Auditor regulators

The GLP principles are a managerial concept defining the organizational processes and conditions under which laboratory and field research is planned, performed, monitored, recorded, and reported. They were designed to ensure that sampling and analytical procedures and results are complete and of known, documented quality. When a study is GLP compliant, an auditor, regulator, or analyst should be able to review the smdy some years after its completion and easily determine what work was done, when, where, by whom, and with what equipment and methods who supervised the study what results were obtained and whether there were any problems encountered and, if so, how they were handled. Considerable effort and dedication in planning, support, and implementation is required to achieve this standard of documentation and attention to detail. Successful implementation of GLP provides reliable data for which the precision, accuracy, comparability, and completeness is known. 

This example shows cradle-to-grave documentation for each SIF. This documentation pedigree gives auditors and plant personnel the means to track the SIF through the safety lifecycle phases back to the process hazards analysis (PHA) that created it. Each SIF is clearly identified in each document to facilitate tracking between lifecycle phases. A vital part of safety is the ability to demonstrate to others (e.g., auditors, regulators, insurance companies) that the risk reduction provided by each SIF is adequate. 

On completion of an audit and before the auditors leave the premises, the management of the site will be briefed as regards the main observations during the audit. Where issues arise, FDA inspectors use Form 483 to present the manufacturer with a list items that may be deemed as non-compliant with the regulations. Should any non-conformances be highlighted at the audit close-out session, management should state their commitment to correcting these and, if possible, indicate what the... 

Because of the complexity of computer hardware and software and because of the intricacy of a risk assessment, the FDA has to all intents and purposes adopted an indirect regulatory posture. Regulated companies are informally urged to conduct independent audits of Part 11 compliance, utilizing in-house or consultant expertise. The agency can then review the details of the audit report and the credentials for experience, expertise, and independence of the auditor. Follow-up investigation of speciflc points can then be laser-focused on specific areas of concern. 

The audit also emphasizes the self-regulated nature of the industry and the ideal relationship between the agency and the industry. In theory and effective practice, a biomedical company utilizes its quality assurance (QA) unit (in this case, supplemented by credible Part 11 auditors) to maintain control of safety, effectiveness, and quality. The FDA can then review the quality system (QS) and spot-check the other systems such as laboratory or production for most efficient regulatory oversight. In effect, the QA regulates the company and the FDA regulates the QA. 

The goal of a quality assessor or auditor is to ensure that the organization succeeds by focusing on quality and not necessarily compliance. Full compliance with applicable regulations is certainly desirable if an organization is committed to forward quality, continuous improvement, and global competitiveness. 

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