I will create, write, proofread, copywrite your Technical Documentation for current GMP requirements
- Operation Manual
- Instructions
- Temperature mapping
- Audit reports / Inspection reports
- CAPAS
- Complaints Reports
- Risk assesment
- Production Report
- Distribution
- Deviations Reports
- Change control Reports
- Qualification
- Protocols IQ, OQ, PQ, URS
- Reports
- Validation Master Plan
According international guidance that you need
WHO, FDA, EMA, ISO, IRAM, PICs, ICH, others