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)
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.