Schedule M · 21 CFR 211

OSD documents

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Microbiology

EM, water, sterility, MLT, media, disinfectant validation1 documents

QC

Analytical methods, instruments, stability, OOS0 documents

QA

QMS, deviations, CAPA, change control, audits, APQR1 documents

Production

Manufacturing, line clearance, BMR, cleaning0 documents

Engineering

Utilities, HVAC, water system, preventive maintenance0 documents

Warehouse

Receipt, storage, dispensing, FIFO/FEFO0 documents

Regulatory

Dossiers, licences, regulatory submissions0 documents

EHS

Safety, environment, waste management0 documents

All departments Microbiology QC QA Production Engineering Warehouse Regulatory EHS

All types SOP Validation Qualification Calibration Site Master File Training Format / Log CAPA Root Cause Analysis (RCA)Deviation / Investigation Risk Assessment Change Control Regulatory Document Audit Checklist / Report Gap Assessment APQR / PQR Data Integrity

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