GMP compliant facility
Galenik Ecza production facility and distribution center is designed as a ISO 22716:2007 cosmetics GMP compliant complex.
Even the smallest components and equipment are chosen and installed in compliance with the highest standards of medical industry.
Choosy raw materials supply management
Galenik Ecza imports directly from top chemical companies of EU.
GMP, HACCP and ISO 9001 compliance is required for producers from Europe and USA, while ICH Q7 compliance is required for Asian producers additionaly.
GMP compliant raw material acceptance
All raw materials, equipment, packaging, and labeling materials are held in GMP compliant quarantine area with digital ambient stability control until they are sampled, tested and/or examined before they’re accepted.
Quality management team members continuously update their on-site and external training to assure highest possible up-to-date acceptance and end product quality compliance.
In-house and external laboratory tests
Product development and quality assurance tests are utilized in own laboratories conforming GMP protocols by Galenik Ecza team.
Production quality is audited and inspected by external reputable laboratories, all accredited by TURKAK (Turkish Accreditation Agency).
"Clean room" production system
Entire Galenik Ecza OTC product range is produced at clean room production line with GMP conformity.
Negative air pressure production division and clean rooms are equipped with hepa filters.
Continuous training and auditing
Production, sales and distribution team members of Galenik Ecza are trained according to GMP and the courses are updated regularly.
Independent auditors internally inspect the management and production system as well as the production facility bi-annually, while the whole quality management system is audited by authorized quality management bodies.