化妆品生产质量管理规范240问
化妆品生产质量管理规范240问
1.本书主要包括总则、机构与人员、质量保证与控制、生产设施与设备管理、物料与产品、生产过程管理、委托生产管理、产品销售管理八章。
2.作者深度参于了国家药品、医疗器械、特殊食品、化妆品认证或检查相关法规、标准、技术规范等文件的制修订。
1.本书主要包括总则、机构与人员、质量保证与控制、生产设施与设备管理、物料与产品、生产过程管理、委托生产管理、产品销售管理八章。
2.作者深度参于了国家药品、医疗器械、特殊食品、化妆品认证或检查相关法规、标准、技术规范等文件的制修订。
由于《规范》在我国属首次发布实施，无论化妆品注册人、备案人和受托生产企业人员，还是化妆品监督、检查人员在学习和贯彻其要求的过程中，大多会有一些疑问与困惑。为此，作者收集了其中高频率的或较有代表性的240个问题并组织有实践经验的化妆品检查员进行了解答。全书按照《化妆品生产质量管理规范》，结合《化妆品生产质量管理规范检查要点及判定原则》分为总则、机构与人员、质量保证与控制、生产设施与设备管理、物料与产品、生产过程管理、委托生产管理、产品销售管理八章，选取240个有代表性的问题进行了解答。
1988年北京大学医学部研究生毕业，曾从事近十年的药品研发工作。1999年加入国家药监局食品药品审核查验中心，先后从事药品、医疗器械、特殊食品、化妆品检查工作，任相关处室副处长或处长，学术委员会副主任委员。深度参于了国家药品、医疗器械、特殊食品、化妆品认证或检查相关法规、标准、技术规范等文件的制修订。积极开展国内外监管法规、检查理论和技术的研究，主持国家药监局研究课题15项。
1. 为什么说《规范》是对化妆品企业的法定要求？ / 001
2. 为什么要实施《规范》？ / 002
3. 《规范》的实施主体有哪些？是否包括境外企业？ / 003
4. 《规范》与企业质量管理体系是何关系？ / 003
5. 企业实施《规范》的前提是什么？ / 004
6. 《规范》具有哪些特点？ / 004
7. 质量管理体系主要包括哪些环节？ / 005
8. 《规范》实施的意义是什么？ / 006
第二章 机构与人员 / 007
9. 对质量管理体系中的组织机构的建立有什么具体要求？ / 007
10. 什么是组织机构图？组织机构图一般包括哪些部门？ / 007
11. 企业组织机构图中是否需要明确各部门、各岗位的具体人员？ / 008
12. 化妆品生产企业哪些岗位需要任命书？任命书包括哪些内容？ / 008
国务院2020 年6 月29 日发布的《化妆品监督管理条例》（以下简称《条例》）第二十九条规定：“化妆品注册人、备案人、受托生产企业应当按照国务院药品监督管理部门制定的化妆品生产质量管理规范的要求组织生产化妆品，建立化妆品生产质量管理体系，建立并执行供应商遴选、原料验收、生产过程及质量控制、设备管理、产品检验及留样等管理制度。”同时，《条例》第六十条还明确了“未按照化妆品生产质量管理规范的要求组织生产”的法律责任。所以实施《化妆品生产质量管理规范》（以下简称《规范》）是对我国化妆品企业的法规强制要求。为了落实《条例》规定，国家药品监督管理局组织制定了《规范》，于2022 年1 月7 日发布，自2022 年7 月1 日起正式施行。同年10 月25 日发布了《化妆品生产质量管理规范检查要点及判定原则》（以下简称《检查要点》），于12 月1 日起施行。
Shipping Overview:
• Shipping: Standard Domestic Shipping within the United States charges USD 4.99. Standard International Shipping from United Kingdom, Germany and Japan to the United States charges 14.99.
• Order Processing: Please allow 1-2 business days for order processing and preparation before shipment.
• Domestic Shipping: Orders within the U.S. are shipped via USPS or FedEx, depending on the origin of the product. The average transit time is 3-7 business days.
