To achieve the objectives of GMP GHP

To achieve theobjectives, each manufacturer ensure that each step is properly followed with detailed procedures in place.

1.      Factory Location

·        Factory site must be at some distance from infection prone industries like animal farms, garbage dumps, slaughter houses etc.

·        Area should be free from smell, smoke, fly ash, dust.

2.      Layout and Building Design

      Define clearly

·        Process areas

·        Services areas

·        Traffic and access area

3.      PROCESS AREA

·        Physically separate process area for dry & wet ,low, medium & high hygiene levels

·        Ensure good ventilation, natural ,air conditioned , mechanical, humidity controlled etc.

·        Protect against insects, birds , rodents etc.

·        Avoid uncleanable spots in floors, walls , ceiling, &condensate drips from fixtures ducts &pipes.

·        Right design to facilitate maintenance of sanitary operations.

·        Sufficient lights with proper safety type fixtures

·        Proper slope of drains, floors, windows ledges etc.

·        Avoid false ceiling & walls

·        Minimize number of sewer in process area.

·        Use materials which are approved by legislation, lasting and cleanable.

·        No toilets in process area.

·        Plan layout keeping in mind proper flow of raw materials to finished products .No cross flow.

·        Entry points to ensure positive air pressure.

·        Enough space for orderly placement of equipment and materials

4.      PROCESSING EQUIPMENT

·        Right design for the specific product and surfaces coming in contact with the products shall not adversely affect the product and to be compatible with the product .Also easily accessible for cleaning .If in place cleaning system used .results to match manual cleaning.

·        Must be studied by HACCP

·        Must allow for sampling &monitoring whenever required

·        Equipment to be designed to avoid dead space , while it should be easy to clean ,self draining, easy to inspection chance of any built up of condensate

·        Must be easy to clean , easy to maintain

·        Design to prevent adulteration from lubricants ,fuel , metal fragments , contaminated water & steam etc.

·        Equipment to be from nontoxic materials, corrosion resistant , can withstand action of cleaning & sanitizing agents

·        lines with open products to be covered

·        Auxiliary equipment storage at proper place to avoid gathering of dust.

5.      SERVICES

·        Services must not become source of contamination by direct or indirect contact with the product .Specify food grade.

·        Pipes and cables should not allow build up of contaminants or pests

·        Services are not to be source of toxic chemicals.

·        Regular monitoring and maintenance.

·        Water used in processing to be of potable quality and in sufficient quantity.

·        Cooling towers to be properly maintained.

·        All services line to be clearly coded or colored.

·        Clean room ducts to be located preferably outside and with openings for easy cleaning and inspection.

·        Locate power or control units in a separate room or outside processing area.

·        Sewage disposal to be in adequate sewerage system.

·        Incinerator is to be of proper design, proper capacity and non polluting and safe.

6.      MAINTENANCE

·        There must be an maintenance schedule.

·        Food and equipment to be protected during maintenance.

·        All type of temperature recorders, pressure gauges and weighing machine to be well maintained.

·        All maintenance tools to be in perfect condition.

7.      RAW MATERIAL

·        All raw material are to be as per established specifications including quality certificate, weight, packing, shelf life indication where required and properly labelled.

·        All suppliers must comply with GMP.

·        Transport condition from supplier to factory must not result in contamination on damage or leakage.

·        All raw materials to be stored in dedicated places including segregation or controlled environment if required.

·        All raw materials to be released by properly laid procedure for production.

·        Rejected lots must be handled by proper procedure.

·        Shelf life expired materials also to be disposed of as per procedure.

·        Aged material to be analyzed before release.

·        Used packing material for raw material to be properly stored and disposed to avoid any pollution in environment.

8.      PROCESSING

·        HACCP study is to be done to specify critical control points.

·        Quality monitoring documents to be available with production department.

·        Wherever needed metal detectors are to be used.

·        All the analytical equipment placed in on-line lab to be checked as per documented plan for the accuracy.

·        Work in progress to be properly stored and documented to avoid any mishap.

·        Rework to be properly handled to avoid any quality mishap.

·        Safety precautions for specific processes, workman or equipment to be clearly understood.

·        Process environment to be always safe for workman.

·        Packaging material to be properly handled to avoid any contamination.

·        Rubbish disposable shall be so conveyed, stored and disposed that it does not become breeding ground or contaminating source.

9.      CLEANING

·        Only approved safe cleaning and sanitizing agents to be used.

·        Cleaning must precede disinfection.

·        All cleaning must be supervised and monitored.

·        Chemicals must not contaminate products.

·        Personal safety is must during cleaning.

·        Dedicated cleaning area for loose articles must be in place.

10.  STORAGE/TRANSPORT/DISTRIBUTION

·        Maintenance of product quality must be assured after production.

·        Products must be protected during storage and transportation against any physical chemical and microbial contamination.  Any product deterioration must also be taking care of.

·        Good commercial practice applies at all points’ up to point of consumption.

11.  PERSONNAL

·        Selection of personnel to be in line with the requirement of specific jobs.

·        All personnel employed in factory are to be free from contagious diseases.

·        High standard of personal hygiene is must for every employee at all times.

·        Proper change rooms, storage, space, rest room to be provided.

·        First aid facilities to be always available.

·        Protective clothing and foot ware, gloves to be provided keeping in mind suitability to be nature of work and climate.

·        Risk of foreign material originating from personnel to be prevented.

·        Everyone entering the food handling area must adhere to GMP rules.

·        Regular training of personnel on GMP is to be conducted.

·        Regular medical examination of personnel to be done at least once in a year.

12.  PEST PREVENTION

·        All efforts must be made to prevent products from being contaminated by pest or their excreta.

·        Pest prevention is to be responsibility of suppliers and factory and all other agencies involved in handling food products.

·        Chemical and physical preventive or control measures must not adversely affect products or their packing.

 The GMPs target those people in contact with food or food contact surfaces. Workers are taught to adhere.