Ensign Laboratories  
 
Quality Control
Sytems
Accreditations
 
 
Quality
Accreditations
 

    TGA
Ensign is Licensed to manufacture Therapeutic Goods to the cGMP (Code of Good Manufacturing Practices) as audited regularly by the Australian Therapeutic Goods Administration, an Australian Government Authority based in Canberra. Ensign has had this accreditation since 1991 and continually improve our systems, responding to ever changing regulatory and customer requirements. (License number 189)
 
    AS/NZS ISO 9001:2000
This License issued to Ensign by SAI Global acknowledges Ensign are a Quality Endorsed Company. Ensign has been the holder of similar versions of this ISO License since 1995 and is audited twice yearly by SAI Global. (Certificate number QEC1844)
 
    HACCP
Ensign abide by the Codex HACCP (Hazard Analysis Critical Control Point) principles and are audited for certification twice yearly by NCSI (Nata Certification Services International). Ensign first applied and was successful in obtaining this License in 2003. (Reference number 262HB)
 
    APVMA
Australian Pesticides & Veterinary Medicines Authority, audit Ensign for certification yearly. Ensign has continually improved our system since implementing this License in 2001. (License number 2040)
 
    Future Accreditations
Ensign are currently preparing to obtain a conformity certification by the TGA for ISO 13485, for the manufacture of Medical Devices in Australia. Ensign's current TGA License does allow for the manufacture of Medical Devices but there has been a regulatory change which Ensign are pro-actively preparing for.
 
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