• International Shipping: Currently, we only ship within the USA.
• Tracking Information: Every order is trackable. You will receive a tracking number once your order has been shipped. Products may be shipped from various global fulfillment centers.
Shipping Delays:
Please note that shipping times may vary due to factors beyond our control, such as weather conditions, natural disasters, or peak holiday periods. While we strive to ensure timely delivery, the exact arrival time cannot be guaranteed and is managed by the shipping carrier.
Shipping Options:
-
Standard Delivery: Most orders are shipped within 3-7 business days. Larger items may utilize LTL shipping for safe handling.
-
Handling Time: We handle shipments on business days (Monday - Friday), with a preparation time of 1-2 days.
-
Additional Charges: Some items require additional shipping charges due to their size, weight, or special handling. These charges are specified on the product pages and are not eligible for shipping discounts.
-
Exclusions: Gift cards, packaging, taxes, and prior purchases do not count toward the minimum purchase requirement for free shipping. This offer is valid only for shipments to U.S. addresses, including Puerto Rico.
Delivery Details:
-
Estimates: Standard shipping within the US typically takes 3-7 business days. These are estimates and not guarantees.
-
Shipping Restrictions: We ship to all 50 states, Washington, DC, U.S. territories, and APO/FPO/DPO addresses. Shipping options vary based on the delivery address.
-
Remote Areas: Shipments to remote areas may incur additional charges or require pickup from a nearby shipping partner’s location.
Shipping Confirmation:
You will receive a shipping confirmation email with a tracking number as soon as your order is dispatched. If you do not receive this email immediately, please be assured that your items will arrive within the estimated delivery window provided at checkout.
Order Modifications:
If you need to cancel or modify your order, please contact our customer support immediately.
Issues with Delivery:
If your order shows as delivered but you have not received it, please contact the shipping carrier directly to resolve the issue. For persistent problems, contact our customer service at cs@everymarket.com.
Customer Support:
Our team is available 24/7 to assist you with any questions or concerns regarding your order. We are committed to ensuring a smooth shopping experience.
Return & Refund Policy Overview
Please review our return and refund policies below to ensure a smooth transaction process.
Return Policy
-
Duration: You have 30 days from receiving your item to initiate a return.
-
Condition: Items must be unworn, unwashed, with original tags and packaging intact.
-
Shipping Costs: Customers are responsible for return shipping costs.
-
Packaging: Ensure returned items are well-packaged to avoid damage during transit.
-
Tracking: Use a trackable and insured shipping method as we are not liable for items lost or damaged on return.
-
Initiating a Return: Contact us at cs@everymarket.com to start your return. We will provide a return shipping label and instructions upon approval. Returns without prior approval will not be accepted.
How to Return
-
Method: Returns must be sent back by mail to the address provided in the return instructions.
Return Label
-
Defective Products: Return labels are provided for defective items.
-
Non-Defective Returns: Customers are responsible for obtaining their return shipping label.
Product Conditions for Return
-
Eligible Products: Returns are only accepted for items in new condition.
Nonreturnable Items
Certain items are not eligible for return:
-
Electronic devices after 30 days (e.g., computers, laptops, Kindles)
-
Gift cards, prepaid game cards
-
Perishable goods, live insects, some jewelry, some health and personal care items
-
Customized or personalized products
-
Items with special shipping restrictions
Refund Policy
-
Window: Eligible products may be returned within 30 days of delivery for a refund.
-
Refund Method: Refunds are processed to the original payment method or as store credit for items purchased with gift cards.
-
Processing Time: Refunds are processed within 3-5 business days after we receive the return; please allow additional time for shipping and bank processing.
Claims
Inspect your order upon arrival and report any defects, damages, or incorrect items immediately to allow us to address the issue. For claims, contact our support team with details of the issue.
Exchange Policy
For the quickest service, return your original item and place a new order for the desired product once your return is accepted.
