当天发货正版 无菌药品/药品GMP指南 国家食品药品监督管理局药品认证管理中心组 中国医药科技出版社 9787506750769中图文轩
当天发货正版 无菌药品/药品GMP指南 国家食品药品监督管理局药品认证管理中心组 中国医药科技出版社 9787506750769中图文轩
《药品GMP指南》由“质量管理体系、质量控制实验室与物料系统、厂房设施与设备、无菌药品、口服固体制剂、原料药”六个分册组成。基本涵盖了新修订药品GMP的主要内容，每部分指南从背景介绍、法规要求、技术要求、实施指导、实例分析及要点备忘等方面展开。如在公共系统指南中，对药品生产与质量控制的通用部分内容进行了重点说明，以帮助理解新修订药品GMP中质量风险管理、纠正与预防措施(CAPA)、变更、偏差等新概念。在具体剂型指南中，根据不同剂型的生产工艺、关键质量控制点的不同进行了具体分析。公共系统指南与具体剂型指南各自独立又相互补充，使药品GMP系统性要求与产品风险控制**结合，为药品GMP的有效实施打下基础。本书为《无菌药品》，由张...
《药品GMP指南》由“质量管理体系、质量控制实验室与物料系统、厂房设施与设备、无菌药品、口服固体制剂、原料药”六个分册组成。基本涵盖了新修订药品GMP的主要内容，每部分指南从背景介绍、法规要求、技术要求、实施指导、实例分析及要点备忘等方面展开。如在公共系统指南中，对药品生产与质量控制的通用部分内容进行了重点说明，以帮助理解新修订药品GMP中质量风险管理、纠正与预防措施(CAPA)、变更、偏差等新概念。在具体剂型指南中，根据不同剂型的生产工艺、关键质量控制点的不同进行了具体分析。公共系统指南与具体剂型指南各自独立又相互补充，使药品GMP系统性要求与产品风险控制**结合，为药品GMP的有效实施打下基础。本书为《无菌药品》，由张爱萍等编著。
张爱萍等编著的《无菌药品》是《药品GMP指南》丛书之一，为新修订的《药品生产质量管理规范》的实施提供全面、深入、实用的科学参考。
《无菌药品》由国家食品药品监督管理局药品认证管理中心编写，紧扣新修订的《药品生产质量管理规范》，并参考美国、日本、欧盟、世界卫生组织等的相关文件。介绍无菌药品的GMP相关知识，包括背景介绍、法规要求、技术要求、实施指导、实例分析、要点备忘等板块，具体内容包括质量风险管理、生产管理、人员、清洗和准备、药液的配制、灌装、冻干、轧盖、灭菌方法、药品的最终处理、无菌工艺模拟试验、清洁和消毒、环境监控、无菌检查、吹灌封技术、隔离技术及实施案例等。
《无菌药品》内容丰富，实用性强，为药品生产企业做好《药品生产质量管理规范》的实施工作提供有力的帮助。可供药品生产企业及工程设计、设备制造、药品监管等单位的管理、技术、生产和检查人员参考使用。
基本信息
书名:无菌药品/药品GMP指南
定价：256.00元
作者:国家食品药品监督管理局药品认证管理中心组
出版社：中国医药科技出版社
出版日期：2011-08-01
ISBN：9787506750769
字数：
页码：
版次：1
装帧：平装
开本：大16开
商品重量：0.863kg
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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.
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Return Policy
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Duration: You have 30 days from receiving your item to initiate a return.
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Condition: Items must be unworn, unwashed, with original tags and packaging intact.
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Shipping Costs: Customers are responsible for return shipping costs.
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Packaging: Ensure returned items are well-packaged to avoid damage during transit.
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Tracking: Use a trackable and insured shipping method as we are not liable for items lost or damaged on return.
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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.
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Method: Returns must be sent back by mail to the address provided in the return instructions.
Return Label
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Defective Products: Return labels are provided for defective items.
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Non-Defective Returns: Customers are responsible for obtaining their return shipping label.
Product Conditions for Return
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Eligible Products: Returns are only accepted for items in new condition.
Nonreturnable Items
Certain items are not eligible for return:
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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
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Window: Eligible products may be returned within 30 days of delivery for a refund.
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Refund Method: Refunds are processed to the original payment method or as store credit for items purchased with gift cards.
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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
《药品GMP指南》由“质量管理体系、质量控制实验室与物料系统、厂房设施与设备、无菌药品、口服固体制剂、原料药”六个分册组成。基本涵盖了新修订药品GMP的主要内容，每部分指南从背景介绍、法规要求、技术要求、实施指导、实例分析及要点备忘等方面展开。如在公共系统指南中，对药品生产与质量控制的通用部分内容进行了重点说明，以帮助理解新修订药品GMP中质量风险管理、纠正与预防措施(CAPA)、变更、偏差等新概念。在具体剂型指南中，根据不同剂型的生产工艺、关键质量控制点的不同进行了具体分析。公共系统指南与具体剂型指南各自独立又相互补充，使药品GMP系统性要求与产品风险控制**结合，为药品GMP的有效实施打下基础。本书为《无菌药品》，由张爱萍等编著。
张爱萍等编著的《无菌药品》是《药品GMP指南》丛书之一，为新修订的《药品生产质量管理规范》的实施提供全面、深入、实用的科学参考。
《无菌药品》由国家食品药品监督管理局药品认证管理中心编写，紧扣新修订的《药品生产质量管理规范》，并参考美国、日本、欧盟、世界卫生组织等的相关文件。介绍无菌药品的GMP相关知识，包括背景介绍、法规要求、技术要求、实施指导、实例分析、要点备忘等板块，具体内容包括质量风险管理、生产管理、人员、清洗和准备、药液的配制、灌装、冻干、轧盖、灭菌方法、药品的最终处理、无菌工艺模拟试验、清洁和消毒、环境监控、无菌检查、吹灌封技术、隔离技术及实施案例等。
《无菌药品》内容丰富，实用性强，为药品生产企业做好《药品生产质量管理规范》的实施工作提供有力的帮助。可供药品生产企业及工程设计、设备制造、药品监管等单位的管理、技术、生产和检查人员参考使用。
基本信息
书名:无菌药品/药品GMP指南
定价：256.00元
作者:国家食品药品监督管理局药品认证管理中心组
出版社：中国医药科技出版社
出版日期：2011-08-01
ISBN：9787506750769
字数：
页码：
版次：1
装帧：平装
开本：大16开
商品重量：0.863kg
Shipping Overview:
• Shipping: Standard Domestic Shipping within the United States charges USD 4.99. Standard International Shipping from United Kingdom and Germany 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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