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Engineering Documents Required in Pharmaceutical Industry

Engineering Documentation in Pharmaceutical Industry
  1. Heat Load Calculations.
  2. AHU Zoning drawing with pressure differentials.
  3. Airflow diagram.
  4. Ducting layout.
  5. Piping Layout.
  6. HEPA Box G.A.
  7. Man Movements layout
  8. Material Movements layout
  9. The layout of Pressure difference and area classification in production
  10. Area Qualification
  11. Area Mapping
  12. Commissioning Report of HVAC System
  13. Airflow & ACPH (Room wise)
  14. Filter Integrity (PAO) for All AHU
  15. Non-Viable Particle Count for All AHU
  16. HEPA filter Certificate
  17. Recovery Study Report (Room wise)
  18. Filter Certificates (HEPA, 05 microns & 10 Micron)
  19. Purchase Order
  20. Plant Layout Floor wise (Production)
  21. Plant Layout Floor wise (Warehouse)
  22. Plant Layout (General)

Water System
  1. Purchase Order
  2. MOC Certificate of Water Distribution Line and Purified Water Plant
  3. Welding Certificate of Joint
  4. Baroscopic Photo of Pipeline
  5. Dead Leg Certificates of sampling point and pipework
  6. DQ, IQ and OQ Protocol
  7. Schematic Diagram of water System showing all equipment in the system from the inlet to the points of use along with sampling points
  8. Approved piping drawings (e.g. orthographic and/or isometric)
  9. Commissioning Report of water System
  10. Calibration Certificate of All instruments used in water System – ( like – Pressure Gauge, Flow meter, Temperature Sensor)
  11. Slopes certificates of Pipeline

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