Effective Audit management (Hosting Audits) in Pharmaceutical industry

The effective management of audits performed by external parties (customers or Third Party Auditors or, inspections by regulatory authorities or certification bodies) is vitally important. Therefore additional organisational issues for consideration are as follows:

- Properly review the audit agenda 

-Availability (and if necessary translations) of key documents

- Availability of key staff, and involvement of senior and/or top management (provide correct partner for discussions)

-Assembly of a ‘task force’ to co-ordinate preparations

 

- Composition, organisation and responsibilities of the host ‘team’

- Domestic arrangements (settings) such as office space with ambient temperature, communications, avoiding interruptions (e.g. telephone), etc.

-Training of staff in what to expect, and how to respond to an auditor’s questions

- Decide policy on accessibility to internal audit reports

-Identify restrictions (e.g. photographing, video taking, areas not assessable, etc.)