53516697 gmp checklist

GMP AUDITBased on cGMP 21 CFR 110

SECTION:

AUDIT DATE:

AUDITED BY:

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SECTION-1 – PERSONNEL & PERSONNEL PRACTICES (110.10)

Fully Satisfied

5

Partly Satisfied

3

Not Satisfied

0N/A

Sl. # Checks – General Provisions Observations Rating

1.Does the plant having policy for Disease control, foreign material control, jewellery policy, Personal hygiene?. (110.10 –a,b)

2.Are foods handling persons medically examined, before their appointment, by the responsible official medical authorities to the requirements stated by the concerned department in the Ministry of Health?

3. All staff who undertakes category-1 and category 2 roles must have a valid Baladiah Health Certificates.

4.All staff must have undergone the basic hygiene-training course. There must be certificates to support this (110.10 –c)

5.If any personnel who are infected with wound, sores or any communicable diseases is isolated from food handling area till recovery (110.10a)

6.

All employees must wear the correct, clean, protective clothing in the correct manner. This includes safety shoes; uniform or over coats, shoe covers, head caps covering complete hair exposing area and employees exposed to direct foods like in mixing area should wear masks on their mouths, noses and hand gloves to prevent contamination of foods (110.10b)

7.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. (110.10b3)

8. Is all kind of jewellery or wretch watches not worn to avoid their contact with food products? (110.10 b4)

9.Does the plant have delegates (supervisory personnel’s) in different department for identifying sanitation failures & other compliances? (110.10 b)

10. Are the delegates are competent and clearly identified (110.10d)

11.Staff must follow the correct procedures when entering the department wearing where appropriate in an effective manner – hair nets, caps, beard covers etc (110.10 b6).

12.Staffs wearing outer garments suitable to the operation to protect against food contamination (110.10b1)

13. Storing clothing or other personal belongings are not practised in the food production area (110.10b7)

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14.All staff must have the correct level of hand hygiene and follow the appropriate hand hygiene practices including hand washing and sanitizing (110.10b2, b3)

15.

Are eating, drinking, spitting, nose cleaning, chewing of gum and the use of snuff, tobacco in any form is prohibited during the manufacturing, handling and packaging process and in the storage area of the plant (110.10b8).

16. Personals are not sleeping or lying in a processing or food handling areas or in food stores (110.10b9).

17.During the manufacturing process, the worker are not applying their finger to their mouth, eyes, ears, nose or scalp, and also not coughing or sneezing near any food.

18.Contractors must comply with company regulations.

19.Visitors must comply with company regulations.

Notes

Section-1 Performance

Points Scored Points Available %

SECTION-2 – BUILDINGS AND FACILITIES (110.20)

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Fully Satisfied

5

Partly Satisfied

3

Not Satisfied

0N/A

Sl. #

Checks Observations Rating

1.Is any objectionable odours, smoke, dust, or other contaminants near or around the plant building 110.20A

5 / 3 / 0

2.Is building designed to prevent the entrance and harbouring of pests, insects, birds and environment contaminants such as smoke and dust 110.20a1?

5 / 3 / 0

3.

Does the plant regular remove litter and waste, cutting weeds or grass within the immediate vicinity of the plant building or structures 110.20a1?

4.

Does the plant maintain roads, yards and parking lots so that they do not constitute a source of contamination in areas where food is exposed 110.10a2?

5 / 3 / 0

5.

Does the plant have adequate draining areas to prevent contamination to food by seepage, foot borne filth, or providing a breeding place for pests 110.20a3?

6.Is design easily allow for sufficient maintenance and cleaning operation and for sound hygienic control at all the stages of production

5 / 3 / 0

7.

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. 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 110.20a4?

5 / 3 / 0

8.Does the plant grounds are bordered by grounds that are not under the plant control and not maintained as per 1 to 8? (110.20a)

9. Is building sound and perfect

10.

Does the plant building & structures is suitable in size, construction and design facilitate maintenance and sanitary operations for food manufacturing purposes (110.20b)?

11.

Does the plant have sufficient space for placement of equipment and storage of materials as is necessary for the maintenance of sanitary operations and the production of safe food 110.20

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b1?

