工艺验证的GMP要求.pdfVIP

GMP 工艺验证的 GMP 要求 工艺验证的 要求 Inspection of Process Validation Inspection of Process Validation 工艺验证的检查 工艺验证的检查 GMP Requirements for Process Validation GMP Requirements for Process Validation 工艺验证的GMP 要求 工艺验证的GMP 要求 The expectations placed upon the manufacturer The expectations placed upon the manufacturer regarding GMP compliant execution of process regarding GMP compliant execution of process validations can be categorized into three levels: validations can be categorized into three levels: 对生产商提出的符合 GMP 标准的工艺验证执行期望可分 对生产商提出的符合 GMP 标准的工艺验证执行期望可分 为三个级别: 为三个级别: The quality assurance system must include GMP The quality assurance system must include GMP compliant requirements for process validation. compliant requirements for process validation. 质量保证体系必须包括符合 GMP 标准的工艺验证要求。 质量保证体系必须包括符合 GMP 标准的工艺验证要求。 Process validations must be executed Process validations must be executed according to the general requirements of the QS according to the general requirements of the QS system. system. 工艺验证必须根据质量体系的一般要求执行。 工艺验证必须根据质量体系的一般要求执行。 The product and process-specific validation The product and process-specific validation design must be appropriate for the specific risks design must be appropriate for the specific risks to the patient health and be scientifically justified. to the patient health and be scientifically justified. 对患者健康的特定风险具有适当的产品和工艺相应的 对患者健康的特定风险具有适当的产品和工艺相应的 验证设计, 并科学合理。 验证设计, 并科学合理。