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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

About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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