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DOCUMENTATION
➢ Quality Manual Development
➢ Policies & Directives
➢ Standard Operating Procedures (SOPs)
o Training
o QA
o QC
o Manufacturing
o Clinical
o Regulatory
o Facilities
o Equipment
➢ Master Production Batch Records
➢ Specifications
➢ Supplier / CDMO Quality Agreements
➢ Validation Protocols
o Process
o Equipment (Qualification)
o Facility Systems
o Computer
o Cleaning
o Sterility
➢ Employee Training Files
➢ Stability Protocols