Good Manufacturing Practice (GMP)

ISO 22716:2007 – Cosmetic Good Manufacturing Practice

Compliance with the standard is ensured by inspecting and verifying the following areas:

• Personnel
  • Appropriate qualifications and experience of production and quality supervisors
  • Quality Assurance organizational unit is clearly separated from other operating departments
  • Continuous personnel training in Good Manufacturing Practice
  • Personal hygiene programs established and consistently enforced
  • Procedures in place to exclude sick or injured personnel from production areas
  • Clean protective clothing and gear worn by personnel handling cosmetic raw materials and bulk products
  • Eating, drinking, and smoking strictly confined to designated zones
• Premises and Facilities
  • Facilities designed and maintained to be easily cleaned, sanitized, and to safeguard product integrity
  • Adequate space allocated for manufacturing, storage, receiving, and dispatch
  • Smooth, impervious, easily cleanable, and well-maintained walls and flooring
  • Windows are kept closed; external opening windows fitted with proper screening and filtration
  • Sufficient water supply, sanitary facilities, floor drains, and drainage systems
  • Documented cleaning, sanitation, and pest control programs implemented and verified
• Equipment
  • Major manufacturing equipment clearly identified
  • Equipment is clean, easily cleanable, and sanitized
  • Processing, transfer, and storage utensils made of suitable corrosion-resistant materials
  • Measuring and testing instruments regularly calibrated
  • Preventive maintenance systems in place; procedures to quarantine defective machinery
  • Equipment operated strictly by authorized personnel
• Raw Materials and Packaging Materials
  • Approved supplier evaluation programs; incoming materials inspected upon receipt
  • Consignment and delivery documentation verified
  • Prevention of unauthorized or non-certified materials from entering production
  • Storage segregated and controlled to prevent cross-contamination and mix-ups
  • Containers kept tightly closed; packaged materials stored off the floor on pallets
  • Raw materials sampled and tested against contamination and release criteria
• Production & Processing
  • Standard operating procedures implemented across all stages of production
  • Pre-operational line clearance and check procedures completed before batch startup
  • Strict control and traceability of manufacturing batch numbers
  • Machinery, utensils, and containers thoroughly cleaned, checked, and maintained
  • Only released and approved starting materials utilized
  • Raw material weighing verified by an independent secondary operator
  • Returned finished goods inspected for quality degradation and contamination
• Finished Goods
  • Storage, handling, and distribution designed to preserve product quality
  • Final release inspection performed prior to shipment
  • Quarantine, approved, rejected, and returned products segregated physically or electronically
  • Regular inventory audits and stock rotation
  • Labeling and artwork compliance verification
• Quality Control (QC)
  • Testing and acceptance testing of starting raw materials, in-process samples, and finished batches
  • Retention, storage, and re-testing procedures for reference samples
  • Routine testing and quality monitoring of process water (especially as an ingredient)
  • Stability testing and periodic ongoing shelf-life evaluations
• Other Mandatory Quality Areas:
  • Management of rejected materials and out-of-specification results
  • Handling of manufacturing by-products and waste
  • Qualification and management of subcontracted manufacturing and testing
  • Deviation handling and complaint management
  • Change control management procedures
  • Internal audits (self-inspections)
  • Documentation and record retention