12.

Does the plant have separations of operations in which contamination is likely to occur by one or more of the following means: location, time, partition, air flow, enclosed systems or other effective means 110.20b2?

13.

Does the plant indoor & outdoor is checked regularly for pests and pest infestation?

14.

Is plant designed as to apply hygienic operation in a regulated flow in the process lines, from the arrival of raw material to the complete processing of the finished product, and to lead to suitable conditions for processing

5 / 3 / 0

15.

Floor: If floor made of water proof and non absorbent materials. Is floor washable and cleanable, non slippery, non toxic and free from crevices and pits. Is floor affected by weak acids, alkalizes and steam. Is floor slope to the drain system 110.20B4?

5 / 3 / 0

16.

Walls: Are walls are built of heat- insulating bricks. are smooth, water proof, non absorbent, washable, easily cleaned and preferable painted with a harmless paint of light colour and free from crevices

5 / 3 / 0

17.

Ceiling: Are ceiling constructed to prevent the accumulation of dirt, condensation and mould development and are easily cleaned.

5 / 3 / 0

18.

Stair / Pavements / Lifts: Are they designed to avoid contamination of food and to facilitate the process of cleaning them frequently

5 / 3 / 0

19.

Doors: Are doors have smooth and non absorbent surfaces, and are designed in such a way as to be tightly self closed

5 / 3 / 0

20.

Windows and other openings: Are constructed as to avoid accumulation of dirt. Are opening of windows provided with suitable net screens made of non corrosive materials (to prevent entrance of flies, insects and rodents) and designed in such a way as to facilitate their cleaning and maintenance. Are having smooth and non absorbent surfaces. Are all internal window sills if any to be sloping so that they may not be used as shelves? Are windows tightly self closed

5 / 3 / 0

21.

Ventilation: Is ventilation provided to prevent excessive heat, steam condensation and dust to remove contaminated air. Is direction of air flow is from clean area to contaminated area (no air flow allowed from contaminated area to clean area). Are processing space and rooms are provided with internal ventilation means (110.20b6).

5 / 3 / 0

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22.

Lighting: Is there provision for natural or artificial lighting. Is light sufficient to avoid discoloration. Are electric bulbs fixed and suspended over process lines at all stages of production- shall be of the type and maintain in a way that prevents contamination of food in case they are broken. Are shadows and strong glare are avoided (110.20b5)

5 / 3 / 0

23.

Dressing rooms: to change their clothes, are personnel having suitable rooms provided with special wardrobes to keep their clothes in. Are work overalls and uniforms clean and dry

5 / 3 / 0

24.

Bath rooms: are personnel having bath rooms and are provided with sufficient hot water and cold water. Bathrooms are not directly opening into food handling places. Are kept clean and provided with suitable cleaning material. Are walls of bathrooms lined with glazed ceramic tiles to be easily cleaned, preferably painted with a harmless paint of a light colour and be free from crevices.

5 / 3 / 0

25.

Toilet rooms: Are constructed in such a way to facilitate elimination of wastes under hygienic conditions and are provided with self closing doors, well lighted and ventilated. Are not opening directly into food handling areas, are usually kept in a sanitary condition and equipped with siphon and are suitable cooling and heating systems, and are provided with hand washing and drying facilities as mentioned in Gulf standards

5 / 3 / 0

26.

Hand-washing facilities: Are there adequate and convenient facilities for personnel to wash and dry their hands, are provided wherever necessary, being in full view of the working places. Are there disposable towels at the hand washing facilities? Are these facilities kept in a sanitary condition (110.37e)?

5 / 3 / 0

27.

Potable water: Is provided in sufficient amounts and suitably protected against contamination. Is conforming to the Gulf standard concerned with " Bottled and un-bottled drinking water: to be approved by Standardization and Metrology Organization for G.C.C. Are disposable cups or direct drinking water facility is available. 110.37a

5 / 3 / 0

28.

Non-potable water: Is it conform to hygienic regulations approved by official hygienic authorities and be free from microbiological contaminants. Is containing less than 4 per 100ml of coli form bacteria and suitable for carrying out sanitary operation (110.37 a)

5 / 3 / 0

29.

