İmaretcioglu Limited, Samsun, Turkey
Task
• Qualification of a computerized system for Shimadzu HPLC
• Qualification of the ampoule filling machine
• Qualification of ampoules filling machine
• GMP Audits
• Support in GMP certification
Solution
• Qualifications were performed
• Based on recommendations from consultants, many processes have been improved
• GMP Compliance Certificate was obtained
• GMP Certificate issued by the State Medicines Service of Ukraine was recognized by the Canadian Regulatory Authority