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Quality

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Quality Assistance has established a corporate governance structure which supports its commitments to public health, and quality is one of the criteria on which it is founded.
An independent Quality Assurance Unit manages the Quality Management System, meeting ongoing challenges and improving processes and procedures.
Through our Quality and Technical Agreements clearly defining responsibilities, restrictions, regulations and the technical aspects of projects, we ensure that our clients receive a service which fulfils their requirements of a consistently high standard of quality.

 


 

gmp-quality-assistance

GMP Compliance
Good Manufacturing Practice

In accordance with the Royal Decree of 22/09/1966*, Quality Assistance is certified by the Belgian Federal Agency for Medicines and Health Products to perform the analysis of medicinal products.

* Requirements and methods for the legal recognition of laboratories performing analyses and quality control of medicinal products.

 


 

GLP Compliance
Good Laboratory Practice

Quality Assistance is authorized by the Belgian authorities (Scientific Institute of Public Health) to carry out toxicity studies, residue studies, analytical and clinical chemistry testing, and pharmacokinetic studies according to the requirements of Good Laboratory Practice (GLP) - Directive of the European Commission 2004/9/EEC.

 


 

GCLP Compliance
Good Clinical Laboratory Practice

Quality Assistance has adapted its quality system to meet the requirements of sponsors who need the analysis of their samples from clinical trials to be done in accordance with GCLP (Good Clinical Laboratory Practice).

GCLP is based on guidelines ICH E6 (Guideline for Good Clinical Practice), ICH E8 (General Considerations on Clinical Studies),  WHO GCLP (Good Clinical Laboratory Practice - WHO 2009) and EMA/INS/GCP/532137/2010 “Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples”.

 


 

GCP Compliance
Good Clinical Practice

Quality Assistance has adapted its quality system to meet the requirements of sponsors who need the analysis of their samples from clinical trials to be done in accordance with GCP (Good Clinical Practice).

 


 

EMA
The European Medicines Agency

The European Medicines Agency (EMA), located in London, is responsible for the scientific evaluation of applications for European Union (EU) marketing authorisations for human and veterinary medicines in the centralised procedure.

 


 

FDA Inspection
The US Food and Drug Administration

The US Food and Drug Administration has successfully inspected Quality Assistance. Accordingly, Quality Assistance has been accepted and registered with the FDA as a contract pharmaceutical testing facility (FDA-FEI number 3002367943).

 


 

PMDA Inspection
Pharmaceuticals and Medical Devices Agency

In March 2009, Quality Assistance was successfully inspected by the Pharmaceuticals and Medical Devices Agency (Japan) and received GMP compliance certification from the Japanese authorities.

 


 

ANVISA Inspection
Agencia Nacional de Vigilancia Sanitaria (Agency of Brazil)

ANVISA successfully inspected Quality Assistance in 2012 to verify compliance with Good Practices in Bioavailability/Bioequivalence of Medicines, in accordance with Law N°9,782/99 and Resolution R.D.C./ANVISA N° 103, of 08 May 2003. Quality Assistance is registered with ANVISA as a contract Bioequivalence facility.

 

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