GCP stands for Good Clinical Practices in the pharmaceuticals industry.
GCP Trials (Good Clinical Practices) are ethical and scientific standards for designing, recording, and reporting human research trials.
A good clinical practice (GCP) standard ensures that studies are scientifically valid and that clinical properties of investigational products are accurately documented.
In a clinical trial, GCP guidelines include human rights protection for subjects and volunteers.
Public trust in clinical-trial data is enhanced by adherence to this standard, which ensures that trial subjects’ rights, safety, and wellbeing are protected. As well as providing assurance of safety and efficacy, it also assists in the development of new compounds.
The following organizations may be required to comply with GCP:
- Pharmaceutical Industry
- Contract Research Organizations (CRO)
- GP Practices
- NHS Hospitals
- Analytical Laboratories
Guidelines for good clinical practice have been developed by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
Only one regulatory agency-produced guide on Good Clinical Practice is available within Europe.
To overcome from the GCP inconsistencies from all over the world the ICH issued the guidelines: Topic E6 guidelines for GCP.
Importance of GCP:
Reason for introduction of GCP trial guidelines is;
- It Increased the ethical awareness
- Improved trial methods
- Better understood the clinical trial concept
- Frauds and accidents during trials
- Public/political concern over the safety aspects
- Growing research and development costs
- Increasing competition
- To Understood New market structure
- Mutual recognition of data
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Refer YT Channel: Pharmabeejpro