GMP AUDIT Based on cGMP 21 CFR 110


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10 b6).10 –a. 8. Page 2 of 17 . foreign material control. uniform or over coats.10b7) Observations Rating 2.b) Are foods handling persons medically examined. shoe covers. before their appointment.10 b) Are the delegates are competent and clearly identified (110.10 b4) Does the plant have delegates (supervisory personnel’s) in different department for identifying sanitation failures & other compliances? (110. (110. caps. 7. Staffs wearing outer garments suitable to the operation to protect against food contamination (110. 3. This includes safety shoes. 6. 4. Personal hygiene?.10) Fully Satisfied 5 Partly Satisfied 3 Not Satisfied N/A 0 Sl.10b) Are personnel keeping their nails short and clean and wash their hands and nails with soap and water or detergents before the start of work. 13. # 1.10d) Staff must follow the correct procedures when entering the department wearing where appropriate in an effective manner – hair nets. jewellery policy.10a) All employees must wear the correct. 9. Checks – General Provisions Does the plant having policy for Disease control. There must be certificates to support this (110. 5. beard covers etc (110. noses and hand gloves to prevent contamination of foods (110. clean. 11. sores or any communicable diseases is isolated from food handling area till recovery (110.10 –c) If any personnel who are infected with wound. by the responsible official medical authorities to the requirements stated by the concerned department in the Ministry of Health? All staff who undertakes category-1 and category 2 roles must have a valid Baladiah Health Certificates. head caps covering complete hair exposing area and employees exposed to direct foods like in mixing area should wear masks on their mouths.10b1) Storing clothing or other personal belongings are not practised in the food production area (110. protective clothing in the correct manner. 12.SECTION-1 – PERSONNEL & PERSONNEL PRACTICES (110. All staff must have undergone the basic hygienetraining course. 10. (110.10b3) Is all kind of jewellery or wretch watches not worn to avoid their contact with food products? (110.

handling and packaging process and in the storage area of the plant (110. spitting.10b8). 15. 19. drinking. Section-1 Performance Points Scored Points Available % SECTION-2 – BUILDINGS AND FACILITIES (110. During the manufacturing process. tobacco in any form is prohibited during the manufacturing. 16. Notes All staff must have the correct level of hand hygiene and follow the appropriate hand hygiene practices including hand washing and sanitizing (110. and also not coughing or sneezing near any food. ears. Contractors must comply with company regulations. 17. nose cleaning. eyes.14.20) Page 3 of 17 . Personals are not sleeping or lying in a processing or food handling areas or in food stores (110. chewing of gum and the use of snuff. Visitors must comply with company regulations.10b9). 18. nose or scalp. the worker are not applying their finger to their mouth.10b2. b3) Are eating.

5/3/0 8.10a2? Does the plant have adequate draining areas to prevent contamination to food by seepage. of equipment and storage of materials as is necessary for the maintenance of sanitary operations and the production of safe food 110. construction and design facilitate maintenance . dust. 4.20a3? Is design easily allow for sufficient maintenance and cleaning operation and for sound hygienic control at all the stages of production Waste disposal: Does the plant operating system for waste disposal carried out in a systematic manner to avoid contamination of potable water sources and foods.20a1? Does the plant maintain roads.20a4? Does the plant grounds are bordered by grounds that are not under the plant control and not maintained as per 1 to 8? (110.20 Page 4 of 17 .20A Is building designed to prevent the entrance and harbouring of pests. # 1. 9. 5/3/0 7. Checks Is any objectionable odours. and sanitary operations for food manufacturing purposes (110. yards and parking lots so that they do not constitute a source of contamination in areas where food is exposed 110. birds and environment contaminants such as smoke and dust 110. Are plumbing lines and waste disposals approved by the official hygienic authorities? Are they covered to prevent the diffusion.odours and the appearance of pests and insects 110.20a1? Does the plant regular remove litter and waste. foot borne filth. 2. 6.20b)? 11 Does the plant have sufficient space for placement .Fully Satisfied 5 Partly Satisfied 3 Not Satisfied N/A 0 Sl . or providing a breeding place for pests 110. or other contaminants near or around the plant building 110. 5/3/0 5.20a) Is building sound and perfect Observations Rating 5/3/0 5/3/0 3. cutting weeds or grass within the immediate vicinity of the plant building or structures 110. smoke. insects. Does the plant building & structures is suitable in 10 size.

