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注册协议

在以下条款中，"用户"是指向天美（中国）网站申请注册成为会员的个人或者单位。

用户同意此在线注册条款之效力如同用户亲自签字、盖章的书面条款一样，对用户具有法律约束力。只有用户完全同意所有服务条款并完成注册程序，才能成为天美（中国）网站的正式会员用户。本注册条款自用户注册成功之日起在用户与天美（中国）之间产生法律效力。

第一条提供个人信息

1-1 用户承诺并保证自己是具有完全民事行为能力和完全民事权利能力的自然人、法人、实体和组织。用户在此保证所填写的用户信息是真实、准确、完整、及时的，并且没有任何引人误解或者虚假的陈述，且保证天美（中国）可以通过用户所填写的联系方式与用户取得联系。

1-2用户承诺将及时更新其用户信息以维持信息的有效性。

1-3如果用户提供的资料或信息包含有不正确、不真实的信息，天美（中国）保留取消用户会员资格并随时结束为该用户提供服务的权利。

第二条邮件通知

用户充分理解，天美（中国）将通过电子邮件的方式与注册会员保持联络及沟通，用户在此同意天美（中国）通过电子邮件方式向其发送包括会员信息、天美（中国）产品及服务信息在内的相关商业及非商业联络信息。

第三条会员身份确认

3-1 用户注册成功后将得到一个用户名和密码，用户凭用户名和密码享受天美（中国）向其会员用户提供的产品和服务。

3-2 用户将对用户名和密码安全负全部责任，并且用户对以其用户名进行的所有活动和事件负全责。用户可以随时修改密码。

3-3 用户若发现任何非法使用用户帐号或存在安全漏洞的情况，请立即通告天美（中国）。

第四条服务条款的修改和服务体系修订

天美（中国）有权在必要时修改服务条款，天美（中国）服务条款一旦发生变动，将会在重要页面上提示修改内容。如果不同意所改动的内容，用户可以主动取消获得的网络服务。如果用户继续使用天美（中国）网络服务，则视为接受服务条款的变动。

第五条用户的权利和义务

5-1 用户有权利使用自己的用户名和密码随时登录天美（中国）网站访问需要的资源。

5-2用户保证不会利用技术或其他手段破坏及扰乱天美（中国）网站。

5-3用户应尊重天美（中国）网站及其他第三方的知识产权的合法权利，并保证在发生上述事件时尽力保护天美（中国）及其合作伙伴等免于因该等事件受到影响或损失；天美（中国）保留用户侵犯天美（中国）网站知识产权时终止向该用户提供服务的权利。

第六条天美（中国）的权利和义务

6-1天美（中国）承诺对用户资料采取对外保密措施，不向第三方披露用户资料，不授权第三方使用用户资料，除非：

6-1-1依据法律法规的规定应当提供；

6-1-2行政、司法等有权部门要求天美（中国）提供；

6-1-3用户同意天美（中国）向第三方提供；

6-1-4天美各分子公司和代理商需要使用用户个人信息。

6-2 天美（中国）有权利对用户进行审查并决定是否接受用户成为天美（中国）会员。

6-3 天美（中国）保留在用户违反国家、地方法律法规规定或违反本在线注册条款的情况下终止为用户提供服务并终止用户帐号的权利，并且在任何情况下，天美（中国）对任何间接、偶然、特殊及继起的损害不负责任。

第七条服务的终止

7-1 用户有权随时申请终止其会员资格。

7-2用户违反国家、地方法律法规规定或违反本在线注册条款的情况下，天美（中国）提前通知用户后可以提前终止服务。

第八条争议解决及法律适用

8-1 因本服务条款有关的一切争议，双方当事人应通过友好协商方式解决。如果协商未成，双方同意向天美（中国）主要经营地的人民法院起诉。

8-2 本注册条款的效力、解释、履行和争议的解决均适用中华人民共和国法律法规和计算机、互联网行业的规范。

第九条不可抗力

9-1 因不可抗力或者其他意外事件，使得本条款履行不可能、不必要或者无意义的，遭受不可抗力、意外事件的一方不承担责任。

9-2 不可抗力、意外事件是指不能预见、不能克服并不能避免且对一方或双方当事人造成重大影响的客观事件，包括但不限于自然灾害如洪水、地震、瘟疫流行和风暴等以及社会事件如战争、动乱、政府行为等。

9-3 用户同意鉴于互联网的特殊性，黑客攻击、互联网连通中断或者系统故障等属于不可抗力，由此给用户或者第三方造成的损失不应由天美（中国）承担。

用户在此再次保证已经完全阅读并理解了上述会员注册条款并自愿正式进入天美（中国）会员在线注册程序。

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FAQ in GMP regarding Vaccine Production

FAQ in GMP regarding Vaccine Production

What is GMP?

