SMIT PATELQuality Executive (GMP)Himalya International ltd.
Good Manufacturing Practices are the basic controlmeasures and procedures that have to be carriedout to produce a product which meetsspecifications 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.