In the pharmaceutical development, when a sponsor audits an external organization that has been contracted to clinically develop a pharmaceutical, the sponsor may have difficulty conducting the audit with their own resources given their lack of expertise in the contracted work. In the same vein, having an external organization undergo similar audits by multiple sponsors would presumably be inefficient. Thus, the current authors planned a “group audit” conducted jointly by multiple sponsors audited by the form entrusted an external organization, and the authors examined the usefulness of and issues with a group audit.
To select companies to undergo a group audit, authors conducted a questionnaire survey on Corporate members of the GCP Division of the Japan Society of Quality Assurance. Based on the results of the questionnaire survey, authors selected one laboratory testing company and one system vendor were obtained an agreement on acceptance of the group audit. This group audit involved a total of 22 companies. After the group audit, companies involved in the audit and companies being audited were surveyed, and assessments of the group audit and its advantages and disadvantages were examined. The main reasons why companies wanted to be involved in the group audit were because of “a lack of expertise in the area being audited” , “a lack of internal resources” , and “to reduce costs”.
The group audit received a more favorable rating overall than an individual audit, and respondents were highly satisfied with its “cost, effort, and quality” in particular. That said, the overall time taken for the audit was cited as one of its disadvantages.
Companies being audited rated the group audit as “no different from an individual audit”, and they considered “a group audit more acceptable”. These findings suggest that a group audit is a useful auditing approach, and this approach should increase the overall efficiency of auditing.
