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Plant Approval

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Plant Approval

The manufacturer of medical devices shall note that the first and foremost step in the process for obtaining a manufacturing license is to prepare plant layout. The manufacturer shall comply with the requirements laid out in Indian Medical Device Rule 2017.
Manufacturers of medical devices like orthopedic implants, disposables and other medical devices, primary packing material have to design their manufacturing unit to meet cGMP requirements& other regulatory requirements.

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When it comes to the correct designing of the facility, the man and material movement is an important factor to be taken into consideration. Raw material and product segregation, the manufacturing flow, process steps, the classified areas play critical role. The plant layout is prepared by AUTOCAD experts based on the inputs from client and Maven experts. We also consult manufacturers for expansion of existing facility or changes in design of the existing facility

The Plant Layout is to be submitted to CDSCO as a part of test license application as well as manufacturing license application.

The plant layout shall contain or shall depict the following:

  • Site plant Layout which shall include equipment layout, men & material flow lay out, pressure differential lay out
  • HVAC schematics and details of areas Where in clearly specify the filtration level & classification of core areas & rooms
  • Schematic diagrams of water system –along with the components

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