MONITORING REVIEW AND AUDIT

The review is a higher level managerial activity designed to see if the HSE programmes that have been put in place are achieving the desired objectives. If the answer is no then the review seeks to find out why this is the case. The objectives may 

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Monitoring, auditing and reviewing fire safety systems... 

An additional QA unit monitors LIMS activities as described in the GALP guidelines. The QA unit s responsibilities primarily are inspection, audit, and review of the LIMS and its data. An organizational plan is developed to define lines of communication, reporting, inspection, and review of the LIMS and its data. The QA unit must be entirely separate from and independent of the personnel engaged in the direction and conduct of a study and should report to laboratory management. 

Monitoring audit, and comparison Were adequate provisions made to evaluate the safety program and the safety program review effort Were meaningful comparisons with similar organizations or operations included ... 

Perform audits and reviews to monitor the effectiveness of the company s SHE management system. 

The appropriate corrective actions should be identified and implemented as a result of the monitoring and review of safety performance. Arrangements should be in place to ensure that appropriate corrective actions in response to audit and review findings are identified and taken. Progress in taking proposed actions needs to be monitored to ensure that actions are completed within the appropriate time-scales. The completed corrective actions should be reviewed to assess whether they have adequately addressed the issues identified in the audits and reviews. 

Procedures should be established to periodically monitor all operations that may have an environmental impact, and similar scheduled periodic checks should be made to ensure that procedures and operations are still in line with regulatory and other requirements. If equipment is involved in the monitoring process then procedures should also be in place to ensure correct calibration. Procedures are also needed to record any preventative or corrective actions identified and to ensure that they are completed to schedule. The whole EMS should be audited periodically to check that it is consistent with the planned policy and has been properly implemented. The details of audits should be discussed and reviewed by management at the highest level with a view to continuous improvement through the modification of both policy and procedures. 

Two important aspects are internal audits and product quality review. Internal audits are implemented to regularly monitor the compliance activities in drug manufacture and to ensure rectification to these activities if deviations occur. Trending and statistical analysis of data provide early warning of impending problems. Product quality review checks the relevance and adequacy of the manufacturing activities. It provides input to update and improve the quality system. 

Quality Assurance is the system of monitoring, inspecting, and auditing which assures that the work is documented and conducted according to protocol and the laboratories standard operating procedures from the conception of a study to the review of the final report. 

The necessary components of a complete QA/QC program include internal QC criteria that demonstrate acceptable levels of performance, as determined by a QA review (audit). External review of data and procedures is accomplished by the monitoring activities of accreditation organizations such as the Standards Council of Canada (SCC, 2005). This includes laboratory evaluation samples (PT samples, see above) and a periodic (sometimes every 2 years) on-site assessment of all QA/ QC procedures, performed by external assessors from the accrediting organization. 

GxP data, records, and documentation including computer vahdation should be archived. Internal audit reports from self-inspections monitoring a pharmaceutical or healthcare company s compliance with its own quality management system do not have to be retained once corrective actions have been completed, so long as evidence of those corrective actions is kept (e.g., change control records). Supplier audit reports and periodic reviews are not internal audits and should be retained. 

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