PreAudit

10

^/19

Onsite audit agenda & GAP review

Pharmaceutical, cosmetics, medical devices, dietary supplements, biotechnology

A typical audit agenda for an onsite audit, covering the company, its sites, its history and its documentation.

Visuals

Scope of work

Opening presentations by the auditees (company structure and background)

Site tours (manufacturing, laboratories, warehousing facilities)

Review of previous audit observations, including regulatory history

Interviews with SMEs for various functions

Review of training programmes

Documentation reviews (Deviation / CAPA, change controls, complaints, etc.)