Free download
Pharma plant setup checklist (PDF)
Everything to plan for a new pharma plant or production line: building, clean rooms, utilities, machines, validation, licences and people.
What is inside
- 1. Product & capacity plan3 points, e.g. list each dosage form (tablets, capsules, liquids, ointments, injectables…) and target output per shift
- 2. Site & building4 points, e.g. land / shed in an approved industrial area with the right zoning
- 3. Clean rooms & HVAC4 points, e.g. area classification for each room (e.g. grade d / iso 8 for oral solids; higher for sterile)
- 4. Utilities4 points, e.g. purified water system (and wfi for injectables) with storage and loop
- 5. Machines (example: oral solid dosage)6 points, e.g. weighing and dispensing: balances, dispensing booth
- 6. Documentation & validation4 points, e.g. urs for every machine, then dq, iq, oq and pq
- 7. Licences & approvals (check current rules)4 points, e.g. company registration, gst and udyam (msme) registration
- 8. People & training3 points, e.g. qualified production head, qa and qc heads as required by the licence
- 9. Timeline & budget4 points, e.g. building and clean rooms: plan several months before machine delivery