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Food Safety Command Center 21 items

Dietary Supplement cGMP (21 CFR 111) Checklist

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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