| Address: | 2750 Carrera 44 Medellín, 050021 Colombia |
| City: | Medellin |
| Country: | Colombia |
| Parent organisation: | Laboratorios Ecar S.A |
Assessments
| Document | Type | Date | Expiry |
|---|---|---|---|
 | QUAMED GMP audit | May 14, 2024 | May 13, 2027 |
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.