E Production Process Controls Validation validation Design QualificationDQ

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E. 제조 및 공정 관리 (Production & Process Controls)

E. 제조 및 공정 관리 (Production & Process Controls)

Validation • 검증의 요소 – 기기 validation • Design Qualification(DQ) • Installation Qualification(IQ) •

Validation • 검증의 요소 – 기기 validation • Design Qualification(DQ) • Installation Qualification(IQ) • Operational Qualification(OQ) – 공정 validation • Performance Qualification(PQ) • Validation Report • Revalidation

Validation Steps Validation Master Plan Validation Protocol Validation Study Validation Report Writing SOP Documented

Validation Steps Validation Master Plan Validation Protocol Validation Study Validation Report Writing SOP Documented plan Step by Step At least 3 times consecutively Conclusion Easy to follow

Validation • 세척검증 – 세척을 위한 표준작업서 – Challenge materials – Sampling methods –

Validation • 세척검증 – 세척을 위한 표준작업서 – Challenge materials – Sampling methods – 분석 방법의 민감성 – 허용한계 – Efficiency of recovery

환경 모니터링 (Environmental Monitoring) • Microbiological quality – 공기 üPassive sampling üActive sampling –

환경 모니터링 (Environmental Monitoring) • Microbiological quality – 공기 üPassive sampling üActive sampling – 표면 – Identification of the recovered microorganisms – 배지의 quality • Particulate quality

F. Packaging and Labeling Control

F. Packaging and Labeling Control

만기일자(Expiration Dating) • 제품에는 만기일자를 포함해야 한다. • Expiration information for both the reconstituted

만기일자(Expiration Dating) • 제품에는 만기일자를 포함해야 한다. • Expiration information for both the reconstituted & unreconstituted products • 제조일자의 결정

G. 기록과 보고서 Records and Reports

G. 기록과 보고서 Records and Reports

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