17 . are smooth. enclosed systems or other effective means 110. 5/3/0 15 .b1? 12 . air flow.insulating bricks. Is floor washable and cleanable. non absorbent. non toxic and free from crevices and pits. partition. Are processing space and rooms are provided with internal ventilation means (110. Stair / Pavements / Lifts: Are they designed to avoid contamination of food and to facilitate the process of cleaning them frequently Doors: Are doors have smooth and non absorbent surfaces. 5/3/0 21 . 18 . and are designed in such a way as to be tightly self closed Windows and other openings: Are constructed as to avoid accumulation of dirt. alkalizes and steam. 14 . easily cleaned and preferable painted with a harmless paint of light colour and free from crevices Ceiling: Are ceiling constructed to prevent the accumulation of dirt. steam condensation and dust to remove contaminated air. 19 .20B4? Walls: Are walls are built of heat.20b6). from the arrival of raw material to the complete processing of the finished product. Are having smooth and non absorbent surfaces. washable. Is floor slope to the drain system 110. Does the plant have separations of operations in which contamination is likely to occur by one or more of the following means: location. 5/3/0 5/3/0 5/3/0 5/3/0 20 . 13 . and to lead to suitable conditions for processing Floor: If floor made of water proof and non absorbent materials. 5/3/0 Page 5 of 17 .20b2? Does the plant indoor & outdoor is checked regularly for pests and pest infestation? Is plant designed as to apply hygienic operation in a regulated flow in the process lines. time. water proof. condensation and mould development and are easily cleaned. 5/3/0 16 . insects and rodents) and designed in such a way as to facilitate their cleaning and maintenance. Is floor affected by weak acids. Are all internal window sills if any to be sloping so that they may not be used as shelves? Are windows tightly self closed Ventilation: Is ventilation provided to prevent excessive heat. non slippery. Is direction of air flow is from clean area to contaminated area (no air flow allowed from contaminated area to clean area). Are opening of windows provided with suitable net screens made of non corrosive materials (to prevent entrance of flies.

shall be of the type and maintain in a way that prevents contamination of food in case they are broken.37 a) 5/3/0 5/3/0 5/3/0 5/3/0 5/3/0 5/3/0 5/3/0 Page 6 of 17 . 23 . Are kept clean and provided with suitable cleaning material. 24 . 27 . being in full view of the working places.C. Are electric bulbs fixed and suspended over process lines at all stages of production.37e)? Potable water: Is provided in sufficient amounts and suitably protected against contamination. Are disposable cups or direct drinking water facility is available. Is conforming to the Gulf standard concerned with " Bottled and un-bottled drinking water: to be approved by Standardization and Metrology Organization for G.22 . and are provided with hand washing and drying facilities as mentioned in Gulf standards Hand-washing facilities: Are there adequate and convenient facilities for personnel to wash and dry their hands.37 a) Does the plant have plumbing adequate in size and adequately installed to carryout sufficient quantities of water to required locations throughout the plant (110. Is light sufficient to avoid discoloration. Toilet rooms: Are constructed in such a way to facilitate elimination of wastes under hygienic conditions and are provided with self closing doors. 28 . are provided wherever necessary. Bathrooms are not directly opening into food handling places. Are there disposable towels at the hand washing facilities? Are these facilities kept in a sanitary condition (110. 29 . well lighted and ventilated.37a Non-potable water: Is it conform to hygienic regulations approved by official hygienic authorities and be free from microbiological contaminants. 26 . are usually kept in a sanitary condition and equipped with siphon and are suitable cooling and heating systems. 110. Is containing less than 4 per 100ml of coli form bacteria and suitable for carrying out sanitary operation (110. Lighting: Is there provision for natural or artificial lighting.C. Are walls of bathrooms lined with glazed ceramic tiles to be easily cleaned. Are shadows and strong glare are avoided (110. Are not opening directly into food handling areas. preferably painted with a harmless paint of a light colour and be free from crevices. 25 . are personnel having suitable rooms provided with special wardrobes to keep their clothes in.20b5) Dressing rooms: to change their clothes. Are work overalls and uniforms clean and dry Bath rooms: are personnel having bath rooms and are provided with sufficient hot water and cold water.