Does the plant have plumbing adequate in size and adequately installed to carryout sufficient quantities of water to required locations throughout the plant (110.37 a)

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30.

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 (110.37f)

5 / 3 / 0

31.

Does the plant buildings, fixtures, and other physical facilities of the plant is maintained in a sanitary condition and kept in repair sufficient to prevent food from contamination 110.35 a?

32.

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 110.35b

5 / 3 / 0

33.

Does the plant identified Toxic Cleaning material & pesticide and stored in proper way that protects against contamination of food?

34.

Does the pest control program is available to exclude pests from the processing area and pesticide use data sheet available?.

35.

Does the equipment and utensils used in continuous production is cleaned and sanitized as necessary (110.35 d2)?

36.

Does the plant have readily understandable signs directing employees handling unprotected food, packaging materials, wash and sanitize their hands etc posted in processing room & other area where employees may handle such food materials, or surfaces etc.

Notes



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SECTION-3 – EQUIPMENTS & UTENSILS (110.30)

Fully Satisfied

5

Partly Satisfied

3

Not Satisfied

0N/A

Sl. #


1. Surface in contact with foods are non-toxic 5 / 3 / 0

2.Surface in contact with foods are not giving any objectionable odour and taste

5 / 3 / 0

3.Food contact surface are corrosion- resistant (110.40 a)

5 / 3 / 0

4.Food contact surface are durable to frequent wash and disinfection (110.40a)

5 / 3 / 0

5.Surfaces in contact with foods are smooth, free from pits, crevices and loose scales

5 / 3 / 0

6.No galvanized iron is used for the surface contacting foods in the food processing equipment

5 / 3 / 0

7.No alloys containing lead or antimony or cadmium plating are used for the surface containing foods in the processing equipment (110.40a)

5 / 3 / 0

8.No copper or its alloys are used on the surfaces used in direct contact with food (110.40a)

5 / 3 / 0

9.

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 (110.40a)

5 / 3 / 0

10.

Steam food boilers are non porous and non- absorbent and are not reacting with the product (110.40a)

5 / 3 / 0

11.

Food packing material are non and non absorbent and are not reacting with the product (110.40a)

5 / 3 / 0

12.

If food boilers are available then the joints between the boilers are accessible for cleaning (110.40a)

5 / 3 / 0

13.

Is equipments and utensils are designed and fixed in a way to prevent hygienic hazard (110.40a)

5 / 3 / 0

14.

Is equipments and utensils are designed and fixed in a way to easily clean and sterilized (110.40a)

5 / 3 / 0

15.

Are industrial safety and protection means provided for sharp ended equipments and utensils (110.40a)?

5 / 3 / 0

16.17

Whether the freezer and cold storage compartment used to store and hold food is fitted with an indicating thermometer, temperature measuring device, or temperature recording device to show accurate temperature within the compartment and

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fitted with an automatic alarm system to indicate a significant temperature change in manual operation (110.40e)?

17.

Whether the holding, conveying & manufacturing system design and construction enables them to maintain in an appropriate sanitary condition (110.40 d)

18.

Whether the instruments and controls used for measuring, regulating or recording temperatures, pH, acidity, water activity or other condition is accurate, adequately maintained and adequate in number for their designated uses (110.40f)?

19.

Whether the plant assure the compressed air or other gases mechanically introduced into food to clean food-contact surfaces or equipment is treated in such a way that food is not contaminated with unlawful indirect food additives 110.40g?

Notes



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SECTION-4 –PROCESS CONTROLS (110.80)

Fully Satisfied

5

Partly Satisfied

3

Not Satisfied

0N/A

Sl. #


1.

Does the plant have operations in receiving, inspecting, transporting, segregations, preparing, manufacturing, packaging and storing of food is conducted as per adequate sanitation principles (110.80)?

2.Does the plant have one or more individual competent individual who looks after (supervise) the overall sanitation of the plant (110.80)?

3.

Does the plant have procedure to eliminate the food that has been contaminated – rejection or if permissible any process to eliminate the contamination (110.80)?

4.

