Key obligations

• Write and maintain procedures for sanitation, equipment care, deviations, and change control.
• Risk-rank and audit suppliers, contract manufacturers, and labs that touch the product.
• Train GMP roles, keep completion records, and store controlled documents in a governed system.
• Track FDA rulemaking and remediate gaps before inspections start.

Evidence regulators expect to see

• Facility certifications (ISO 22716, cGMP audits) and remediation logs.
• Supplier quality agreements and audit schedules.
• Training records with completion dates, curricula, and role coverage.
• Deviation/CAPA (corrective and preventive action) reports with closure proofs.

Intake sections that populate this section

• Facilities
• Suppliers & Testing
• Training & Docs
• Policies & References

Relevant SOP templates

• GMP Preparation SOP
• Training & Documentation SOP

Risk of non-compliance

• Form 483 observations and warning letters once FDA audits begin.
• Production or launch delays caused by unqualified suppliers.
• Retailer delisting when they see missing quality controls.

Further reading

• 21 U.S.C. § 364b – Good manufacturing practice
• FDA Listening Session on Cosmetic GMP
• Draft Guidance: Cosmetic Good Manufacturing Practices