Good Manufacturing Training

1. SMIT PATEL
Quality Executive (GMP)
Himalya
International ltd.

2. 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.

3.  Personnel Hygiene
 Physical facilities
 Storage practices
 Sanitation
 Process equipment
 Housekeeping
 Pest control
 Documentation

4. • 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.

5.  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

6.  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

7.  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

8.  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.

9.  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.

10.  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

11.  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

12.  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

13.  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

14. • 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

15. • 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.

16.  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

17. 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

18.  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.

19.  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

20.  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.