GMP, the abbreviation of Good Manufacturing Practices, are the practices required in order to conform to the guidelines that control the authorization and licensing of the manufacturers of pharmaceuticals and food and etc. GMP request these manufacturers to implement policy, process control, quality assurance and testing to assure the products are consistently high quality and meeting regulation.

Who established the GMP?

The first WHO draft text on good manufacturing practices (GMP) was prepared in 1967 by a group of consultants at the request of the Twentieth World Health Assembly (resolution WHA20.34). It was subsequently submitted to the Twenty-first World Health Assembly under the title Draft requirements for good manufacturing practice in the manufacture and quality control of medicines and pharmaceutical specialties and was accepted.

What is the correct concept to implement GMP?

Making poor quality products does not save money. In the long run, it is more expensive finding mistakes after they have been made than preventing them in the first place. GMP is designed to ensure that mistakes do not occur. Implementation of GMP is an investment in good quality medicines. This will improve the health of the individual patient and the community, as well as benefiting the pharmaceutical industry and health professionals. Making and distributing poor quality medicines leads to loss of credibility for everyone: both public and private health care and the manufacturer.

What is the current version of the GMP?

The current document is a revision of WHO Good manufacturing practices for pharmaceutical products: main principles, previously published in WHO Technical Report Series, No. 961, 2011, Annex 3.

What are the main requirements of the current version of GMP?

The current version GMP emphasize on:

1. Data authenticity, integrity, batch record traceability, backup and audit trail functions

2. Print function: printable records per batch

3. Data storage: To have data upload storage function and the exported data cannot be changed.

4. Authorization: With permission settings, especially where parameters can be set and only QA personnel can make any changes.

5. Prevent contamination nor cross-contamination

6. Avoid human mistakes nor errors

7. Raw materials, processes, plant facilities, process equipment, etc. have document support and fixed procedures, such as IQ/OQ/PQ for process equipment.

Which part of the process equipment is used in vaccine production?

High speed and ultra-speed centrifuges have been widely used for separating and purifying samples in the production process of vaccine production, such as influenza vaccine, rabies vaccine, polio vaccine, meningitis, Hib pneumonia, whooping cough, epidemic encephalitis, hepatitis B and other vaccines. The himac series of centrifuges from Koki Holdings (formerly Hitachi Koki Hitachi Machinery Co., Ltd.) have been manufacturing for more than 60 years since 1955. Its ultra-speed and high-speed centrifuges have been used by many world famous vaccine companies for sample collection, treatment, removal of impurities, concentration of the virus sample, and final purification.

How does the himac centrifuge help users to meet GMP requirements in data management?

The himac centrifuges come with password access function with three access levels. Its Log Manager software provides real-time data management that can record intervals range from 10 seconds to 5 minutes. The software complies with U.S. FDA 21 CFR Part 11, with electronic signature, audit trail, data file encryption and other functions that can ensure that all data in the whole process is true, complete, traceable and in line with GMP requirements. The himac ultracentrifuge also has built-in USB and LAN port for data communication. In addition, the network version of Log Manager Software allows managing up to 16 himac ultra and high speed centrifuges and performing real-time data management and realizing remote data management.

What protection does the himac centrifuge offer in terms of sterilization and contamination prevention?

The current version of GMP put emphasis on contamination prevention. Biosafety is the primary consideration for all vaccine production. The himac centrifuge can be equipped with HEPA. Some of the rotors can be autoclaved. There are also bio-safe rotors or bio-sealed rotors, which provide bio-safety and ensure the quality of the vaccine.

If the centrifuge is used for large-scale production, can SIP (Sterilization In Place) be done?

For large-scale production needs, users can choose Himac's large-capacity continuous flow ultracentrifuge CC40NX for a large number of sample purification. The CC40NX meets the requirements of GMP. In addition to the conventional CIP, CC40NX has the unique SIP (Sterilization In Place) function for disinfection and sterilization which can enhance the efficiency of sterilization and thus the quality of vaccine is guaranteed.

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