To start new unit

Production
1

i would like to start liquid manufacturing unit (antacid and syrup). please guide me what are the rules for site layout and partition is required

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2

I have the same project in Algeria.

3

ISO14644 “Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up” should answer a lot of your questions

4

Dear Nandhakumar you can easily start liquid manufacturing plant it is not so costly in comparison to tablet capsules and injectable plant, you need a minimum about 1000 sq. yard area.

5

Dear Nandkumar,

You will have to consider following aspects from cGMP point of view,

  • Lay out (Men & material movement, Placement of mfg equipment & machines)
  • QC Laboratory set up
  • Utilities such as Purofoed water system, Air Handling system-HVAC, Compressed air, Vacuum etc.
  • Quality & GMP Documentation
  • Qualification & Validation of equipment, Machines, Utilities, Analytical instruments
  • SOPs & Manuals
  • Preventive maint. & Engineering aspects
  • Quality Mnagaement System
    Yoy may write back to me on my personal email ID [email protected]
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6

Depending on the facility, your site layout should clearly identify the processing area/clean room/ warehouse with differential pressure.