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Chemgineering Germany GmbH offer service "Qualification & Validation"

基本信息

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交易类型

提供服务

服务名称

Qualification & Validation

规格参数

  • 服务类型: 支持药品、活性成分、化妆品及食品符合GMP要求生产的确认与验证服务
  • 认证标准: 符合欧盟及美国食品药品监督管理局(FDA)等监管机构的严格准则
  • 设备兼容性: 涵盖设备、建筑和厂房的确认,并配备确认、验证与合规文件(包括SOP模板),确保系统经得起审计考验

其他信息

补充描述:

GMP-compliant manufacture of medicines, active ingredients, cosmetics, and foodstuffs is essential for market authorization and sale, and quality assurance is central since quality deviations directly affect consumer health. Meeting strict regulatory guidelines, such as those from the EU or US FDA, requires validating manufacturing processes and qualifying equipment, buildings, and premises. Chemgineering's experienced team develops customized measures to reach the required regulatory status, producing all relevant qualification, validation, and compliance documentation, including SOP templates, to build systems and processes that pass audits on the first attempt.
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