Good clinical practice (GCP) and good laboratory practice (GLP) are quality standards that ensure the safety, reliability, and integrity of clinical trials and laboratory studies. GCP and GLP monitoring and audit are essential activities to verify compliance with these standards and identify any gaps or issues that need improvement.
Regular visits to study sites or laboratories by qualified monitors/auditors are necessary for monitoring and auditing. During these visits, the monitors/auditors review study documents, protocols, procedures, data, and records. They also verify that study staff and laboratory personnel are adequately trained, qualified, and competent to perform their tasks. In addition, the monitors/auditors provide guidance and feedback to improve performance and adherence to meet agency expectations. GCP and GLP audits can be conducted by internal or external parties, including sponsors, contract research organizations (CROs), regulatory authorities, or independent auditors.
When a pharmaceutical company decides to outsource some of its activities to a contract research organization (CRO) or a contract manufacturing organization (CMO), it is crucial to ensure that they meet regulatory requirements. One of the best ways to do that is to conduct a CRO audit, which is a systematic and independent examination of their facilities, systems, processes, and documentation. A CRO audit can help to identify potential risks, gaps, and areas for improvement, as well as verify the competence and compliance of a CRO partner.
GCP and GLP monitoring and audit involve reviewing various aspects of the trial or study, such as:
- Monitor the adherence to study protocol and regulations
- Study personnel qualifications and training
- Informed consent process and documentation
- Recruitment and retention of participants (clinical and non-clinical studies)
- Randomization and blinding procedures
- Data collection, management, and analysis methods
- Handling of Serious adverse events, its reporting and management
- Investigational Product (IP)/ Sample storage and handling
- Equipment calibration and maintenance
- Review of raw data, logbooks, chromatograms, and annotations
- Handling of deviations and CAPA management
- Record keeping and archival.
The regulatory audits are an essential requirement and a valuable opportunity for CROs and Pharmaceutical organizations to demonstrate their commitment to quality and excellence in clinical research.
Freyr has an expert team of auditors who could support the sponsors in conducting GCP/GLP audits and monitoring. Customized solutions to meet your needs are provided.
