In the Bioequivalence world, Quality is not an option. FRC has defined the quality framework for its activities through a quality manual (QM), quality policy and standard operating procedures (SOPs), these together form the quality management system (QMS) which covers planning, operation and effective controls within the different activities. FRC ‘s QMS is operated by the ‘plan-do-check-act’ principle of continuous improvement. It is intended to ensure that FRC services are in full compliance with ISO 9001:2015, local and international regulations (GCP, GDocP, GLP,) in addition to customer & regulatory requirements.
QA personnel are independent of the work and are not directly involved in study-related
activities. They are responsible for:
Verifying all activities (clinical, bioanalytical, pharmacokinetics, statistical and reporting) undertaken during the study.
Ensuring that the QMS is regularly reviewed, updated & followed.
Ensuring that the GCP & GLP guidelines, internal SOPs, study protocol and EDA regulatory requirements are followed.
Checking all the study data for reliability and traceability.
Planning and performing internal audits at regular and defined intervals and following up corrective actions, if any.
Verifying that the study report accurately and completely reflects the data of the study and the methods and procedures followed.