Directive 2011/62/EU - Regulatory Guideline Interpretation

Applicable Positions:

• QA (Quality Assurance): Must ensure all manufacturing, importing, and distribution processes comply with the directive's requirements.
• Regulatory Affairs: Must stay updated on amendments and implement necessary changes to maintain compliance.
• Manufacturing: Must adhere to the principles of good manufacturing practice (GMP) for active substances and excipients.
• Distribution: Must verify the authenticity of medicinal products and comply with safety feature requirements.

Work Suggestions:

• QA: Conduct regular audits to ensure compliance with GMP and good distribution practices.
• Regulatory Affairs: Monitor updates from the European Parliament and Council for any amendments to the directive.
• Manufacturing: Implement strict controls and inspections to ensure active substances meet GMP standards.
• Distribution: Develop systems for tracking and verifying the authenticity of medicinal products.

Scope of the Directive:
This directive applies to medicinal products for human use within the European Union, focusing on preventing falsified medicinal products from entering the legal supply chain. It covers various aspects including manufacturing, importation, distribution, and safety features for medicinal products.

Key Points Summary:

1. Definition of Falsified Medicinal Products: Introduces a definition to distinguish falsified products from other illegal or substandard products.
2. Safety Features: Requires the introduction of safety features for medicinal products to verify authenticity and identify individual packs, providing evidence of tampering.
3. Good Manufacturing Practice (GMP): Strengthens verification requirements for manufacturers to ensure compliance with GMP for active substances.
4. Supply Chain Reliability: Legislates that all actors in the supply chain, including brokers, must meet specific requirements to ensure reliability.
5. International Coordination: Calls for enhanced international cooperation to combat the global issue of falsified medicinal products, particularly in online sales.

Conclusion:
The Directive 2011/62/EU is a critical piece of legislation aimed at safeguarding public health by preventing falsified medicinal products from entering the legal supply chain within the EU. It places a strong emphasis on GMP, safety features, and supply chain integrity. The directive also encourages international collaboration to address the global nature of the falsified medicines threat. Above points are only a summary; for comprehensive understanding, the original directive should be consulted.

必读岗位及工作建议：

• QA（质量保证）：负责确保原料药生产全过程符合质量管理规范，监控质量体系运行。
• QC（质量控制）：负责原料药的质量检测，确保产品质量符合标准。
• 生产：负责按照GMP要求进行原料药的生产操作，确保生产过程合规。
• 工程：负责厂房设施和设备的维护保养，确保生产环境和设备符合要求。

适用范围：
本文适用于化学药领域的原料药生产，包括创新药和仿制药，适用于大型药企、跨国药企以及CRO和CDMO等企业类别，发布机构为国际通用标准。

文件要点总结：
原料药的生产质量管理规范强调了从质量管理到生产控制的全过程管理。首先，文件明确了质量管理的原则和机构职责，特别强调了质量保证和质量控制的重要性，并规定了自检、产品质量回顾以及质量风险管理的具体要求。在人员方面，规定了资质、培训和卫生要求，确保员工符合岗位需求。厂房与设施章节详细规定了设计建造、公用设施和特殊隔离要求，以保证生产环境的适宜性。设备章节则涉及设计建造、维护保养、校准和计算机化系统的要求，确保设备运行的可靠性。文件还特别提到了无菌原料药的生产特点，包括生产工艺、厂房设施设备设计、生产过程管理以及环境控制等，这些都是确保原料药质量的关键环节。

以上仅为部分要点，请阅读原文，深入理解监管要求。