You are a Lead Auditor for a multinational pharmaceutical company that holds a marketing authorisation for product X, a moisture and temperature sensitive tablet product.
Your company wishes to contract the primary and secondary packaging and warehousing/distribution of product X to a company
in Ireland. This company has two subsidiaries, one of which holds a manufacturing licence for the packaging operations and one a wholesale licence.
The tablet must be packaged within a bottle with a desiccant plug in the bottle top. The bottle is placed in a carton along with a patient information leaflet. The product storage conditions are 2-8 °C
You have been tasked with auditing the facilities to determine suitability for packaging and storage/distribution.
Prepare an Audit Plan and Checklist for this audit. Describe the methodology that you would use during the audit. In your answer you must research the relevant standards/guidelines that apply, identify any preliminary information that is important, resource your audit team, identify critical areas, prepare and justify the design of the audit checklist
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