Are raw material procedures in place – inspected, segregated, handled properly and stored in appropriate condition to protect contamination 110.80a1?.

5 / 3 / 0

5.

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 110.80a4?

5 / 3 / 0

6.

Is water used for conveying raw materials, comply with the gulf standards concerned with "Bottled and un-bottled Drinking water" approved by Standardization and Metrology Organization for G.C.C. 110.80a1

5 / 3 / 0

7.

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 110.80a4?

8.

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 (110.80a5)

9. Are inspection and sorting done prior to introduction into processing line, or at a convenient point within it, raw material is inspected, sorted and selected as required to remove unsuitable materials. Are these steps carried out under hygienic conditions, so that only sound and clean raw

5 / 3 / 0

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materials are processed?

10.

Are raw materials washed as needed to remove dust or other contaminants? Is this water used for such purpose is recalculated unless suitably treated to maintain it non hazardous for public health.

5 / 3 / 0

11.

Frozen raw materials and other ingredients shall be kept frozen. If thawing is required prior to use, does the company assure the thawing procedure is safe and not adding any contamination 110.80 a6?

12.

Is preparatory operations leading to the finished product and the packaging operations is timed to permit expeditions handling of consecutive units in production under conditions which would prevent contamination, deterioration, spoilage, or the development of pathogenic micro organisms or toxicity.

5 / 3 / 0

13.

Are random samples drawn from processing line and from the finished product to assure safety of production?

5 / 3 / 0

14.

Is packaging material containing any substance causing objectionable organleptic changes in the product, and is treated by a way that does not cause toxicity or affect the foods with which they come into contact.

5 / 3 / 0

15.

Is packaging material a non- absorbent, tasteless and odourless and shall assure convenient protection of the product against contamination.

5 / 3 / 0

16.

Is packaging carried out under suitable hygienic conditions?

5 / 3 / 0

17.

Does the plant have effective measures to protect against the inclusion of metal or other extraneous material in food such as sieves, traps, magnets, electronic metal detectors or other suitable effective means (110.80 b8)

18.d

Are methods of preservation are to protect the product against contamination, infestation, disease communication and any development hazardous to public health.

5 / 3 / 0

19.

Process products prepared for sale or those distributed during processing or packaging are coded to enable identification of lots and their production date, so that, when necessary, a specified food lot which may have become contaminated or unfit for the purpose of its use shall be segregated.

5 / 3 / 0

20.

Finished products are stored and transported under conditions as to preclude its contamination or proliferation of micro organisms. Is product protected against deterioration or containers damage?

5 / 3 / 0

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21.

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 .

5 / 3 / 0

22.

Are FG store rooms are moisture free and air conditioned and are refrigerated and is rodent proof 110.80b6?

5 / 3 / 0

23.

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 (110.80bi)

5 / 3 / 0

24.D

Do the company’s storage and transportation of finished food is under condition that will protect food against physical, chemical and microbial contamination as well deterioration of food and the container (110.93)?

Notes



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SECTION-5

Fully Satisfied

5

Partly Satisfied

3

Not Satisfied

0N/A

CLEANINGSl. #


1.Cleaning regimes for equipment must be in place and followed. Records to support this must be available for review.

5 / 3 / 0

2.Cleaning regimes for floors, walls, drains etc must be in place and followed. Records to support this must be available for review.

5 / 3 / 0

3. Cleaning Effectiveness 5 / 3 / 0

4.Correct cleaning utensils for all cleaning purposes must be available and used in the appropriate manners and stored properly when not in use.

5 / 3 / 0

5. Correct cleaning-out-of-place equipment available. 5 / 3 / 0

6. Proper storage of change parts and flow bends. 5 / 3 / 0

7.Fogging regimes in place. Records to support this must be available for review.

5 / 3 / 0

PEST CONTROL

Sl. #


1.Are there periodic controls on all outside pest breeding places, as well as all inside harbouring and hibernating spots?

5 / 3 / 0

2.Are floors, walls, bucket elevators, and conveyors frequently inspected for detecting the presence of insect secretions and eggs in crevices?

5 / 3 / 0

3.

Are pest resistance substances used for rodents? Are they used in a manner so that they are not leading to contamination of foods, and their toxicity is low for humans?

