QUALITY MANAGEMENT
Quality Assurance
© 2023 MINASCENT Technologies GmbH
Minascent is a part of the
Regulatory Compliance
Quality Control
Continuous Improvement
Responsible Care
Safety, Health, Enviroment
Our Quality Assurance system can be flexibly adapted to
customer requirements. The system is IS0-9001 inspired, FDA
inspected and is certified as compliant to pharmaceutical cGMP
and feed industry FAMI-QS quality systems. The business of
registered starting materials and active pharmaceutical
ingredients for the pharmaceutical industry are managed by
our affiliate Minakem.
Regulatory compliance for feed additives was aproved by
German authority in 2013-2014 and by FAMI-QS in 2013 and
2016. Regulatory compliance for active pharmaceutical
ingredients include GMP audits in 2009, 2012 and 2015.
Successful FDA inspections took place in 2008, 2010
(Korean FDA), 2011 and 2014
Our Quality Control tests raw materials, intermediates and final
products according to the quality system appropriate to the
product in question, whether ISO-like, GMP or FAMI-QS. For
cGMP the tests are performed on qualified instruments
calibrated at defined intervals. Method validation is performed
according to ICH guidelines.
Minascent is committed to a continuous improvement approach
based on lean management and methodologies. In addition to
self-investigation, regular customer audits of our facilities and
quality system provide the opportunity to measure ourselves
against customer expectations and to continually improve the
way this feedback is collected and implemented
in our processes.
Minascent complies with applicable laws and regulations for
SEVESO-qualified operations. We maintain a management
system assuring that we protect our employees, customers,
neighbours and other stakeholders from injury. We protect and
sustain the environment through preventative environmental
protection. Minascent is certified as fulfilling the requirements of
the ISO 50001 energy management system.
The management of Minascent is responsible to assure all
components of the Minafin Group principles and rules are
respected. In application of the above commitments, the Minafin
Group as a member of ICCA has signed the Responsible Care
®
Global Charter.
© 2022 MINASCENT Technologies GmbH
Minascent is a part of the
Regulatory Compliance
Quality Control
Continuous Improvement
Responsible Care
Safety, Health, Enviroment
QUALITY MANAGEMENT
Our Quality Assurance system can be flexibly adapted to
customer requirements. The system is IS0-9001 inspired, FDA
inspected and is certified as compliant to pharmaceutical cGMP
and feed industry FAMI-QS quality systems. The business of
registered starting materials and active pharmaceutical
ingredients for the pharmaceutical industry are managed by our
affiliate Minakem.
Regulatory compliance for feed additives was aproved by
German authority in 2013-2014 and by FAMI-QS in 2013 and
2016. Regulatory compliance for active pharmaceutical
ingredients include GMP audits in 2009, 2012 and 2015.
Successful FDA inspections took place in 2008, 2010
(Korean FDA), 2011 and 2014
Our Quality Control tests raw materials, intermediates and final
products according to the quality system appropriate to the
product in question, whether ISO-like, GMP or FAMI-QS. For
cGMP the tests are performed on qualified instruments
calibrated at defined intervals. Method validation is performed
according to ICH guidelines.
Minascent is committed to a continuous improvement approach
based on lean management and methodologies. In addition to
self-investigation, regular customer audits of our facilities and
quality system provide the opportunity to measure ourselves
against customer expectations and to continually improve the
way this feedback is collected and implemented
in our processes.
Minascent complies with applicable laws and regulations for
SEVESO-qualified operations. We maintain a management
system assuring that we protect our employees, customers,
neighbours and other stakeholders from injury. We protect and
sustain the environment through preventative environmental
protection. Minascent is certified as fulfilling the requirements of
the ISO 50001 energy management system.
The management of Minascent is responsible to assure all
components of the Minafin Group principles and rules are
respected. In application of the above commitments, the Minafin
Group as a member of ICCA has signed the Responsible Care
®
Global Charter.
Quality Assurance
