Distinction between “quality control” and “quality assurance”.

“Quality control”means the steps taken during the generation of a product or service to ensure product/service quality. For a clinical trial, “quality control” encompasses steps taken during the clinical trial (e.g., investigator supervision, sponsor monitoring, and any ongoing review by regulatory authorities) to ensure that the trial meets protocol and procedural requirements and is reproducible.

“Quality assurance” refers to a systematic process to determine whether the quality control system is working and effective. Most often, quality assurance in clinical trials is implemented by the sponsor through independent auditing of quality control activities and, where applicable, by regulatory authorities through inspection of quality control systems and activities. Quality assurance audits may be performed during the course of the clinical trial and/or upon trial completion.


“The purpose of a sponsor’s audit, which is independent of and separate from routine monitoring or quality control functions, should be to evaluate trial conduct and compliance with the protocol, SOPs, GCP,
and the applicable regulatory requirements.”