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GMP AUDIT

Based on cGMP 21 CFR 110

SECTION:

AUDIT DATE:

AUDITED BY:

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SECTION-1 – PERSONNEL & PERSONNEL PRACTICES (110.10)

Fully Satisfied Partly Satisfied Not Satisfied


N/A
5 3 0

Sl. # Checks – General Provisions Observations Rating


Does the plant having policy for Disease control,
1.
foreign material control, jewellery policy, Personal
hygiene?. (110.10 –a,b)
Are foods handling persons medically examined,
2. 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.
All staff must have undergone the basic hygiene-
4.
training course. There must be certificates to support
this (110.10 –c)
If any personnel who are infected with wound, sores
5.
or any communicable diseases is isolated from food
handling area till recovery (110.10a)
All employees must wear the correct, clean,
protective clothing in the correct manner. This
includes safety shoes; uniform or over coats, shoe
6. 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)
Are personnel keeping their nails short and clean and
7.
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)
Does the plant have delegates (supervisory
9.
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)
Staff must follow the correct procedures when
11. entering the department wearing where appropriate in
an effective manner – hair nets, caps, beard covers
etc (110.10 b6).
Staffs wearing outer garments suitable to the
12.
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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All staff must have the correct level of hand hygiene
14.
and follow the appropriate hand hygiene practices
including hand washing and sanitizing (110.10b2, b3)
Are eating, drinking, spitting, nose cleaning, chewing
of gum and the use of snuff, tobacco in any form is
15.
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).
During the manufacturing process, the worker are not
17. 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 Points Scored Points Available %


Performance

SECTION-2 – BUILDINGS AND FACILITIES (110.20)

Page 3 of 17
Fully Satisfied Partly Satisfied Not Satisfied
N/A
5 3 0

Sl
. Checks Observations Rating
#
Is any objectionable odours, smoke, dust, or other
1. contaminants near or around the plant building 5/3/0
110.20A
Is building designed to prevent the entrance and
2. harbouring of pests, insects, birds and environment 5/3/0
contaminants such as smoke and dust 110.20a1?
Does the plant regular remove litter and waste,
cutting weeds or grass within the immediate
3.
vicinity of the plant building or structures
110.20a1?
Does the plant maintain roads, yards and parking
lots so that they do not constitute a source of
4. 5/3/0
contamination in areas where food is exposed
110.10a2?
Does the plant have adequate draining areas to
prevent contamination to food by seepage, foot
5.
borne filth, or providing a breeding place for pests
110.20a3?
Is design easily allow for sufficient maintenance
6. and cleaning operation and for sound hygienic 5/3/0
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. Are plumbing lines and waste
7. 5/3/0
disposals approved by the official hygienic
authorities? Are they covered to prevent the
diffusion- odours and the appearance of pests and
insects 110.20a4?
Does the plant grounds are bordered by grounds
8. that are not under the plant control and not
maintained as per 1 to 8? (110.20a)
9. Is building sound and perfect
Does the plant building & structures is suitable in
10 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?
Does the plant have separations of operations in
which contamination is likely to occur by one or
12
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?
Is plant designed as to apply hygienic operation in a
regulated flow in the process lines, from the arrival
14
of raw material to the complete processing of the 5/3/0
.
finished product, and to lead to suitable conditions
for processing
Floor: If floor made of water proof and non
absorbent materials. Is floor washable and
15 cleanable, non slippery, non toxic and free from
5/3/0
. crevices and pits. Is floor affected by weak acids,
alkalizes and steam. Is floor slope to the drain
system 110.20B4?
Walls: Are walls are built of heat- insulating
bricks. are smooth, water proof, non absorbent,
16
washable, easily cleaned and preferable painted 5/3/0
.
with a harmless paint of light colour and free from
crevices
Ceiling: Are ceiling constructed to prevent the
17
accumulation of dirt, condensation and mould 5/3/0
.
development and are easily cleaned.
Stair / Pavements / Lifts: Are they designed to
18
avoid contamination of food and to facilitate the 5/3/0
.
process of cleaning them frequently
Doors: Are doors have smooth and non absorbent
19
surfaces, and are designed in such a way as to be 5/3/0
.
tightly self closed
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
20 flies, insects and rodents) and designed in such a
5/3/0
. 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
Ventilation: Is ventilation provided to prevent
excessive heat, steam condensation and dust to
remove contaminated air. Is direction of air flow is
21
from clean area to contaminated area (no air flow 5/3/0
.
allowed from contaminated area to clean area). Are
processing space and rooms are provided with
internal ventilation means (110.20b6).

