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생명과학 eQMS 15개 항목

Change Control Management Checklist (ICH Q10)

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Verifies that proposed changes to processes, equipment, materials, methods, or systems are evaluated, approved, and implemented under a controlled change management system. Use for change request review.

ICH Q10 3.2.321 CFR 211.10021 CFR 820.30(i)ICH Q7 13

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Change Request Initiation

  • Is the proposed change described with justification and a unique change control number? *
  • Is the change classified (e.g., minor/major, temporary/permanent)? *
  • Is the scope of affected products, processes, and documents identified? *

Impact and Risk Assessment

  • Is the impact on product quality, safety, and efficacy evaluated using risk management? *
  • Is the effect on the validated state, specifications, and stability assessed? *
  • Are regulatory reportability/filing implications determined? *

Review and Approval

  • Is the change reviewed by relevant functions (e.g., QA, manufacturing, regulatory)? *
  • Is quality unit approval obtained before implementation? *
  • Are required actions (validation, training, document updates) defined with owners? *

Implementation

  • Are pre-implementation actions (revalidation, requalification) completed and verified? *
  • Are affected documents (SOPs, specs, batch records) updated and released? *
  • Is affected personnel training completed before the change takes effect? *
  • Record the effective implementation date.

Verification and Closure

  • Is post-implementation review/effectiveness of the change evaluated? *
  • Is the change control record formally closed with quality unit sign-off? *

Change Control Management Checklist (ICH Q10) 체크리스트 전체 다운로드

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