32 . fixtures. 33 . 5/3/0 5/3/0 Notes Section-2 Performance Points Scored Points Available % Page 7 of 17 .35 d2)? Does the plant have readily understandable signs directing employees handling unprotected food. 31 . 34 . and other physical facilities of the plant is maintained in a sanitary condition and kept in repair sufficient to prevent food from contamination 110. Collection and disposal of spoiled material and food equipment: Are there means to collect spoiled materials and foods and transport them to specific areas out side the plant provided (110. 36 .37f) Does the plant buildings. Does the equipment and utensils used in continuous production is cleaned and sanitized as necessary (110.30 .35b Does the plant identified Toxic Cleaning material & pesticide and stored in proper way that protects against contamination of food? Does the pest control program is available to exclude pests from the processing area and pesticide use data sheet available?. 35 . or surfaces etc.35 a? Does the plant ensure the cleaning compounds and sanitizing agents in used in cleaning and sanitizing procedures are free from micro organism and capable to serve the purpose 110. packaging materials. wash and sanitize their hands etc posted in processing room & other area where employees may handle such food materials.

40a)? Whether the freezer and cold storage compartment used to store and hold food is fitted with an indicating thermometer.SECTION-3 – EQUIPMENTS & UTENSILS (110. 17 5/3/0 5/3/0 5/3/0 5/3/0 5/3/0 5/3/0 Page 8 of 17 .40a) Is equipments and utensils are designed and fixed in a way to prevent hygienic hazard (110.40 a) Food contact surface are durable to frequent wash and disinfection (110. # 1. or temperature recording device to show accurate temperature within the compartment and Observations Rating 5/3/0 5/3/0 5/3/0 5/3/0 5/3/0 5/3/0 5/3/0 5/3/0 9. temperature measuring device. free from pits. 5/3/0 10 . Checks Surface in contact with foods are non-toxic Surface in contact with foods are not giving any objectionable odour and taste Food contact surface are corrosion.resistant (110.30) Fully Satisfied 5 Partly Satisfied 3 Not Satisfied N/A 0 Sl . 12 . 14 . 3. 15 .40a) Is equipments and utensils are designed and fixed in a way to easily clean and sterilized (110.40a) Food packing material are non and non absorbent and are not reacting with the product (110. 13 .40a) Steam food boilers are non porous and nonabsorbent and are not reacting with the product (110. 16 .40a) If food boilers are available then the joints between the boilers are accessible for cleaning (110.40a) Are industrial safety and protection means provided for sharp ended equipments and utensils (110. 2. 5. 11 .40a) No copper or its alloys are used on the surfaces used in direct contact with food (110. 4. crevices and loose scales No galvanized iron is used for the surface contacting foods in the food processing equipment No alloys containing lead or antimony or cadmium plating are used for the surface containing foods in the processing equipment (110.40a) Plastic or galss used in manufacturing food processing equipments are abrasion resistant and are not containing phenols or free formaldehyde or any other substances affecting the characteristics of the food with which it comes in contact (110. 6. 7.40a) Surfaces in contact with foods are smooth. 8.

40f)? Whether the plant assure the compressed air or other gases mechanically introduced into food to 19 clean food-contact surfaces or equipment is treated . adequately maintained and adequate in number for their designated uses (110. acidity.fitted with an automatic alarm system to indicate a significant temperature change in manual operation (110. maintain in an appropriate sanitary condition (110.40g? Notes Section-3 Performance Points Scored Points Available % Page 9 of 17 . accurate.40 d) Whether the instruments and controls used for measuring. water activity or other condition is . regulating or recording temperatures. in such a way that food is not contaminated with unlawful indirect food additives 110. 18 pH.40e)? Whether the holding. conveying & manufacturing 17 system design and construction enables them to .