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Lighting: Is there provision for natural or artificial
lighting. Is light sufficient to avoid discoloration.
Are electric bulbs fixed and suspended over process
22
lines at all stages of production- shall be of the type 5/3/0
.
and maintain in a way that prevents contamination
of food in case they are broken. Are shadows and
strong glare are avoided (110.20b5)
Dressing rooms: to change their clothes, are
23 personnel having suitable rooms provided with
5/3/0
. special wardrobes to keep their clothes in. Are
work overalls and uniforms clean and dry
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
5/3/0
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.
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
25
directly into food handling areas, are usually kept 5/3/0
.
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
Hand-washing facilities: Are there adequate and
convenient facilities for personnel to wash and dry
their hands, are provided wherever necessary, being
26
in full view of the working places. Are there 5/3/0
.
disposable towels at the hand washing facilities?
Are these facilities kept in a sanitary condition
(110.37e)?
Potable water: Is provided in sufficient amounts
and suitably protected against contamination. Is
conforming to the Gulf standard concerned with "
27
Bottled and un-bottled drinking water: to be 5/3/0
.
approved by Standardization and Metrology
Organization for G.C.C. Are disposable cups or
direct drinking water facility is available. 110.37a
Non-potable water: Is it conform to hygienic
regulations approved by official hygienic
28 authorities and be free from microbiological
5/3/0
. contaminants. Is containing less than 4 per 100ml
of coli form bacteria and suitable for carrying out
sanitary operation (110.37 a)
Does the plant have plumbing adequate in size and
29 adequately installed to carryout sufficient quantities
. of water to required locations throughout the plant
(110.37 a)

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Collection and disposal of spoiled material and
30 food equipment: Are there means to collect
5/3/0
. spoiled materials and foods and transport them to
specific areas out side the plant provided (110.37f)
Does the plant buildings, fixtures, and other
31 physical facilities of the plant is maintained in a
. sanitary condition and kept in repair sufficient to
prevent food from contamination 110.35 a?
Does the plant ensure the cleaning compounds and
32 sanitizing agents in used in cleaning and sanitizing
5/3/0
. procedures are free from micro organism and
capable to serve the purpose 110.35b
Does the plant identified Toxic Cleaning material
33
& pesticide and stored in proper way that protects
.
against contamination of food?
Does the pest control program is available to
34
exclude pests from the processing area and
.
pesticide use data sheet available?.
Does the equipment and utensils used in continuous
35
production is cleaned and sanitized as necessary
.
(110.35 d2)?
Does the plant have readily understandable signs
directing employees handling unprotected food,
36 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

Section-2 Points Scored Points Available %


Performance

Page 7 of 17
SECTION-3 – EQUIPMENTS & UTENSILS (110.30)

Fully Satisfied Partly Satisfied Not Satisfied


N/A
5 3 0

Sl
. Checks Observations Rating
#

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

Surface in contact with foods are not giving any


2. 5/3/0
objectionable odour and taste
Food contact surface are corrosion- resistant
3. 5/3/0
(110.40 a)
Food contact surface are durable to frequent wash
4. 5/3/0
and disinfection (110.40a)
Surfaces in contact with foods are smooth, free
5. 5/3/0
from pits, crevices and loose scales
No galvanized iron is used for the surface
6. 5/3/0
contacting foods in the food processing equipment
No alloys containing lead or antimony or cadmium
7. plating are used for the surface containing foods in 5/3/0
the processing equipment (110.40a)
No copper or its alloys are used on the surfaces
8. 5/3/0
used in direct contact with food (110.40a)
Plastic or galss used in manufacturing food
processing equipments are abrasion resistant and
9. are not containing phenols or free formaldehyde or 5/3/0
any other substances affecting the characteristics of
the food with which it comes in contact (110.40a)
Steam food boilers are non porous and non-
10
absorbent and are not reacting with the product 5/3/0
.
(110.40a)
11 Food packing material are non and non absorbent
5/3/0
. and are not reacting with the product (110.40a)
12 If food boilers are available then the joints between
5/3/0
. the boilers are accessible for cleaning (110.40a)
13 Is equipments and utensils are designed and fixed
5/3/0
. in a way to prevent hygienic hazard (110.40a)
14 Is equipments and utensils are designed and fixed
5/3/0
. in a way to easily clean and sterilized (110.40a)
15 Are industrial safety and protection means provided
5/3/0
. for sharp ended equipments and utensils (110.40a)?
16 Whether the freezer and cold storage compartment
. used to store and hold food is fitted with an
17 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)?
Whether the holding, conveying & manufacturing
17 system design and construction enables them to
. maintain in an appropriate sanitary condition
(110.40 d)
Whether the instruments and controls used for
measuring, regulating or recording temperatures,
18
pH, acidity, water activity or other condition is
.
accurate, adequately maintained and adequate in
number for their designated uses (110.40f)?
Whether the plant assure the compressed air or
other gases mechanically introduced into food to
19
clean food-contact surfaces or equipment is treated
.
in such a way that food is not contaminated with
unlawful indirect food additives 110.40g?

