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eQMS para Ciências da Vida 15 itens

Change Control Management Checklist (ICH Q10)

Este checklist está em inglês.

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? *

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