5/3/0 6. preparing. raw material is inspected.SECTION-4 –PROCESS CONTROLS (110.C. or at a convenient point within it.80a5) Are inspection and sorting done prior to introduction into processing line. 5/3/0 5. 110. transporting. 2. 3. sorted and selected as required to remove unsuitable materials.80)? Does the plant have one or more individual competent individual who looks after (supervise) the overall sanitation of the plant (110. 5/3/0 Page 10 of 17 .80)? Are raw material procedures in place – inspected. 5/3/0 7. Are these steps carried out under hygienic conditions.C. so that only sound and clean raw Observations Rating 1. segregations.80a4? Is water used for conveying raw materials. manufacturing. packaging and storing of food is conducted as per adequate sanitation principles (110. 8.80)? Does the plant have procedure to eliminate the food that has been contaminated – rejection or if permissible any process to eliminate the contamination (110. handled properly and stored in appropriate condition to protect contamination 110. 9.80) Fully Satisfied 5 Partly Satisfied 3 Not Satisfied N/A 0 Sl .80a1 Does the company purchase all materials under a supplier’s guarantee or certification as per the examination of the materials to assure there is no contamination 110. inspecting. 4. segregated. # Checks Does the plant have operations in receiving. comply with the gulf standards concerned with "Bottled and un-bottled Drinking water" approved by Standardization and Metrology Organization for G.80a1?.80a4? Are the RM’s are stored in adequate required condition (temperature & RH) and do the company have sufficient record to assure the monitoring of the same to safeguard the RMs (110. Are raw material stored in the plant premises under conditions that protects them against contamination and infestation and quick deterioration? Are stores and their doors and windows constructed to prevent entrance of rodents 110.

does . and is treated by a way that does not cause . electronic metal detectors or other suitable effective means (110. Is product . when necessary. specified food lot which may have become contaminated or unfit for the purpose of its use shall be segregated. a . Frozen raw materials and other ingredients shall be 11 kept frozen. If thawing is required prior to use. infestation.80 b8) 18 Are methods of preservation are to protect the . product against contamination. deterioration. spoilage. Finished products are stored and transported under conditions as to preclude its contamination or 20 proliferation of micro organisms. disease d communication and any development hazardous to public health. Process products prepared for sale or those distributed during processing or packaging are coded to enable identification of lots and their 19 production date. purpose is recalculated unless suitably treated to maintain it non hazardous for public health. traps. protected against deterioration or containers damage? 5/3/0 5/3/0 5/3/0 5/3/0 5/3/0 5/3/0 5/3/0 5/3/0 5/3/0 Page 11 of 17 . 16 Is packaging carried out under suitable hygienic . Are random samples drawn from processing line 13 and from the finished product to assure safety of . tasteless 15 and odourless and shall assure convenient . Is packaging material a non. protection of the product against contamination. .materials are processed? Are raw materials washed as needed to remove dust 10 or other contaminants? Is this water used for such . conditions? Does the plant have effective measures to protect against the inclusion of metal or other extraneous 17 material in food such as sieves. or the development of pathogenic micro organisms or toxicity. production? Is packaging material containing any substance causing objectionable organleptic changes in the 14 product. magnets.absorbent. contamination. the company assure the thawing procedure is safe and not adding any contamination 110. toxicity or affect the foods with which they come into contact. so that.80 a6? Is preparatory operations leading to the finished product and the packaging operations is timed to permit expeditions handling of consecutive units in 12 production under conditions which would prevent .

24 .93)? 5/3/0 5/3/0 5/3/0 Notes Section-4 Performance Points Scored Points Available % Page 12 of 17 . 22 . D Are periodic inspection is carried out during storage of finished product to ensure that the food is fit for human consumption and that it complies with the with the standard specifications of the finished product .21 .80b6? Does the company use QC operation to assure the quality of manufactured product in which the critical control points are identified and controlled during manufacturing (110. 23 .80bi) Do the company’s storage and transportation of finished food is under condition that will protect food against physical. Are FG store rooms are moisture free and air conditioned and are refrigerated and is rodent proof 110. chemical and microbial contamination as well deterioration of food and the container (110.

Correct cleaning-out-of-place equipment available. 4. bucket elevators. and conveyors frequently inspected for detecting the presence of insect secretions and eggs in crevices? Are pest resistance substances used for rodents? Are they used in a manner so that they are not leading to contamination of foods. Records to support this must be available for review. 5/3/0 5/3/0 Page 13 of 17 . # 1. Checks Are there periodic controls on all outside pest breeding places. Fogging regimes in place. 2. Observations Rating 5/3/0 5/3/0 5/3/0 5/3/0 5/3/0 5/3/0 5/3/0 PEST CONTROL Sl . Proper storage of change parts and flow bends. # 1. 2. 4.SECTION-5 Fully Satisfied 5 Partly Satisfied 3 Not Satisfied N/A 0 CLEANING Sl . drains etc must be in place and followed. 6. and their toxicity is low for humans? Are contaminated equipments and utensils thoroughly cleaned to remove pesticide residues Observations Rating 5/3/0 5/3/0 3. Records to support this must be available for review. Checks Cleaning regimes for equipment must be in place and followed. Cleaning Effectiveness Correct cleaning utensils for all cleaning purposes must be available and used in the appropriate manners and stored properly when not in use. 7. 5. walls. Cleaning regimes for floors. as well as all inside harbouring and hibernating spots? Are floors. 3. Records to support this must be available for review. walls.

