GMP Facilities Set Up

Powder Mixing Facility

Reference For FNB-SME
 GMP component
• Equipment qualification
• Process validation
• Regularly schedule preventative maintenance
• Regularly process review and revalidation
• Relevant written standard operating procedures
• The use of competent technically qualified personnel
• Adequate provision for training of personnel
• A well defined technology transfer system
• Validated cleaning procedures
• An orderly arrangement of equipment (flow of
material/prevent cross-contamination)
 Basic principle of GMP areas
• Separated areas for separate function
– Receiving and shipping
– Storage
– Packaging and printed material
– Weighing
– Production
– Anciliary areas
 Receiving
• Cleaning of incoming container
• Material receipt
– Material name,batch
no,supplier,MSDS/COA/HALAL,quantity,date
 Storage
• Sufficient capacity
• Order manner (according category)
– Starting material
– Packaging material
– Intermediates
– Bulk
– Finished products
– Quarantine
– Released
– Rejected
– Returned
– Recalled
 Packaging
• Critical: ensuring correct labeling of product
• Sampling
• Storage
• Specification (avoiding mixing up)
 Weighing
• In separated areas
• Appropriate design (training material on
HVAC)
• Dust control
• Cleaning procedures and records
• Documentation
 Production *clean area
• Layout in sequence and avoid cross
contamination
• Cleanliness level
• Work in process storage space
• Positioning of equipments
• Environmental control
– Ventilation, air filtration system
– Control of RH and temperature
 GMP
• Walls, floors and ceiling surfaces
• Temperature and humidity control
• Air supply filtered through HEPA filters under
positive pressure
• Environmental monitoring program
• Cleaning and disinfecting program
• Equipment maintenance program
 Key Element in GMP
• Processing area
• Protect product from contamination
 Key Design Issues
• Vessel mixing (agitator design)
• Sanitary piping design
• CIP circuit design
• Temperature control
• Equipment design
• Process control (interlocks)
• Equipment arrangement (facility layout)
Space requirements

Administration
Physical testing
and information
area
processing

Standard
equipment floor Storage area
processing
 Process evaluation
• Order if mixing of components
• Mixing speed
• Mixing time
• Rate of addition of granulating agents, solvents,
solution etc
• Heating and cooling rates
• Filters size
• Screen size
• Drying temperature
• Drying time
 Manufacturing procedures
• Weight sheet
• Processing direction
• Manufacturing procedure
 Weight Sheet
• Identify chemical needed by batch
– Names
– Amount
• Manufacturing procedure (written by
operator)
• Specification in SOP should be mentioned
– Addition rates, mixing times, mixing speed,
heating, cooling rates, temperature, storing of
finished product samples.
 Product stability and uniformity
• Physical and chemical stability of products.
• Each pilot batch
– Final formulation
– Manufacturing procedure should be studied for
stability
– Stability studies (should be carried out of it
finished packaging)
 Reference
• https://www.slideshare.net/madhmad/pda-
facility-design
• https://www.slideshare.net/boreddysunilkum
arreddy/pilot-plant-scaleup-techniques-used-
in-pharmaceutical-manufacturing
• http://dairyprocessinghandbook.com/chapter
/whey-processing