GCP Audits - Clinical Trials for Drug and Medical Device
The independent third-party GCP audit service provided by BBC is to evaluate GCP compliance status of the manufacturer in accordance with the current GCP requirements and ICH GCP guidelines. The compliance status will be evaluated in terms of clinical trial facilities, document control, monitoring activities, and personnel. All deficiencies identified during the GCP audits will be noted in the audit report with gap analysis and proposed corrective actions.
The GCP audits will be conducted by two BBC auditors for three days. A GCP audit report of Chinese or English version or of both Chinese and English version will be provided.
Remedial actions should be taken to rectify these deficiencies indicated in BBC抯 GCP audit report. You can formulate your own remedial action plan or retain BBC as GCP consultant to assist you in the project to improve your GCP compliance status.
GLP Audits - Pre-clinical Studies for Drug and Medical Device
The independent third-party GLP audit service provided by BBC is to evaluate GLP compliance status of the manufacturer in accordance with the current GLP requirements set forth in 21 CFR Part 58 with its interpretations. The compliance status will be evaluated in terms of facilities, document control, quality control, and personnel. All deficiencies identified during the GLP audits will be noted in the audit report with gap analysis and proposed corrective actions.
The GLP audits will be conducted by two BBC auditors for three days. A GLP audit report of Chinese or English version or of both Chinese and English version will be provided.
Remedial actions should be taken to rectify these deficiencies indicated in BBC抯 GLP audit report. You can formulate your own remedial action plan or retain BBC as GLP consultant to assist you in the project to improve your GLP compliance status.