Health audit principles

Inspections for compliance with GLP Principles may take place in any test facility generating health or environmental safety data for regulatory purposes. Inspectors may be required to audit data relating to the physical, chemical, toxicological or ecotoxicological properties of a substance or preparation. In some cases. Inspectors may need assistance from experts in particular disciplines. 

Any facility that produces data in support of these non-clinical studies is required to con ly with the principles of GLP and will be audited for compliance by the appropriate regulatory authority. In the case of the UK this would be the United Kingdom GLP Compliance Monitoring Authority, which is part of the Department of Health. In the USA this would be the appropriate FDA department. 

The purpose of an audit is to ensure compliance with standards and to challenge existing policies, procedures, and practices and their underlying concepts and principles. An audit can look at leadership, compliance with policy, rules and standards, and the effectiveness of safety and health procedures. It may uncover opportunities to improve in the future. Auditors must handle their visit cautiously. They are not trying to place blame or ridicule people in the department or business unit. 

Risks may be identified through employee identification of them, safely inspections, analysis or accident statistics, and near miss incident audits, checklists and reports. This is not an exhaustive list, however. Once risks are identified, review the process involved from Step 1, within the selected department (Step 2), then evaluate and apply risk control principles in consultation with the department supervisor, employees and health and safety representatives (where they exist). 

There are a number of ways in which this can be achieved and some parts of the system do not need auditing as often as others. For example, an audit to verify the implementation of risk control systems would be made more frequently than a more overall audit of the capability of the organization or of the management arrangements for health and safety. Critical risk control systems, which control the principle hazards of the... 

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