done. Open containers of Ingredients. Observations Rating 5/3/0 5/3/0 5/3/0 5/3/0 FOREIGN BODY CONTAMINATION Sl. Is extreme care is taken to avoid food contamination. 3. Checks Tightening of loose nuts/ screws in process equipments immediately after maintenance jobs. Are pesticides stored in locked rooms and are used only for that purpose and dispensed and handled by authorization. is of good wetting or penetrating action. 4 Are staffs in laboratory qualified to carry out the .process materials and finished products. samples representative of the production for analysis purpose. washers etc. # 1.corrosive for metal surfaces. 3 Is calibration of lab equipments used for testing is . is non. are periodically taking . Observations Rating 5/3/0 5/3/0 5/3/0 5/3/0 Page 14 of 17 . Doors must be closed and door seals must be intact.5. Insect-o-cutters in correct position. nuts. screws. Storage of Miscellaneous small engineering items. with an emulsifying action on fat and dissolving action on food residues and having germicidal action. and through properly trained personnel. # Checks 1 Is each plant is having a special laboratory to . 2. after application of pesticides? Is cleaner used for cleaning is completely soluble. LABORATORY CONTROL Sl. Are official authorities. 7. Use of Packaging material for drinking purposes. carry out tests necessary to assure the safety of the products. In. each according to its 2 duties and functions. to assure the safety of the product and its compliance with the standards. in food containers. 4. test required to make sure the product is safe and is as per quality standards. 6. operational and cleaned regularly.

8. S. Inversion. Checks Minimal levels of waste in the department at any time. A corrective action for identified foreign body is taken effectively. Checks Crates and pallets must only be used for intended purpose. 3. Rating 5/3/0 Page 15 of 17 . 11. Condition of overhead pipes. # 1. Procedures for managing.5. cleaning of cans. Condition of. collecting and disposing of waste in place and adherence to procedures. Thorough weekly cleaning for Inverters performed regularly and records are maintained 5/3/0 5/3/0 5/3/0 5/3/0 5/3/0 5/3/0 5/3/0 5/3/0 5/3/0 5/3/0 WASTAGE MANAGEMENT Fully Satisfied 5 Partly Satisfied 3 Not Satisfied N/A 0 Sl. 4. Presence of controlling system of knives in the departments. 6. Exposure of the bottles during production stoppages. Inspection of process equipments and conveyor hoods for foreign body. 10. 7. # 1. bottles and other containers before filling. 2. Proper containers for the collection and disposal of waste. Exposed products to be discarded up on resumption of production. 14. 12. Proper conveyor covers prior to filling section for all fillers Cleaning of Inverter FB traps and identification of foreign bodies need to done and recorded. Cleanliness – Regime & actual practice. 13. 9. Observation Rating 5/3/0 5/3/0 5/3/0 5/3/0 MISCELLANEOUS Sl.KNIVES.

Ingredient must be stored in sealed containers and labelled for traceability. 5. Hazardous materials must be stored away from raw materials and finished products. 6.2. 5/3/0 5/3/0 5/3/0 5/3/0 5/3/0 5/3/0 Section-5 Performance Points Scored Points Available % Page 16 of 17 . 4. Filling and Packing department should be separated to reduce any contamination from one section to another. 8. Rework must be properly stored and labelled. All crates and pallets that enter department must be cleaned. Notes Packaging must only used for intended purpose. 7. 3. All risky / dangerous material / pipe lines properly tagged / protected Is Mixing. Processing.

GMP Audit Results Summary Function or Location Audited By Date of Audit Self – Audit or Independent Independent Section-1 Personnel & Personnel Practices Section-2 Building & Facilities Points Scored (a) Points Available (b) % Points Scored (a) Points Available (b) % Section-3 Equipment and Utensils Section-4 Process Controls Points Scored (a) Points Available (b) % Points Scored (a) Points Available (b) % Section-5 Miscellaneous Points Scored (a) Points Available (b) % Overall Performance Points Scored (a) Points Available (b) % Page 17 of 17 .

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