GDP/ GMP/ CQA审核和培训

GDP/ GMP/ CQA审核和培训

gcp sertifikat

 

NBS科学有限公司 通过教育和协助，帮助公司减少将产品投放市场所需的时间 质量保证 实施人员 美国食品药品监督管理局/欧洲、中东和非洲地区 合规的质量体系.

我们专注于协助制药, 生物技术, 生物制剂, 医疗装置, 及其附属产业 审计 相对于良好临床实践, GCP, Good Distribution Practices, 国内生产总值, 良好实验室规范,良好实验室规范, 和良好生产规范, 良好生产规范.

欲了解详情，请通过电子邮件联系我们: head_office@nbscience.com

1) CQA ( Certified Quality Auditor ) certification

细节 – CQA审核员认证

2) GDP audit

How will it Work?

Supplier Initiated Process

•Excipient supplier selects NBScience GDP Auditor

•Supplier identifies if GDP parts are needed

•At least Annual surveillance audits and triennial re-certification – a frequency likely to be higher than any excipient user could manage, even for high risk excipients

 

NBScience Auditing Body Actions

•The GDP audit report lists observations and rates findings as life threatening, critical, major or minor

•Life threatening observations are a stop point

• NBScience required to instruct the excipient supplier immediately to notify all customers of the situation

•Certification Board review audit report and findings, recommend certification if

•No life threatening critical, no major without CAPA, no minors that indicate failure of quality system element

More than a Certificate….

•A GDP Certificate is issued to the excipient supplier along with an audit report

•The excipient supplier should make the Audit Reports and GDP Certificate available to the pharmaceutical excipient user(s)

•Entire information about level of GDP of the supplier with the pharmaceuticals company for evaluation

•The Audit Report may be redacted to show that confidential information has been hidden – but substance of report will not be altered

Time and Cost

•The overall NBScience GDP audit will last 4-6 man days typically

•The cost for the audit will be at day rate (typically 1500 Euro per day, per person) (大约. 3000-5000 Euro per location)

•On top NBScience to charge a GDP certification fee of 3000 Euros every 3 年

•Surveillance audits annually will last approx. 2 天 (大约. 4000-6000 Euros per year)

•The GDP certificate needs to be renewed every 3 年

 

For a more accurate calculation of the amount we need to get the full information about warehousing location, description and employees.

例子:

Pilot audit phase – Audit for GDP (二月 2014)

•Company: X-pharma (德国, manufacture and distribution)

•6 hectare on 2 站点, 8 excipients, 165 employees on 2 站点

•Manufacture: aqueous solution, packaging in clean-rooms, lab testing

•Distribution: warehousing, shipment/delivery, re-packaging

•4 auditor man days on one site, 1 auditor day at affiliate

•2 auditor man days preparation and 20 page report

•Audit of larger site witnessed by NBScience contracted experts

•Audit at certification body offices completed

国内生产总值 ( Good Distribution Practice ) online course

 

医学大会

3) Good manufacturing practice GMP audit

“良好生产规范” 是涵盖药物剂型或药物和活性药物成分的制造和测试的质量体系的一部分, 诊断, 食品, 药品, 和医疗设备. GMP 是概述可能影响产品质量的生产和测试方面的指南. 许多国家已立法规定制药和医疗器械公司必须遵循 GMP 程序, 并制定了符合其立法的自己的 GMP 指南, 所有这些指南的基本概念或多或少都是相似的，最终目标都是保障患者的健康, 生产优质药品或医疗器械或活性药品.

虽然他们有很多, 所有指南都遵循一些基本原则.

  • 制造流程得到明确定义和控制. 所有关键流程均经过验证，以确保一致性并符合规范.
  • 制造过程受到控制, 并对流程的任何更改进行评估. 必要时验证对药物质量有影响的变化.
  • 说明和程序以清晰明确的语言编写. (良好的文档实践)
  • 操作员接受过执行和记录程序的培训.
  • 已做出记录, 手动或通过仪器, 在制造过程中，证明确实采取了规定的程序和说明所需的所有步骤，并且药物的数量和质量符合预期. 调查并记录偏差.
  • 制造记录 (包括分销) 能够以易于理解和访问的形式保留批次的完整历史记录.
  • 药品的分配将其质量风险降至最低.
  • 系统可用于召回销售或供应的任何批次的药品.
  • 对上市药品的投诉进行审查, 质量缺陷原因调查, 对有缺陷的药品采取适当的措施并防止再次发生.

GMP 指南并不是关于如何制造产品的说明性说明. 它们是制造过程中必须遵守的一系列一般原则. 当公司制定质量计划和制造流程时, 可能有很多方法可以满足 GMP 要求. 公司有责任确定最有效、最高效的质量流程.

欲了解详情，请通过电子邮件联系我们: head_office@nbscience.com

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GMP培训

 

医学大会

程序:

 GMP基本原则    

Introduction to the training course
Quality management
Sanitation and hygiene
Qualification and Validation
Complaints and recalls
Contract production and analysis
Self-inspection and Quality Audits
Personnel
Premises
Equipment
Materials
Documentation
Good Practices in Production and Quality Control
Sterile production
Active Pharmaceutical Ingredient
 GMP检查流程 

介绍 [
The role of the inspector
Preparation for an inspection
Types of GMP inspection
The inspection

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