Return Address
EveryMarket Customer Service 2101 E Terra Ln, O'Fallon, MO 63366
Customer Support
Available 24/7 for any questions or assistance needed:
-
Phone: +1 636-312-5925
-
Email: cs@everymarket.com
1.本书主要包括总则、机构与人员、质量保证与控制、生产设施与设备管理、物料与产品、生产过程管理、委托生产管理、产品销售管理八章。
2.作者深度参于了国家药品、医疗器械、特殊食品、化妆品认证或检查相关法规、标准、技术规范等文件的制修订。
由于《规范》在我国属首次发布实施，无论化妆品注册人、备案人和受托生产企业人员，还是化妆品监督、检查人员在学习和贯彻其要求的过程中，大多会有一些疑问与困惑。为此，作者收集了其中高频率的或较有代表性的240个问题并组织有实践经验的化妆品检查员进行了解答。全书按照《化妆品生产质量管理规范》，结合《化妆品生产质量管理规范检查要点及判定原则》分为总则、机构与人员、质量保证与控制、生产设施与设备管理、物料与产品、生产过程管理、委托生产管理、产品销售管理八章，选取240个有代表性的问题进行了解答。
1988年北京大学医学部研究生毕业，曾从事近十年的药品研发工作。1999年加入国家药监局食品药品审核查验中心，先后从事药品、医疗器械、特殊食品、化妆品检查工作，任相关处室副处长或处长，学术委员会副主任委员。深度参于了国家药品、医疗器械、特殊食品、化妆品认证或检查相关法规、标准、技术规范等文件的制修订。积极开展国内外监管法规、检查理论和技术的研究，主持国家药监局研究课题15项。
1. 为什么说《规范》是对化妆品企业的法定要求？ / 001
2. 为什么要实施《规范》？ / 002
3. 《规范》的实施主体有哪些？是否包括境外企业？ / 003
4. 《规范》与企业质量管理体系是何关系？ / 003
5. 企业实施《规范》的前提是什么？ / 004
6. 《规范》具有哪些特点？ / 004
7. 质量管理体系主要包括哪些环节？ / 005
8. 《规范》实施的意义是什么？ / 006
第二章 机构与人员 / 007
9. 对质量管理体系中的组织机构的建立有什么具体要求？ / 007
10. 什么是组织机构图？组织机构图一般包括哪些部门？ / 007
11. 企业组织机构图中是否需要明确各部门、各岗位的具体人员？ / 008
12. 化妆品生产企业哪些岗位需要任命书？任命书包括哪些内容？ / 008
国务院2020 年6 月29 日发布的《化妆品监督管理条例》（以下简称《条例》）第二十九条规定：“化妆品注册人、备案人、受托生产企业应当按照国务院药品监督管理部门制定的化妆品生产质量管理规范的要求组织生产化妆品，建立化妆品生产质量管理体系，建立并执行供应商遴选、原料验收、生产过程及质量控制、设备管理、产品检验及留样等管理制度。”同时，《条例》第六十条还明确了“未按照化妆品生产质量管理规范的要求组织生产”的法律责任。所以实施《化妆品生产质量管理规范》（以下简称《规范》）是对我国化妆品企业的法规强制要求。为了落实《条例》规定，国家药品监督管理局组织制定了《规范》，于2022 年1 月7 日发布，自2022 年7 月1 日起正式施行。同年10 月25 日发布了《化妆品生产质量管理规范检查要点及判定原则》（以下简称《检查要点》），于12 月1 日起施行。
Shipping Overview:
• Shipping: Standard Domestic Shipping within the United States charges USD 4.99. Standard International Shipping from United Kingdom, Germany and Japan to the United States charges 14.99.
• Order Processing: Please allow 1-2 business days for order processing and preparation before shipment.
• Domestic Shipping: Orders within the U.S. are shipped via USPS or FedEx, depending on the origin of the product. The average transit time is 3-7 business days.
• International Shipping: Currently, we only ship within the USA.
• Tracking Information: Every order is trackable. You will receive a tracking number once your order has been shipped. Products may be shipped from various global fulfillment centers.
