Chemi Pharmaceutical holds an Establishment License from Health Canada (101060-A) and Inspections from FDA (#3005933615). Our latest audits from Health Canada (June 10, 2013 and July 22, 2014) were passed successfully. We were also inspected by the FDA on April 13, 2015 with no 483 observations.
FDA Registration (inspected by FDA)
Drug Establishment License from Health Canada
COMMITMENT TO GMP
Chemi Pharmaceutical Inc. has reinforced a Standard Operating Procedure (SOP) that supports the company GMP control and regulations.
Chemi Pharmaceutical Inc. is committed to the principles of Good Manufacturing Practices in its analytical testing laboratory based on clear management direction, communications with the staff, clients and Health Canada, and the overseeing of all operations and test results of the company. The foundation of this commitment is a management structure with clear responsibilities, the appropriate level of authority and responsibilities for each manager and an independent quality structure within the company. Chemi Pharmaceutical Inc. has selected and supported technical and managerial staff members who demonstrate professionalism, loyalty, integrity and control, based on the quality system, objectives, attention to GMP, the integrity testing programs, data release procedures and traceability of data.
Chemi Pharmaceutical Inc. has reinforced its quality system for consistent processes, traceability of results to original test data and records, management review and control. The following outline of management commitment, responsibility and accountability applies to all operations and activities of Chemi Pharmaceutical Inc. to ensure compliance with regulatory requirements, Good Manufacturing Practice elements and guidelines.
Chemi Pharmaceutical has engaged a third party independent reviewer who approves every Certificate of Analysis (CoA) to ensure the test results, data integrity and GMP compliance.