Simple guideline for Pharmaceutical Manufacturer for Production Area

 

  • Ensure uniflow direction (starting from Entry to Exit) for Men, Raw Materials and Finished Goods.

  • Toilet and Canteen should be completely separated / segregated from Production area / space.

  • Appropriate measure should be taken for avoiding Cross Contamination during manufacturing / production. This can be ensured by creating sufficient Air Pressure Difference in AHU area and using leak proof doors.

  • Ensure cleanliness by using proper, efficient and quality Air Filters (as per specification / Standard) with AHU / Air Handling System, Laminar Air Flow Bench / Station.

  • Follow the simple protocol of Clean Room usage (by restricting entry, by using separate Clean Room Dress / Shoes / Chappals / Shoe’s cover etc.).

  • Follow strictly washing / cleaning protocol of manufacturing containers and filling bottles with clean DM water.

  • Ensure quality check / testing of products during stages of manufacturing.

  • Maintain strictly transparent and simple protocol / method in all activities of production as per GMP / ISO standard and maintain record and sample regularly and systematically.

  • While designing your required Air Handling System (Clean Room / Zone System), please check and ensure :-

    whether your designed system is correct or appropriate for your products / activity of production.

    whether quality of Blower, Motor, Compressor, Condenser will require minimum energy load (electrical power consumption) - this will give you high cost saving in long run.

    Whether the technical parameters of the system is supported by testing / validation.

     

  • Plan to validate and calibrate your system and equipment on regular basis as per GMP standard / specification.