Shipping Delays:
Please note that shipping times may vary due to factors beyond our control, such as weather conditions, natural disasters, or peak holiday periods. While we strive to ensure timely delivery, the exact arrival time cannot be guaranteed and is managed by the shipping carrier.
Shipping Options:
-
Standard Delivery: Most orders are shipped within 3-7 business days. Larger items may utilize LTL shipping for safe handling.
-
Handling Time: We handle shipments on business days (Monday - Friday), with a preparation time of 1-2 days.
-
Additional Charges: Some items require additional shipping charges due to their size, weight, or special handling. These charges are specified on the product pages and are not eligible for shipping discounts.
-
Exclusions: Gift cards, packaging, taxes, and prior purchases do not count toward the minimum purchase requirement for free shipping. This offer is valid only for shipments to U.S. addresses, including Puerto Rico.
Delivery Details:
-
Estimates: Standard shipping within the US typically takes 3-7 business days. These are estimates and not guarantees.
-
Shipping Restrictions: We ship to all 50 states, Washington, DC, U.S. territories, and APO/FPO/DPO addresses. Shipping options vary based on the delivery address.
-
Remote Areas: Shipments to remote areas may incur additional charges or require pickup from a nearby shipping partner’s location.
Shipping Confirmation:
You will receive a shipping confirmation email with a tracking number as soon as your order is dispatched. If you do not receive this email immediately, please be assured that your items will arrive within the estimated delivery window provided at checkout.
Order Modifications:
If you need to cancel or modify your order, please contact our customer support immediately.
Issues with Delivery:
If your order shows as delivered but you have not received it, please contact the shipping carrier directly to resolve the issue. For persistent problems, contact our customer service at cs@everymarket.com.
Customer Support:
Our team is available 24/7 to assist you with any questions or concerns regarding your order. We are committed to ensuring a smooth shopping experience.
Return & Refund Policy Overview
Please review our return and refund policies below to ensure a smooth transaction process.
Return Policy
-
Duration: You have 30 days from receiving your item to initiate a return.
-
Condition: Items must be unworn, unwashed, with original tags and packaging intact.
-
Shipping Costs: Customers are responsible for return shipping costs.
-
Packaging: Ensure returned items are well-packaged to avoid damage during transit.
-
Tracking: Use a trackable and insured shipping method as we are not liable for items lost or damaged on return.
-
Initiating a Return: Contact us at cs@everymarket.com to start your return. We will provide a return shipping label and instructions upon approval. Returns without prior approval will not be accepted.
How to Return
-
Method: Returns must be sent back by mail to the address provided in the return instructions.
Return Label
-
Defective Products: Return labels are provided for defective items.
-
Non-Defective Returns: Customers are responsible for obtaining their return shipping label.
Product Conditions for Return
-
Eligible Products: Returns are only accepted for items in new condition.
Nonreturnable Items
Certain items are not eligible for return:
-
Electronic devices after 30 days (e.g., computers, laptops, Kindles)
-
Gift cards, prepaid game cards
-
Perishable goods, live insects, some jewelry, some health and personal care items
-
Customized or personalized products
-
Items with special shipping restrictions
Refund Policy
-
Window: Eligible products may be returned within 30 days of delivery for a refund.
-
Refund Method: Refunds are processed to the original payment method or as store credit for items purchased with gift cards.
-
Processing Time: Refunds are processed within 3-5 business days after we receive the return; please allow additional time for shipping and bank processing.
Claims
Inspect your order upon arrival and report any defects, damages, or incorrect items immediately to allow us to address the issue. For claims, contact our support team with details of the issue.
Exchange Policy
For the quickest service, return your original item and place a new order for the desired product once your return is accepted.
Return Address
EveryMarket Customer Service 2101 E Terra Ln, O'Fallon, MO 63366
Customer Support
Available 24/7 for any questions or assistance needed:
-
Phone: +1 636-312-5925
-
Email: cs@everymarket.com
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