Notes

Section-3 Points Scored Points Available %


Performance

Page 9 of 17
SECTION-4 –PROCESS CONTROLS (110.80)

Fully Satisfied Partly Satisfied Not Satisfied


N/A
5 3 0

Sl
. Checks Observations Rating
#
Does the plant have operations in receiving,
inspecting, transporting, segregations, preparing,
1. manufacturing, packaging and storing of food is
conducted as per adequate sanitation principles
(110.80)?
Does the plant have one or more individual
2. competent individual who looks after (supervise)
the overall sanitation of the plant (110.80)?
Does the plant have procedure to eliminate the food
that has been contaminated – rejection or if
3.
permissible any process to eliminate the
contamination (110.80)?
Are raw material procedures in place – inspected,
segregated, handled properly and stored in
4. 5/3/0
appropriate condition to protect contamination
110.80a1?.
Are raw material stored in the plant premises under
conditions that protects them against contamination
5. and infestation and quick deterioration? Are stores 5/3/0
and their doors and windows constructed to prevent
entrance of rodents 110.80a4?
Is water used for conveying raw materials, comply
with the gulf standards concerned with "Bottled and
6. un-bottled Drinking water" approved by 5/3/0
Standardization and Metrology Organization for
G.C.C. 110.80a1
Does the company purchase all materials under a
supplier’s guarantee or certification as per the
7.
examination of the materials to assure there is no
contamination 110.80a4?
Are the RM’s are stored in adequate required
condition (temperature & RH) and do the company
8.
have sufficient record to assure the monitoring of
the same to safeguard the RMs (110.80a5)
9. Are inspection and sorting done prior to 5/3/0
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

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materials are processed?
Are raw materials washed as needed to remove dust
10 or other contaminants? Is this water used for such
5/3/0
. purpose is recalculated unless suitably treated to
maintain it non hazardous for public health.
Frozen raw materials and other ingredients shall be
11 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?
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 5/3/0
.
contamination, deterioration, spoilage, or the
development of pathogenic micro organisms or
toxicity.
Are random samples drawn from processing line
13
and from the finished product to assure safety of 5/3/0
.
production?
Is packaging material containing any substance
causing objectionable organleptic changes in the
14
product, and is treated by a way that does not cause 5/3/0
.
toxicity or affect the foods with which they come
into contact.
Is packaging material a non- absorbent, tasteless
15
and odourless and shall assure convenient 5/3/0
.
protection of the product against contamination.
16 Is packaging carried out under suitable hygienic
5/3/0
. conditions?
Does the plant have effective measures to protect
against the inclusion of metal or other extraneous
17
material in food such as sieves, traps, magnets,
.
electronic metal detectors or other suitable effective
means (110.80 b8)
18 Are methods of preservation are to protect the
. product against contamination, infestation, disease
5/3/0
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, so that, when necessary, a 5/3/0
.
specified food lot which may have become
contaminated or unfit for the purpose of its use
shall be segregated.
Finished products are stored and transported under
conditions as to preclude its contamination or
20
proliferation of micro organisms. Is product 5/3/0
.
protected against deterioration or containers
damage?

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Are periodic inspection is carried out during
storage of finished product to ensure that the food
21
is fit for human consumption and that it complies 5/3/0
.
with the with the standard specifications of the
finished product .
Are FG store rooms are moisture free and air
22
conditioned and are refrigerated and is rodent proof 5/3/0
.
110.80b6?
Does the company use QC operation to assure the
23 quality of manufactured product in which the
5/3/0
. critical control points are identified and controlled
during manufacturing (110.80bi)
Do the company’s storage and transportation of
24
finished food is under condition that will protect
.
food against physical, chemical and microbial
D
contamination as well deterioration of food and the
container (110.93)?

Notes

Section-4 Points Scored Points Available %


Performance

Page 12 of 17
SECTION-5

Fully Satisfied Partly Satisfied Not Satisfied


N/A
5 3 0

CLEANING
Sl
. Checks Observations Rating
#
Cleaning regimes for equipment must be in place
1. and followed. Records to support this must be 5/3/0
available for review.
Cleaning regimes for floors, walls, drains etc must
2. be in place and followed. Records to support this 5/3/0
must be available for review.
3. Cleaning Effectiveness 5/3/0

Correct cleaning utensils for all cleaning purposes


4. must be available and used in the appropriate 5/3/0
manners and stored properly when not in use.
5. Correct cleaning-out-of-place equipment available. 5/3/0

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

Fogging regimes in place. Records to support this


7. 5/3/0
must be available for review.

