Engineering Documentation in Pharmaceutical Industry

Engineering Documentation in Pharmaceutical Industry

  • Heat Load Calculations.
  • AHU Zoning drawing with pressure differentials.
  • Airflow diagram.
  • Ducting layout.
  • Piping Layout.
  • Hepa Box G.A.
  • Man Movements layout
  • Material Movements layout
  • The layout of Pressure difference and area classification in production
  • Area Qualification
  • Area Mapping
  • Commissioning Report of HVAC System
  • Airflow & ACPH (Room wise)
  • Filter Integrity (PAO) for All AHU
  • Non-Viable Particle Count for All AHU
  • HEPA filter Certificate
  • Recovery Study Report (Room wise)
  • Filter Certificates (HEPA, 05 microns & 10 Micron)
  • Purchase Order
  • Plant Layout Floorwise (Production)
  • Plant Layout Floorwise (Warehouse)
  • Plant Layout (General)

Water System

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

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