CGMP 与EU、WHO、FDA 的硬件对比 2020 1221

  • 制药产品走向国际高端市场,对世界主要药品管理机构和行业协会的要求熟悉,以下为网址: 药物的国际法律法规 全英文网站,为了你提高效率,给你一个免费变中文的方案https://xjzc.ink/office,点击我免费翻译官–外文网站自动翻译为中文,这是软件行为,原文含义自己负责,提高效率是没有问题的。

 

FDA基础法规(母法)是联邦食品药品化妆品法及修正案,第21册为食品和药品.

其中CGMP相关部分有:

  • Part 110:食品CGMP
  • Part 111:饮食补充剂CGMP
  • Part 210:药品CGMP通则
  • Part 211:人/兽用药制剂CGMP
  • Part 225:加药饲料CGMP
  • Part 226:A类加药物品CGMP
  • Part 606:血液和血液成分CGMP

 下图为自动变为中文,速度很快

  

 

中国GMP 与EU、WHO、FDA 的确认与验证对比

国家食药总局于2015年发布《计算机化系统》和《确认与验证》两个附录,作为《药品生产质量管理规范(2010年修订)》配套文件,自2015年12月1日起施行。

验证(Validation):证明任何操作规程(或方法)、生产工艺或系统能够达到预期结果的一系列活动。中国GMP 第十四章 附则[1]

Validation studies should reinforce Good Manufacturing Practice and be conducted in accordance with defined procedures . Results and conclusions should be recorded.PIC/S GMP Guide – Part I[2]


中国GMP 第七章 确认与验证[3]
第一百三十八条 企业应当确定需要进行的确认或验证工作,以证明有关操作的关键要素能够得到有效控制。确认或验证的范围和程度应当经过风险评估来确定。
第一百三十九条 企业的厂房设施设备检验仪器应当经过确认,应当采用经过验证的生产工艺操作规程检验方法进行生产、操作和检验,并保持持续的验证状态。

中国GMP 确认与验证附录[4]
第一条 本附录适用于药品生产质量管理过程中涉及的所有确认与验证活动。

FDA CFR 211[5]
Process validation (including process qualification) is legally enforceable under section 501(a)(2)(B) of the Act. FDA regulations require that process validation procedures be established and followed (§ 211.100) before a batch can be distributed (§§ 211.22 and 211.165). [6]

EU GMP Chapter 5 Production[8]
5.21 Validation studies should reinforce Good Manufacturing Practice and be conducted in accordance with defined procedures . Results and conclusions should be recorded.
5.22 When any new manufacturing formula or method of preparation is adopted, steps should be taken to demonstrate its suitability for routine processing. The defined process, using the materials and equipment specified, should be shown to yield a product consistently of the required quality.

EU GMP Annex 15 Qualification and Validation[9]
1.This Annex describes the principles of qualification and validation which are applicable to the facilities, equipment, utilities and processes used for the manufacture of medicinal products and may also be used as supplementary optional guidance for active substances without introduction of additional requirements to EudraLex, Volume 4, Part II. It is a GMP requirement that manufacturers control the critical aspects of their particular operations through qualification and validation over the life cycle of the product and process. Any planned changes to the facilities, equipment, utilities and processes, which may affect the quality of the product, should be formally documented and the impact on the validated status or control strategy assessed.

 

WHO GMP[10]
4.Qualification and validation
4.6 The commitment to maintain continued validation status should be stated in the relevant company documentation, such as the quality manual or validation master plan.
4.7 The responsibility of performing validation should be clearly defined.
4.8 Validation studies are an essential part of GMP and should be conducted in accordance with predefined and approved protocols.
4.9 A written report summarizing the results recorded and the conclusions reached should be prepared and stored.
4.10 Processes and procedures should be established on the basis of the results of the validation performed.
4.11 It is of critical importance that particular attention is paid to the validation of analytical test methods, automated systems and cleaning procedures .

Good manufacturing practices: guidelines on validation[11]
3. Computerized system validation protocols and reports

  • Validation protocol
  • Validation report
  1. Supplier management
    5. Requirements specifications
  • User requirements specifications
  • Functional specifications
  1. System design and configuration specifications
    7. Design qualification
    8. System development and project implementation
  • Supplier-provided systems
  • Custom-developed systems
  • Preparation for the system qualification phase
  1. Installation qualification
    10. Operational qualification
    11. Standard operating procedures and training
    12. Performance qualification and user acceptance testing
  • Legacy systems
  1. System operation and maintenance
  • Security and access control
  • Operation and maintenance
  • Data migration
  • Periodic review
  1. System retirement
  2. 实施指导

确认与验证
验证主要考察生产工艺、操作规程、检验方法和清洁方法等。 中国GMP(2010版)对计算机化系统进行了定义,其中虽未明确规定验证的要求 , 但在制药行业中通常认为计算机化系统也属于验证的范畴。自 2015年12月1日起施行《计算机化系统》和《确认与验证》两个附录

技术转移验证
验证作为技术转移一部分,接受方应该在技术转移开始阶段就应该着手考虑验证。技术转移验证应该考虑以下方面:系统确认(例如设备、设施、通用工程、自控、计算机);清洁验证分析方法验证等。 参考药品GMP指南 质量管理体系 3.5.1 技术转移[13]

电子表格验证

生产企业的检验记录采用Excel电子版 , 记录中的计算部分和安全必须经过验证。
(1)使用Excel创建的用于计算检验结果的检验记录(相当于单项检验报告 , 其检验过程的相关内容记录在实例4的检验记录)
(2)公式的验证
(3)电子版文件的安全性验证

  1. 参考资料
  2. 中国GMP 第十四章 附则
  3. PIC/S GMP Guide – Part I
  4. 中国GMP 第七章 确认与验证
  5. 中国GMP 《计算机化系统》和《确认与验证》两个附录
  6. FDA CFR 211
  7. FDA Guidance Process Validation: General Principles and Practices
  8. FDA Guidance Process Validation: General Principles and Practices
  9. EU GMP Chapter 5 Production
  10. EU GMP Annex 15 Qualification and Validation
  11. WHO GMP
  12. Good manufacturing practices: guidelines on validation
  13. 药品GMP指南 质量管理体系7 确认与验证
  14. 药品GMP指南 质量管理体系5.1 技术转移
  15. 药品GMP指南 口服固体制剂4 包装验证
  16. 质量控制实验室 4 物料和产品的检验 实例 5

 

往期目录  (关注公众号 Aa制药设备技术   点击超链接跳转)

 

设备新大学生线上培训

操作 维护管理

培训二   生产设备验证           (升级版 11.5

培训三    降低设备故障率

培训四    设备确认

读《药品记录与数据管理》

 

案例一、浅议无菌药品配液系统设备的相关问题

案例二  原料药无氧动态真空干燥技术与设备

案例三、 干热灭菌器升降温速度及 一致性评价

案例四、制粒机温度均匀度及产品质量一致性评价

开拓案例五、国际化技术

Posted in GMP, pda, 一致性评价, 数据完整性, 药品记录.

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