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Life-Sciences eQMS 20 items

Technology Transfer Readiness Checklist (ICH Q10 / WHO TRS 961)

Assesses readiness to transfer a product and process between development and manufacturing or between sites, ensuring knowledge, methods, and validation are in place. Use for sending/receiving site transfer gating.

ICH Q10WHO TRS 961 Annex 721 CFR 211

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Governance and Transfer Plan

  • Is an approved technology transfer protocol/plan in place defining scope, roles, and acceptance criteria? *
  • Are sending and receiving unit responsibilities (RACI) defined? *
  • Is a gap assessment completed between sending and receiving site capabilities? *
  • Is a quality agreement in place where the transfer crosses legal entities? *

Product and Process Knowledge Transfer

  • Are the process description, CPPs, CQAs, and control strategy transferred? *
  • Is development history including design space and risk assessments provided? *
  • Are master batch records adapted and approved for the receiving site equipment? *
  • Are raw material and component specifications and suppliers aligned? *

Analytical Method Transfer

  • Is a method transfer protocol executed (comparative testing, co-validation, or justified waiver)? *
  • Do method transfer results meet the pre-defined acceptance criteria? *
  • Are reference standards, columns, and reagents available at the receiving lab? *
  • Are receiving-site analysts trained and qualified on the methods? *

Facility, Equipment, and Validation

  • Is the receiving-site equipment qualified and appropriate for the process scale? *
  • Are engineering/demonstration batches evaluated before process validation? *
  • Is process validation (PPQ) planned or executed at the receiving site? *
  • Is cleaning validation for the transferred product addressed at the receiving site? *

Regulatory and Closeout

  • Are required regulatory submissions/variations for the site change identified and filed? *
  • Is a transfer summary report documenting outcomes and open items approved? *
  • Are residual actions tracked to closure with owners and due dates? *
  • Quality approval of transfer completion. *

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