食品安全指挥中心 21 项
Dietary Supplement cGMP (21 CFR 111) Checklist
此检查清单为英文版。
Assess dietary supplement manufacturing, packaging, labeling, and holding operations against current good manufacturing practice requirements.
21 CFR 111cGMPFDA
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Quality Control Operations
- Are quality control operations established and responsibilities assigned to qualified personnel? *
- Does QC review and approve all master manufacturing and batch production records? *
- Does QC approve or reject each unique formulation and manufacturing process? *
- Are material review and disposition decisions documented by QC? *
Components & Specifications
- Are identity specifications established for each component and confirmed by at least one appropriate test before use? *
- Are component specifications for purity, strength, and composition established? *
- Are limits established for contaminants that may adulterate the finished product? *
- Are certificates of analysis, where relied upon, qualified through supplier verification? *
Master & Batch Production Records
- Is a master manufacturing record prepared for each unique formulation and batch size? *
- Does the master record identify specifications for each control point, step, or stage? *
- Is a batch production record prepared for each batch that follows the master record? *
- Does the batch record document actual results and observations, including who performed each step? *
Finished Product & Testing
- Are finished product specifications established for identity, purity, strength, and composition? *
- Is each finished batch verified against specifications before release (testing or exemption per 111.75(c))? *
- Are reserve samples of each finished batch retained for the required period? *
Facilities, Equipment & Personnel
- Are employees supervised by qualified personnel and trained on cGMP duties they perform? *
- Is equipment cleaned, maintained, and calibrated on a defined schedule? *
- Are physical plant sanitation and pest control programs in place? *
Complaints & Returns
- Are product complaints reviewed by a qualified person to determine whether they relate to a cGMP failure? *
- Are complaint investigation records, including findings and follow-up, maintained? *
- Are returned dietary supplements identified, quarantined, and dispositioned by QC? *
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