Buyer questions · Use scenarios
What is the difference between MoCRA compliance and routine GMPC audits in US cosmetics manufacturing, and how should a factory prepare for inspections?
MoCRA mandates facility registration and product listing, while GMPC (ISO 22716) is a voluntary standard. US skincare products containing SPF must follow OTC drug rules. Factories must submit registrations via FDA Cosmetics Direct, ensuring the client acts as the 'responsible person'. ISO 22716 quality protocols support routine audits, distinguishing regulatory compliance from voluntary checks.
1Mandatory Compliance vs Voluntary Standards
MoCRA involves biennial facility registration and annual product listing. GMPC is a vendor qualification standard.
2Liability Allocation in Skincare
The 'Responsible Person' for US products must handle adverse events. Chinese factories are not listed as responsible.
3Operational Strategy for Dual Inspections
Use ISO 22716 records for routine audits; FDA portal for MoCRA; SPF products follow OTC drug requirements.
Follow-up questions
- Q:What to prepare before statutory GMP?
- A:Maintain ISO 22716 with 36 QC records; reserve slots for proposed regulatory rules.
- Q:Does GMPC audit failure cause delisting?
- A:GMPC is not regulatory. Delisting risks stem from MoCRA defects or Prop 65 litigation.
Figures sourced from:各国法规 · 美国美国护肤代工FDA 化妆品禁用与限用成分、色素添加剂配方库
Updated 2026-09-18
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