关于PDA适用性的变化和拟议的过程开发方法的案例研究技术报告第1号 89:疫苗开发和生命周期管理的策略
Cristiana Campa1, Didier ClÉnet2, Jane Halpern3
1GSK.
PDA journal of pharmaceutical science and technology
|September 24, 2024
概括
本文解释了疫苗开发和生命周期管理的策略,使用七个案例研究来说明控制策略和监管合规等关键概念,用于不断发展的制造计划.
科学领域:
- 疫苗学 疫苗学 疫苗学
- 制药制造业 制药制造业 制药制造业
- 监管科学 监管科学
背景情况:
- 疫苗是具有较长生命周期的复杂产品,需要不断更新制造.
- 随着监管期望的不断变化,疫苗开发和生产需要适应性战略.
研究的目的:
- 为疫苗开发者和制造商提供背景和实际指导.
- 用现实世界的场景来说明疫苗生命周期管理的关键方面.
主要方法:
- 关于PDA技术报告第1号的讨论 89 (TR 89) 关于疫苗开发和生命周期管理.
- 分析了七个案例研究,涵盖了各种制造和开发情况.
- 应用TR 89概念,包括控制策略,可比性和监管考虑.
主要成果:
- 将TR 89原则应用于特定的疫苗制造挑战的演示.
- 实践中的控制策略,先验知识和基于风险的方法的说明性示例.
- 关于利用制药质量系统和ICH Q12用于生命周期管理的指导.
结论:
- 有效的疫苗生命周期管理需要强有力的控制策略和遵守监管标准.
- 案例研究强调了基于风险的方法和可比性评估的实际应用.
- TR 89为导航疫苗开发和管理整个产品生命周期的变化提供了有价值的框架.
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