SMIT PATEL

Quality Executive (GMP)

Himalya
International ltd.
Good Manufacturing Practices are the basic control
measures and procedures that have to be carried
out to produce a product which meets
specifications and is safe to consume.
 Personnel Hygiene
 Physical facilities
 Storage practices
 Sanitation
 Process equipment
 Housekeeping
 Pest control
 Documentation
• Hi level of personal cleanliness while in
the production facility
• Everyone must wash and sanitize their
hands before entering to process.
• Use hairnets
• Wear washed uniforms
• Do not enter without safety shoes
• All visitors must wear white cleaned Lab
coats.
 No outer pockets should be provided in uniforms
 Do not take any food, tea or coffee inside the
process
 People should carry only the metal pen without
cap inside the process
 Smoking is not allowed anywhere inside the
factory.
 Chewing gum, tobacco or any other mouth
freshener is not allowed in process area
 No jewelry and watches while in the
process .
 Finger nails should be short, clean and
without polish
 No body odors, including the use of strong
perfumes
 Personnel, having any disease, boils, sores,
infections must not work within direct
contact of raw materials or finished product
 Any operator, who comes in direct manual
contact with raw materials or products,
must wear disposable gloves
 Regular Medical Checkups for all the
medical Non – Compliances
 No access to rodents, birds or insects
 Smooth walls and ceiling
 Easily cleanable floors and drains
 Sloping surfaces
 Externals clean and free of debris
 Doors to be self closing and without gaps
 Windows to be closed and have screens
 There should not be any visible cracks in
walls, floors etc.
 Separate change room and eating areas
 Ceiling, walls, overhead pipes &
equipment in general must be clean and
free of peeling paint, rust, adhering
debris, structural damage, dust or other
contaminations
 All plumbing and effluent lines as well as
ventilation or exhaust system must be
clean and properly maintained
 Manufacturing and warehousing facilities
must be structurally separated from each
other and access must be controlled
 Lighting levels in all the areas of plant
must be of at least 500 lux at work level.
 Ingredients & raw materials to be
inspected before use
 Trailers / Containers / Trucks to
be inspected for contamination on
arrival
 No materials should be stored on
floor
 Opened containers must be
covered when not in use
 All material to be labeled
-material name, mfg date, batch
no. & expiry date
 Store material 18’’ away from
wall.
 All weighing and any other measuring devices must be properly
maintained and calibrated.
 There should not be any glass material in the storage
 Stacking height of containers must not exceed the safety load,
no deformation of stocking units
 If contamination is suspected or the package of raw and
packaging materials delivered in poor condition, the lot should
be separated and returned
 Continuous Temperature Monitoring Device
should be applied to any critical storage area,
like cold storage
 Plant must have a separate and clearly
identified area for questionable or rejected raw
materials and products
 Rejected goods must be disposed off at regular
frequencies and record of rejection and disposal
must be kept
 Material of construction to be stainless steel
 No equipments should be contaminated with any dirt, grease
 Supply of clean air for running any pneumatic equipments
 Equipments should be easy to clean and accessible
 Tagging of Equipments
 Rubber / plastic parts – to food grade standards
 Calibrated thermometers and pressure gauges
 No loose live electrical cables anywhere in the process
 Maintenance technician should
check and clean the area after
completion of work so that any
tools, wires, taps, welding rods are
not left
 CIP after maintenance
 No Leakages
 Any loose nut bolt or any other
m/c part should be fixed up
immediately after brought into
notice
 There should not be any temporary
fixation of any machinery part with
BOPP adhesive tape
• Floor should remain dry
• All drains should be
thoroughly cleaned
• No foul smell from drains
• No product & oil spillage
on floor
• Spilled oil in any case
should be cleaned with
immediate effect.
• No chemicals to be stored
inside the plant.
• Ensure cleaning
equipments are kept in the
designated area
• No unwanted materials, equipments in the
process area
• Cleaning hoses should be rolled properly and
put in place
• Ensure all materials are retuned to store
after processing is over.
• There should not be cob webs any where in
the production facility
• Waste materials are disposed off at regular
intervals, waste bins should not be
overflowing.
 Cleaning of equipment by either dry / or wet method
 Dry cleaning means collection, removal and disposal of dust
 Compressed air not recommended for cleaning
 Avoid wet cleaning in dry cleaning area
 Wet cleaning designed according to equipment
 Protect electrical cable and control panel during wet cleaning
 Cleaning must precede disinfection
 Personal safety is important
 Visual inspection after cleaning
 Cleaning efficiency check
 Drains to be cleaned regularly disinfected
 Pest is a group of animals or insects which may
be harmful to human beings or food products.

 Plant should be free form any kind of pest and

insects like house fly, cockroaches, spider, moths,
cricket, weevils, grasshopper, ants etc.
 There should not be any rodents, lizards, birds,
cats inside the production facility.
 A complete pest control program should be inside
the plant.
 People should notify immediately in case any
trace of infestation is visible inside the plant
 Basic philosophy of pest control program is to
deny entry, deny food and deny shelter to any
pest, flying insects, rodents, birds.
 Do not keep open any doors and shutters open for
their entry.
 Do not keep any food material open in the process
which can attract all these pest.
 Do not keep any area dirty with unnecessary
things which can harbour rodents and pests.
 There should not be any chemical bait stations for
rodents in the process, packaging, Dry store and
receiving area.
 Only Mechanical bait stations are to be placed in
these areas.
 Standard operation procedures
 Manufacturing instruction sheet
 Batch production record
 Lot traceability
 All laboratory / production data to be legible
 All mistakes to be crossed out leaving original figures
visible
 Record of consumer complaints & follow up action
 A batching sheet must be available for every
production process performed within the plant,
showing all the details
 Documentation of all testing and inspection must be
maintained
 Sample must be kept for periods not shorter than the
expected shelf life
 All procedure ( Manufacturing, Hygiene, Safety,
Packaging, Storage, Services etc.) must be
documented
 All record must be kept in an easily readable manner
with it’s access restricted to persons who need to
know.