Compliance with the international guidelines, standards and directives applicable to the production of cosmetics is essential for commercial success and consumer safety. As in the pharmaceutical, medical device and food industries, cosmetic products and their production are constantly inspected to ensure they consistently meet certain standards.
The ISO 22716 standard is a combination of rules that combine ISO 9001 and GMP guidelines. A cosmetic manufacturer that has the ISO 22716 standard is obliged to strictly comply with a wide variety of rules, from the selection of raw materials to the number of particles that must be present in the production environment, from the microbiological tests to the quality of the water used, from the qualifications of the personnel it employs to the production records it keeps.
This course has been designed to provide an essential overview of GMP in the production and manufacture of cosmetics. It will be particularly useful for Pharmaceutical and Biotech companies/personnel considering entering this market and it will also provide an opportunity for those who need to refresh their knowledge about the requirements.
The programme will cover all aspects of the ISO 22716 standard and will include practical application examples. The critical points to be considered in the cosmetic production process will be addressed and there will be plenty of time to discuss the complexities involved.
Benefits of Attending
- Understand how to comply with International Cosmetics Directives and Legislation
- Refresh your knowledge about the current Cosmetics GMP requirements
- Know how to establish an ISO 22716-compliant Cosmetics Quality Management System
- Learn how to qualify manufacturing areas: water, HVAC, Gas systems
- Know how to calibrate, clean, maintain, and qualify a system and equipment
- Understand how to validate processes, cleaning, and computerised systems
- Know how to handle an Out of Specification (OOS), an Out of Trend (OOT), deviations, and unexpected incidents
- Hear how to launch a root cause analysis, and prevent human errors
- Gain a better understanding of which elements can trigger a change control initiative
Certification:
- CPD: 12 hours for your records
- Certificate of completion
Agenda
This course runs from 12:30-16:45
An Overview of International Cosmetic Regulations and Standards
- EU Cosmetic regulation (EC No 1223/2009)
- ISO 9001
- GMP guidelines for cosmetics
- ISO 22716
Establishing an ISO 22716 Quality Management System:
Personnel
- Organisation chart
- Management responsibilities
- Training
- Personnel hygiene and health
- Visitors and untrained personnel
Premises
- Material and personnel airlocks
- Floors, walls, ceilings, windows
- Washing and toilet facilities
- Lightning
- Ventilation
- Pipework
- Cleaning and sanitisation
- Maintenance
- Pest control
Equipment
- Equipment design and selection
- Installation
- Calibration
- Cleaning and sanitisation
- Maintenance
- Qualification
- Back-up systems
Workshop 1 - Manufacturing Equipment Qualification
Raw Materials and Packaging Materials
- Principle
- Purchasing
- Receipt
- Identification and status
- Release
- Storage
- Re-evaluation
- Water systems
Q & A
Production
- Principle
- Manufacturing operations
- Start-up checks
- Assignment of a batch number
- In-process operations
- Bulk product storage
- Packaging operations
- Validation
Finished Product
- Principle
- Release
- Storage
- Shipment
- Returns
Quality Control Laboratory
- Principle
- Test Methods
- Acceptance criteria
- Results
- Out of Specifications (OOS) and Out of Trends (OOT)
- Reagents
- Solutions
- Reference standards
- Culture media
- Sampling
- Retain sample
Treatment of Product that is Out of Specification (OOS)
- Rejected finished products
- Bulk products
- Raw materials and packaging materials
Workshop 2 - How to Select a Raw Material Supplier?
Wastes, Subcontracting, Deviations, Compliance, Recalls, Change Control, Internal Audit, Documentation
- Principle
- Types of waste
- Types of subcontracting
- Deviations
- Root Cause Analysis
- Human Error Reduction
- Corrective and Preventative Actions (CAPAs)
- Product complaint
- Product recall
- Change control
- Internal audit
- Documentation requirements
- Health Safety and Environmental (HSE) and Cosmetics Manufacturing
Q & A and Key Take Away Messages
Speakers
Mustafa Edik,
Independent GMP Consultant and AuditorAfter graduating as a Chemist from university, Mustafa began his 25 year plus career as a Laboratory Supervisor at Bayer, a German Pharmaceutical Company. After 15 years of working as a Quality Assurance Assistant Manager, Laboratory Supervisor, Pharmaceutical Quality Management Systems, and GMP Lead Auditor, he decided to continue his career as a Consultant. He has served the Turkish Atomic Energy Authority (TAEA) as Principal GMP Auditor and Consultant for 6 years. TAEA was audited by the Republic of Turkey Ministry of Health and granted GMP Certificate for 5 Radiopharmaceuticals. This success has won great acclaim from all health authorities and industry.
He has prepared and presented various training courses and workshops to more than 8000 individuals from 150 International and local Pharmaceutical, Medical Device, and Cosmetics companies on GMP, GDP and Pharmaceutical Quality Management Systems. He has taken part in several International Pharmaceutical Facility Establishment projects as GMP Consultant and has also set up various Quality Management Systems for Local Pharmaceutical and Medical Device Companies.
While he was the Vice President of Quality and Technical Operations at a Quality Academia Training and Consultancy firm, he acquired and converted it into a 100 % Turkish Company. As the only IRCA Certificated Pharmaceutical Quality Management Systems and GMP Lead Auditor in Turkey, he currently conducts API, Excipient, Packaging Materials Suppliers and Manufacturers, Third Party Logistics Service Providers, Sterile and Non-Sterile Manufacturing Facilities Audits according to FDA, EMA, PIC /S, TMMDA, MHRA, TGA Health Canada, and WHO regulations and guidelines.
He finished his second university degree in Biopharmaceutical Sciences BSc (Hons) at Atlantic Technological University - Ireland. He is the author of chapter 6 of the book published by PDA named “Good Distribution Practices” and he is preparing his latest book on ‘GMP Audits’ which will be published by Taylor & Francis in 2023.
Who Should Attend
Personnel from the following departments:
- Quality Assurance and Quality Control
- Validation
- R & D
- Audit
- Regulatory
- IT
- Warehouse and supply chain
- Engineering
- Procurement
