2. Locations and Surroundings
The factory building (s) for manufacture of
drugs shall be so situated and shall have such
measures as to avoid risk of contamination
from external environment including open
sewage, drain, public lavatory or any factory
which produces disagreeable fumes, excessive
shoot, dust, smoke, chemical or biological
emissions
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3. Location
► Premises must be
located to minimize
risks of cross-
contamination; e.g. not
located next to a
factory with high
airborne levels of fungi
and yeast
► Photograph shows a
liquid oral
manufacturing unit
situated close to a
factory producing Malt
preparations
► This has caused high
degree of microbial
contamination
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4. Formulation factories may not be located
wherever the land or plot is available
►Geography – Free from geographical
disturbances such as earthquakes
►Climate – Free from disturbances such
as floods
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5. Adequately provided with working
space to allow orderly and logical
placement of equipments, materials,
and movement of personnel so as to:
►avoid the risk of mix-up between
different categories of drugs or with RM,
intermediates and in-process materials.
►avoid the possibilities of contamination
and cross contamination by providing
suitable mechanism
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6. ►Designed / constructed / maintained to
prevent entry of insects, pests, birds,
vermin & rodents.
►Interior surfaces (walls, floors and
ceilings) shall be smooth and free from
cracks and permit easy cleaning,
painting and disinfection
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7. ► Airconditioned, wherever prescribed for the
operations and dosage forms under
production.
► The production and dispensing areas shall
be
well lighted,
effectively ventilated with air control facilities
may have proper Air Handling Units (wherever
applicable) to maintain conditions including
►temperature and wherever necessary humidity as
defined for relevant product.
► These conditions shall be appropriate to the
category of drugs and nature of operations.
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8. ► The walls and floors of the areas where
manufacture of drugs is carried out shall be
free from cracks and open joints to avoid
accumulation of dust.
These shall be
►smooth
►washable
►coved and
►shall permit easy and effective cleaning and
disinfection.
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9. ► These shall also be suitable to the comforts
of the personnel working with
protective clothing,
products handled,
operations undertaken within them in relation to
the external environment
► Theseareas shall be regularly monitored for
compliance with the required specifications.
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10. Other Areas
► Personnel rest areas/cafeterias/changing
rooms
away from operating areas
prevention of cross-contamination
prevention of operators going outside in work
clothes
provision of access control
prevention of visitors access to operating areas
► Maintenance service areas
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11. Finish of Floors, Walls and Ceilings
► Difficult but not impossible to get correct
surfaces
► Smooth, impervious, hard-wearing, easy to
clean
► Resistant to operations and materials in use
► Windows not opening to the outside
► Avoid sliding doors
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12. ►A much better Finish of Floors, Walls
and Ceilings could look like this. The
surfaces are epoxy painted and interior
surfaces are made smooth
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13. Design Principles for logical work
flow should be considered with
following aspects
► Process flow
► Material flow
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14. Design Principles for logical work
flow should be considered with following aspects Material flow
People flow
QC Offices Canteen
Gowning
Incoming
goods Shipping
Corridor
Corridor
Corridor
Raw
Materials Finished
Packaging
& Filling Products
Packaging Weighing Processing
Storage
Storage
Washing Machine
Shop
Corridor
Utilities and Services Waste Treatment
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15. Manufacturing and Packaging Areas
► Pipe-work and other fittings placed to avoid
recesses
► Drain design:
equipped to prevent backflow
open channels avoided
► Effective air handling to suit product
Temperature
Humidity
Air filtration
Environment monitoring
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16. Manufacturing and Packaging Areas
► Specifically designed and laid out to avoid
mix-ups and cross-contamination
Changing facilities to provide segregated
access
► Prevention of cross-contamination
► Suitable lighting levels
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17. In-Process and QC laboratories
► Located
separate from but near
manufacturing
prevention of cross-contamination
separate biological & microbiological areas
► Designed for the operations being carried
out
suitable storage space
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18. Design aspects - Tablets
► Lay out for Tablets could be
► Room for Weight checking, Sifting, Milling, Mixing, Granulation
► Room for Paste preparation
► Room for Drying – FBD and or Tray driers
► Room for Equipment Washing
► Room for maintenance of clean equipment
► Compression cubicles
► IPQC area
► Coating Area
Coating solution preparation
Sugar & Film coating operations, drying (if necessary) - a tray drier
► Inspectionarea
► Quarantine Area
► Packing Area Strip Blister or Bulk
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20. Design aspects -
Liquid Oral Preparations
► Sugar Syrup Preparation area
► Area for preparation of solids for suspension
► Compounding and filtration / Homogenization area
► Equipment washing area and area for maintaining
clean equipment
► Bottle washing area
► Filling area
► Labeling and packing area
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