PEST CONTROL

Sl
. Checks Observations Rating
#
Are there periodic controls on all outside pest
1. breeding places, as well as all inside harbouring 5/3/0
and hibernating spots?
Are floors, walls, bucket elevators, and conveyors
2. frequently inspected for detecting the presence of 5/3/0
insect secretions and eggs in crevices?
Are pest resistance substances used for rodents?
Are they used in a manner so that they are not
3. 5/3/0
leading to contamination of foods, and their toxicity
is low for humans?
4. Are contaminated equipments and utensils 5/3/0
thoroughly cleaned to remove pesticide residues

Page 13 of 17
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.
Are pesticides stored in locked rooms and are used
only for that purpose and dispensed and handled by
5. authorization, and through properly trained
personnel. Is extreme care is taken to avoid food
contamination.
Insect-o-cutters in correct position, operational and
6.
cleaned regularly.
7. Doors must be closed and door seals must be intact.

LABORATORY CONTROL

Sl.
Checks Observations Rating
#
1 Is each plant is having a special laboratory to
. carry out tests necessary to assure the safety of 5/3/0
the products.
Are official authorities, each according to its
2 duties and functions, are periodically taking
. samples representative of the production for 5/3/0
analysis purpose, to assure the safety of the
product and its compliance with the standards.
3
Is calibration of lab equipments used for testing is
. 5/3/0
done.
4 Are staffs in laboratory qualified to carry out the
. test required to make sure the product is safe and 5/3/0
is as per quality standards.

FOREIGN BODY CONTAMINATION

Sl.
Checks Observations Rating
#
Tightening of loose nuts/ screws in process
1. 5/3/0
equipments immediately after maintenance jobs.
Storage of Miscellaneous small engineering
2. items, screws, nuts, washers etc. in food 5/3/0
containers.
3. Use of Packaging material for drinking purposes. 5/3/0

Open containers of Ingredients, In- process


4. 5/3/0
materials and finished products.
Page 14 of 17
Inspection of process equipments and conveyor
5. 5/3/0
hoods for foreign body.
Inversion, cleaning of cans, bottles and other
6. 5/3/0
containers before filling.
Exposure of the bottles during production
7. stoppages. Exposed products to be discarded up 5/3/0
on resumption of production.
8. Condition of overhead pipes. 5/3/0

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

Presence of controlling system of knives in the


10. 5/3/0
departments.
Proper conveyor covers prior to filling section for
11. 5/3/0
all fillers
Cleaning of Inverter FB traps and identification
12. 5/3/0
of foreign bodies need to done and recorded.
A corrective action for identified foreign body is
13. 5/3/0
taken effectively.
Thorough weekly cleaning for Inverters
14. 5/3/0
performed regularly and records are maintained

WASTAGE MANAGEMENT

Fully Satisfied Partly Satisfied Not Satisfied


N/A
5 3 0

Sl.
Checks Observation Rating
#
Minimal levels of waste in the department at any
1. 5/3/0
time.
Procedures for managing, collecting and
2. disposing of waste in place and adherence to 5/3/0
procedures.
Proper containers for the collection and disposal
3. 5/3/0
of waste.
4. Cleanliness – Regime & actual practice. 5/3/0

MISCELLANEOUS

Sl.
Checks Rating
#
Crates and pallets must only be used for intended
1. 5/3/0
purpose.
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2. Packaging must only used for intended purpose. 5/3/0

All crates and pallets that enter department must


3. 5/3/0
be cleaned.
Hazardous materials must be stored away from
4. 5/3/0
raw materials and finished products.
Ingredient must be stored in sealed containers and
5. 5/3/0
labelled for traceability.

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

All risky / dangerous material / pipe lines


7. 5/3/0
properly tagged / protected
Is Mixing, Processing, Filling and Packing
8. department should be separated to reduce any
contamination from one section to another.
Notes

Section-5 Points Scored Points Available %


Performance

Page 16 of 17
GMP Audit Results Summary

Function or Location Audited By

Date of Audit Self – Audit or Independent


Independent

Section-1 Points Scored (a) Points Available (b) %


Personnel &
Personnel Practices

Section-2 Points Scored (a) Points Available (b) %


Building & Facilities

Section-3 Points Scored (a) Points Available (b) %


Equipment and
Utensils

Section-4 Points Scored (a) Points Available (b) %


Process Controls

Section-5 Points Scored (a) Points Available (b) %


Miscellaneous

Overall Points Scored (a) Points Available (b) %


Performance

Page 17 of 17