Compliance Auditing

You have been requested to audit the following area within your biologics manufacturing facility.  You manufacture EPO bulk drug substance (stored at -20 deg C) and formulated and filled as vialled finished product (stored at 2-8 deg C).  The checklists and documents requested should focus on routine checks but especially on high risk areas specifically associated with the area allocated and legislative requirements. Outline and submit as a word document:  1/. The specific documents that you would request in advance and 2/. The specific checklist that you would prepare for each audit and 3/. Include a list of references used to complete this assignment. Checklist areas: Validation of Isolation and Purification steps