avoid hefty expenses, but we also saved time and effort in complying with the standard.?
卡森-李维斯
质量经理

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