5 / 3 / 0

4. Are contaminated equipments and utensils thoroughly cleaned to remove pesticide residues

5 / 3 / 0

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after application of pesticides? Is cleaner used for cleaning is completely soluble, is non- corrosive for metal surfaces, is of good wetting or penetrating action, with an emulsifying action on fat and dissolving action on food residues and having germicidal action.

5.

Are pesticides stored in locked rooms and are used only for that purpose and dispensed and handled by authorization, and through properly trained personnel. Is extreme care is taken to avoid food contamination.

6.Insect-o-cutters in correct position, operational and cleaned regularly.

7. Doors must be closed and door seals must be intact.

LABORATORY CONTROL

Sl. #


1.

Is each plant is having a special laboratory to carry out tests necessary to assure the safety of the products.

5 / 3 / 0

2.

Are official authorities, each according to its duties and functions, are periodically taking samples representative of the production for analysis purpose, to assure the safety of the product and its compliance with the standards.

5 / 3 / 0

3.

Is calibration of lab equipments used for testing is done.

5 / 3 / 0

4.

Are staffs in laboratory qualified to carry out the test required to make sure the product is safe and is as per quality standards.

5 / 3 / 0

FOREIGN BODY CONTAMINATION

Sl. #


1.Tightening of loose nuts/ screws in process equipments immediately after maintenance jobs.

5 / 3 / 0

2.Storage of Miscellaneous small engineering items, screws, nuts, washers etc. in food containers.

5 / 3 / 0

3. Use of Packaging material for drinking purposes. 5 / 3 / 0

4.Open containers of Ingredients, In- process materials and finished products.

5 / 3 / 0

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5.Inspection of process equipments and conveyor hoods for foreign body.

5 / 3 / 0

6.Inversion, cleaning of cans, bottles and other containers before filling.

5 / 3 / 0

7.Exposure of the bottles during production stoppages. Exposed products to be discarded up on resumption of production.

5 / 3 / 0

8. Condition of overhead pipes. 5 / 3 / 0

9. Condition of. S.KNIVES. 5 / 3 / 0

10.Presence of controlling system of knives in the departments.

5 / 3 / 0

11.Proper conveyor covers prior to filling section for all fillers

5 / 3 / 0

12.Cleaning of Inverter FB traps and identification of foreign bodies need to done and recorded.

5 / 3 / 0

13.A corrective action for identified foreign body is taken effectively.

5 / 3 / 0

14.Thorough weekly cleaning for Inverters performed regularly and records are maintained

5 / 3 / 0

WASTAGE MANAGEMENT

Fully Satisfied

5

Partly Satisfied

3

Not Satisfied

0N/A

Sl. #

Checks Observation Rating

1.Minimal levels of waste in the department at any time.

5 / 3 / 0

2.Procedures for managing, collecting and disposing of waste in place and adherence to procedures.

5 / 3 / 0

3.Proper containers for the collection and disposal of waste.

5 / 3 / 0

4. Cleanliness – Regime & actual practice. 5 / 3 / 0

MISCELLANEOUS

Sl. #

Checks Rating

1.Crates and pallets must only be used for intended purpose.

5 / 3 / 0

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2. Packaging must only used for intended purpose. 5 / 3 / 0

3.All crates and pallets that enter department must be cleaned.

5 / 3 / 0

4.Hazardous materials must be stored away from raw materials and finished products.

5 / 3 / 0

5.Ingredient must be stored in sealed containers and labelled for traceability.

5 / 3 / 0

6. Rework must be properly stored and labelled. 5 / 3 / 0

7.All risky / dangerous material / pipe lines properly tagged / protected

5 / 3 / 0

8.Is Mixing, Processing, Filling and Packing department should be separated to reduce any contamination from one section to another.

Notes



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GMP Audit Results Summary

Function or Location Audited By

Date of Audit Self – Audit or Independent

Independent

Section-1 Personnel &

Personnel Practices

Points Scored (a) Points Available (b) %

Section-2 Building & Facilities


Section-3 Equipment and

Utensils


Section-4Process Controls


Section-5 Miscellaneous


Overall Performance


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