생명과학 eQMS 14개 항목
Contract Manufacturer (CMO) Oversight Checklist
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Confirms that outsourced manufacturing at a contract organization is governed by a quality agreement, ongoing performance oversight, and defined responsibilities between contract giver and acceptor. Use to audit CMO governance.
ICH Q1021 CFR 211EU GMP Chapter 7
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Selection and Qualification
- Was the CMO qualified through an on-site audit before commencing outsourced GMP activities? *
- Is the CMO's regulatory and inspection history evaluated? *
- Is the CMO's capability and capacity assessed for the specific product and process? *
Quality Agreement
- Is a written quality agreement in place that clearly allocates GMP responsibilities? *
- Does the agreement define who has final batch release/disposition authority? *
- Does the agreement address change control, deviations, complaints, and recalls? *
- Is the quality agreement kept current and periodically reviewed?
Ongoing Oversight
- Are periodic audits or requalification of the CMO performed on a risk-based schedule? *
- Are CMO performance metrics (deviations, OOS, complaints, on-time delivery) monitored? *
- Are batch records and testing data reviewed by the contract giver before disposition? *
- Are person-in-plant or virtual oversight mechanisms used where warranted?
Change and Event Management
- Is the contract giver notified and required to approve changes affecting product quality? *
- Are CMO deviations and investigations shared and assessed for product impact? *
- Is CMO data included in the annual product quality review? *
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