Clause 3: Personnel

  • 3.2.1 Organization chart: Is there a current organizational chart defining the structure and independence of the Quality and Production units?

  • 3.3 Key responsibilities: Are the responsibilities of management (3.3.1) and personnel (3.3.2) clearly defined and documented?

  • 3.4.1 Training and skills: Do personnel possess appropriate skills, and is GMP training formally documented (3.4.2)?

  • 3.4.4 Personnel training evaluations: Are personnel evaluated on their accumulated GMP knowledge during or after training?

  • 3.5.1 Personnel hygiene: Are hygiene programs established and adapted to the needs of the plant?

  • 3.5.2 Prohibited activities: Is eating, drinking, chewing, and smoking strictly prohibited in production, control, and storage areas?

  • 3.5.3 Illness and lesions: Are apparent illnesses or open lesions reported, and are affected individuals excluded from direct product contact?

Clause 4: Premises

  • 4.2 Types of area: Are areas properly segregated for materials receipt, storage, production, and QC to prevent mix-ups?

  • 4.5 Floors, walls, ceilings, windows: Are surfaces smooth, easily cleanable, and resistant to sanitizing agents?

  • 4.8 Ventilation: Is ventilation adequate for the intended operations and designed to prevent contamination?

  • 4.9 Pipework, drains and ducts: Are floor drains kept clean and designed to prevent backflow?

  • 4.13 Pest control: Is there a documented, active pest control program in place?

Clause 5: Equipment

  • 5.2 Equipment design: Is equipment designed with compatible materials (e.g., non-reactive) to prevent product contamination?

  • 5.4.1 Calibration: Are laboratory and production instruments calibrated regularly with documented logs?

  • 5.5 Cleaning and sanitization: Are equipment cleaning procedures defined, effective, and logged?

  • 5.6 Maintenance: Is there a documented preventative maintenance schedule?

Clause 6: Raw Materials & Packaging Materials

  • 6.2 Purchasing: Are materials purchased from evaluated and approved suppliers?

  • 6.3 Receipt: Are materials verified against purchase orders and placed into physical or electronic quarantine upon receipt?

  • 6.4 Release: Are materials released by the Quality unit based on established acceptance criteria before use?

  • 6.7 Water system: Is process water regularly tested for chemical and microbiological quality?

Clause 7: Production

  • 7.2.1 Manufacturing documentation: Are manufacturing operations carried out according to defined master formulas and methods?

  • 7.2.2 Line clearance: Are facilities and equipment cleared of previous product and materials before starting a new batch?

  • 7.2.4 In-process controls: Are essential parameters (e.g., time, temperature, pH) controlled and documented during compounding?

  • 7.3 Packaging operations: Are filling lines cleared and is packaging material verified before filling begins?

Clause 8 & 9: Finished Products & Quality Control Laboratory

  • 8.2 Release: Are finished products held in quarantine until officially released by Quality?

  • 9.2 Test methods: Are testing methods adequate, validated, and available in the laboratory?

  • 9.3 Out of specification (OOS): Is there a formal procedure for investigating OOS results (which also ties into Clause 10)?

  • 9.5 Retained samples: Are sufficient quantities of finished product retained in their primary packaging for the shelf life of the product?

Clause 13: Deviations

  • 13.1 Deviations: Are any deviations from specified requirements authorized with sufficient data, documented, and investigated to determine root cause and corrective action (CAPA)?

Clause 14: Complaints and Recalls (MoCRA Integration)

  • 14.1 Complaints: Are all complaints logged, investigated, and reviewed by Quality?

  • MoCRA (§ 605) Integration: Does the complaint procedure specifically trigger an FDA MedWatch 3500A submission within 15 days if the complaint meets the criteria for a Serious Adverse Event?

  • 14.2 Recalls: Is there a defined recall procedure, and are mock recalls conducted to ensure bi-directional traceability?

ISO 22716:2007 Cosmetic GMP Audit Checklist

Please note: The following checklist is not exhaustive; it serves as a foundational baseline and may require additional criteria as regulations continue to evolve. As of 2026, the FDA’s final Good Manufacturing Practice (GMP) rule under MoCRA is still pending. Until those specific federal regulations are finalized, ISO 22716 remains the industry’s de facto baseline for cosmetic facility compliance, supplemented by MoCRA's immediate statutory mandates. Please refer to the Good Manufacturing Practice (GMP) Guidelines/Inspection Checklist for Cosmetics,  FDA Cosmetic Good Manufacturing Practices, and ISO 22716:2007 for further information.