LEARNING OUTCOMES
The aim of the course is for students to understand the basic principles of Good Manufacturing Practice «GMP» for the manufacturing of cosmetic products in industry.
The goal of the course is to teach students the basic rules of cosmetics production on an industrial scale according to the requirements of the National Organization for Medicines (EOF) and the EU, and to ensure that consumers will get a legitimate quality product.
Learning outcomes
After the end of the course students will be able to know:
- The basic principles for the correct Production Process in the Industry (Cosmetic Plants).
- The requirements of the Auditing Authorities and the Quality Assurance Management System (QA) for the quality control and assessment of the manufactured cosmetic products.
- The proper compliance and observation of the necessary legal procedures and the documentation of the Good Manufacturing Practice «GMP» in the Cosmetic Plants for the audits, by National Organization for Medicines (EOF), other companies and international organizations (ISO).
- The necessary criteria and obligations to support the position in the industry, as a Responsible Cosmetic Scientist in Manufacturing & Quality Control/Assurance of cosmetics and medical devices products for the National Authorities (EOF).
SYLLABUS
1. Manufacturing obligations of Industry according to European Regulation for Cosmetics (EC) 1223/2009 and National Organization for Medicines (EOF).
2. Basic principles and criteria of International Organization for Standardization (ISO) 9001:2015, 22716:2008, for Manufacturing, Research, Quality control, Quality Assurance of cosmetics.
3. General Principles of Good Manufacturing Practice «GMP». Procedures, Standard Operating Procedures (SOP). Instructions. Standards. Protocols. Methods. Archives.
4. Personnel. Facilities. Requirements and specifications of the Hellenic & European Pharmacopoeia for air (overpressures, under pressures, classification of levels A,B,C,D,E), water (deionized, purified, air conditioning (temperature, humidity, air exchange)
5. Raw materials. (receipt-control-release). Recording and traceability methods. Analytical identification methods. Certificates of analysis. Release systems to Production.
6. Packaging Materials. (receipt-control-release). Sample standardization and quality control methods.
7. Hygiene. Basic rules of hygiene. Appropriate clothing in the production-packaging
areas. Rules for observing personal and group cleaning. Rules for avoiding microbiological (visible and invisible) contamination.
8. Equipment. Necessary technical characteristics of production vessels and packaging machines. (mixers-homogenizers, filling-packing machines for vials, jars, labels, carton tubing filling machines, etc.).
9. Final Products. Production-Filling-Final Packaging Methods. Control-Release of final products. Traceability methods of Batch No of products.
10. Methods of recording and keeping records of production process and corresponding certificates of analysis.
11. Storage-Distribution. Rules of good storage-distribution practice. Adherence to the «First in First out» import system (FIFO) of raw materials, packaging materials, semi-finished and finished products. Planning System (ERP), Supply Chain of materials. Evaluation of Suppliers.
12. Management of Non-Compliant Products. Complaints. Withdrawals. Self-inspections. Corrective actions. Change control.
13. Statistical Review of the production process and the quality assurance system of the Cosmetics Production (waste, procedures, complaints, services, controls, returns, etc.)
14. Environmental Quality System. Regulation, Specifications, Limits according to EU Regulation of cosmetics for Good Manufacturing Practice «GMP».