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. For more information on Compliance Auditing check on this: https://en.wikipedia.org/wiki/Audit
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