AMEX Healthcare GmbH (Vienna site)

GMP Level 1

Manufacturing facilities/lines considered to be operating at an unacceptable level of GMP compliance (audits carried out by QUAMED and/or other official or recognised organisations).

GMP Level 2

Manufacturing facilities/lines considered to be not fully compliant with GMP after a QUAMED GMP audit, but with an acceptable level of risk for purchases if risk mitigation measures are implemented.

GMP Level 3

Manufacturing facilities/lines provisionally considered to be operating at an acceptable level of GMP compliance after a QUAMED GMP audit, subject to positive implementation, closure and assessment of the CAPAs, within a reasonable and agreed timeframe. Risk mitigation measures may be implemented.

GMP Level 4

– Manufacturing facilities/lines GMP approved by a SRA, by a WLA, or by WHO-PQ, or
– Manufacturing facilities/lines considered to be operating at an acceptable level of GMP compliance after a QUAMED GMP audit, or
– Manufacturing facilities/lines GMP approved by an organization officially recognized by QUAMED.

GSDP Level 1

– Distribution sites considered to be operating at an unacceptable level of GSDP compliance (Global GSDP compliance < 60%) after a GSDP technical visit by QUAMED, or
– Distribution sites considered to be operating at an unacceptable level of GSDP compliance, after a GSDP audit by QUAMED and/or other official or recognized organizations.

GSDP Level 2

– Distribution sites considered to be not fully compliant with GSDP after a QUAMED GSDP audit, but with an acceptable level of risk for purchases if risk mitigation measures are implemented.
– Distribution sites considered to be not fully compliant with GSDP after a GSDP technical visit by QUAMED (global GSDP compliance ≥ 60%), but with an acceptable level of risk for purchases if risk mitigation measures are implemented.

GSDP Level 3

Distribution sites provisionally considered to be operating at an acceptable level of GSDP compliance after a QUAMED GSDP audit, subject to positive implementation, closure, and assessment of the CAPAs, within a reasonable and agreed timeframe. Risk mitigation measures may be implemented.

GSDP Level 4

– Distribution sites GSDP/GDP approved by an SRA, or by a WLA, or
– Distribution sites considered to be operating at an acceptable level of GSDP compliance after a QUAMED GSDP audit, or
– Distribution sites GSDP/GDP approved by an organization officially recognized by QUAMED.

MQAS Level 1

Distribution sites considered to be operating at an unacceptable level of MQAS compliance, after a MQAS audit by QUAMED and/or other official or recognized organizations.

MQAS Level 2

Distribution sites considered to be not fully compliant with MQAS after a QUAMED MQAS audit, but with an acceptable level of risk for purchases if risk mitigation measures are implemented.

MQAS Level 3

Distribution sites provisionally considered to be operating at an acceptable level of MQAS compliance after a QUAMED MQAS audit, subject to positive implementation, closure and assessment of the CAPAs, within a reasonable and agreed timeframe. Risk mitigation measures may be implemented.

MQAS Level 4

– Distribution sites considered to be operating at an acceptable level of MQAS compliance after a QUAMED MQAS audit, or
– Distribution sites MQAS approved by an organization officially recognized by QUAMED.

No longer valid

Not applicable

Unknown