Quality control (QC) – is set of techniques and procedures implemented to ensure that the data collected during the trial is accurate, consistent, and reliable. Quality control is a subset of Quality assurance (QA) and aims to maintain the overall quality of the trial data and the validity of the study results.
QC aims to identify and correct issues to maintain data integrity and validity.
Definitions
ICH E6(R2)
- 1.47 Quality Control (QC):
- The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial-related activities have been fulfilled [1].
ICH Q7
- Quality Control (QC):
- Checking or testing that specifications are met [2].
ISO 9000:2015 Quality management systems
- 3.3.7 quality control:
- part of quality management (3.3.4) focused on fulfilling quality requirements (3.6.5) [3].
Goal of quality control
Quality control measures are implemented to identify and correct any errors, inconsistencies, or deviations from the study protocol, as well as to prevent such errors.
See also
Another relevant pages
Links to this page
References
- ↑ ICH, 2016, Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2), https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf Accessed Sep 2023
- ↑ ICH, 2000, Harmonised tripartite guideline Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients https://database.ich.org/sites/default/files/Q7 Guideline.pdf Accessed May 2024
- ↑ ISO, 2015, ISO 9000:2015 Quality management systems – Fundamentals and vocabulary, https://www.iso.org/obp/ui#iso:std:iso:9000:ed-4:v1:en:term:3.3.7 Accessed May 2024
External links