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Cosmetics GMPs

GMP for Cosmetic Industry

Training Curriculum

  • The 11 General Orders of GMP
    - Writing Procedures
    - Following Procedures
    - Good Documentation Practice
    - Validation
    - Design/Build Facilities
    - Maintain Facilities
    - Training, Education and Experience
    - Sanitation and Housekeeping
    - Control for Quality
    - Audit for Compliance
    - Prepare for Battle - Recall/Traceability

  • Cosmetic Good Manufacturing Practices

  • 21 CFR Part 700 General Requirements

  • 21 CFR Part 701 Cosmetic Labeling

  • 21 CFR Part 710 Registration

  • Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)

  • 21 CFR Part 11 Electronic Records; Electronic Signatures

  • 21 CFR Part 11 History and Overview

  • 21 CFR Part 11 a) - k) Requirements

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Good Cosmetics Manufacturing Practice Training Objectives

One (1) Day GMP Basics:

Good Cosmetics Manufacturing Practice Training Objectives

Two (2) Day Basics Include additional controls under 21 CFR Parts 210/211 Pharmaceutical GMPs:

  • Organizational & Management Responsibilities 

  • Document Control Program 

  • Employee Orientation, Quality Awareness, and Job Training

  • Plant Safety and Security 

  • Internal Quality/GMP Training Session Program 

  • Quality Cost Program 

  • Design Control 

  • Facility Design and Layout 

  • Environmental Control Program 

  • Facility Maintenance and Good

  • Housekeeping Program 

  • Outside Contractor Control Program

  • Equipment Design and Placement

  • Equipment Identification, Equipment Maintenance & Cleaning 

  • Measurement Equipment Calibration Program 

  • Equipment Qualification Program 

  • Material/Component Specification and Purchasing Control 

  • Material/Component Receipt, Inspection, Sampling, and Laboratory Testing 

  • Material Component Storage and Handling 

  • Inventory Control Program Vendor (Supplier) Control Program 

  • Material/Component/Label Verification, Storage, and Handling

  • Equipment/Line/Area Cleaning, Preparation, and Clearance

  • Operational Process Validation and Production Change Order Control 

  • In-Process Inspection, Sampling, and Laboratory Control

  • Reprocessing/Disposition of Materials 

  • Finished Product Verification, Storage, and Handling 

  • Finished Product Inspection, Sampling, Testing, and Release for Distribution 

  • Distribution Controls

  • Complaint Handling and Customer Satisfaction Program

21 CFR Part 11 Basic Overview

Part 11.10 Sections a) - k) (a) Validation 

(b) Copies of records 

(c) Protection of records 

(d) Limiting system access 

(e) Audit trails 

(f) Operational system checks 

(g) Authority checks (h) Device checks 

(i) Education, Training, Experience 

(j) Policies and Procedures 

(k) Systems documentation 

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