Quality Assurance

Quality Assurance

Quality Assurance

 
 
Quality Assurance SYSTEM
 

 Drug Research Centre is responsible for implementing and maintaining quality assurance and quality control systems with written SOPs to ensure that trials are conducted and data are generated, documented (recorded),and reported in compliance with the protocol, GCP, and the applicable regulatory requirement(s)
 Drug Research Centre is one of the pioneers in the filed of bioequivalence studies, bioavailability studies and Biowaiver studies
 
At Drug Research Centre, we strive to offer Top Quality and efficient services with the most competitive price for our clients.
 
Our goals are implementing quality management and Quality objectives meet exceed our customers' requirements and expectations to achieve customer satisfaction regarding high quality studies results complying with international standards, regulatory requirements and MOH- Egypt requirements.
 
Ensuring of implementing the safety and quality measure for all the center staff and customer.
 
Ensuring of implementing Good laboratory practice.
 
Drug Research Centre staff is familiarizing them selves with the quality documentation and implements the procedure in their work.
 
 

Quality Assurance Unit  of  DRC Policy considers the needed requirements for Bioequivalent centre and applied more strict rules to ensure & grantee that:

 

1- Control Files /Control Records of  Drug Research Centre are accurately and precisely adhere to DRC quality system.

 

 

2- Each equipment has its updated SOPs, Device Logbook, Calibration Label / DRC Calibration Label /Calibration Certificate.

 

3- Application , Activation & adherence to all DRC Approved SOP(s).

 

4- Internal audit plan specified for DRC with guidance checklist.

 

5- Adherence to training plan as DRC is concerned with training his staff upon hiring to develop their abilities to be matched with the work needs and loads at the centre.

 

6- Adherence to qualification system & perform of all needed calibration activities for the centre equipment through a certified calibration agency in time, according to calibration plan.