* Fundamental Requirement

Non Fundamental Requirement / GMP / Audit on Production Facilities

Non Fundamental Req / Rec., Sys.,&Docs / Audit on Records/Documents / Systems
Both

‫مقدمى الخدمات الخارجية و تعليمات و اشتراطات‬

‫تكليف رسمى موثق للمسئول عن حركة الزوار و‬

‫سجالت الفحص الدورى للمبات ووسائل اإلنارة و‬

‫خريطة تفصيلية لخطوط الصرف و عالقتها بأماكن‬
‫ برنامج اإلشتراطات األساسية‬+ ‫تقييم المخاطر‬

‫األنشطة مرفق بال‬/‫اجراءات تنظيم حركة األفراد‬

HC & ‫تقييم مخاطر التلوث الغذائى الخاص بال‬

‫اعتمادات و تسجيل المصنع بالجهات الرسمية‬
PRP Check List + After Maintenance food

‫ و سجالت تدورية تغييرها‬HC ‫بحطوط انتاج ال‬

‫خريطة تفصيلية للمصنع موضحة حركة جميع‬

‫سجالت الفحص الدورى لفالتر الهواء الخاصة‬

SOI / Requirement

‫ فى حالة ذلك‬Zones ‫األنشطة و ال‬

‫توافر أغطية الحماية الخاصة بها‬

safety W.I. + Sanitation PRGR

‫الخاصين باألمن و األمان بالموقع‬

‫برنامج األمن و األمان بالموقع‬

Site Condition Check

‫حسب التشريعات القانونية‬

‫حسب تقييم المخاطر‬

‫المعدات و الماكينات‬
Ambient HC zones
Process Flow
Procedure

4.1.1 To put measures into place to prevent

External Standards

contamination by considering local activities

& site environment and to protect the site
X
( Review in response to any changes)

4.1.2 Ext area (traffic routes &

grassed/planted areas) shall b regularely
maintained in good orders and under site
X
control
4.1

4.1.3 The building fabric & utilities ( bird

nests, sealing gaps around pipes,…etc)
X
4.2.1 A Documented risk assessment of
the security arrangement and potential
risks to the product from any deliberate X
attempt to inflict contamination _ assessment
to incl.:
4.2.2 ASite security Procedure incl. a
visitor/contractor reporting sys. & Staff
4.2 Security

awareness/training & measures to ensure X

access of only authorised personnel to
stores & production area

4.2.3 Ext.storage tanks,silos and any intake

pipes with an external opening shall be X
locked

4.2.4 The site shall be registered w/ the

required legislation according to the X
appropriate authorities

4.3.1 A map of the sites which designates

zones ( HR, HC, Ambiant HC, LR; enclosed
product areas & non-product areas )_ X
Zonning shall be taken in consideration
when determining the PRP
 4.3.2 Site map shall define: 1- Acess points
for personnel 2- acess points for
raw&pack 3- routes of movement for
personnel 4 of movements for raw&pack
5- routes for waste removal 6- routes for
X
rework movement 7- location of any staff
facilities( canteens,toilets,...etc)
8- Production process flow

4.3.3 A nominated person responsibility of

contractors/visitors/drivers working in product
4.3 LayOut, Product Flow and Segregation

processing or storage areas & they shall be X

made aware of " Procedures for Access &
potential hazards/contamination of product"

4.3.4 Procedures of "the movement of

personnel" asides with the process flow _ in
place to minimise the risk of contamination of raw,
X
pack, product or rework

4.3.5 Physical Segregation between HR

areas and other areas of the site, which takes
into account, the flow of products, air flow X
and quality, equipments, personnel
movement ….etc )

4.3.6 Physical Segregation between HC

areas and other areas of the site, which takes
into account, the flow of products, air flow
and quality, equipments, personnel
movement ….etc )……Where no possibility X X
for physical segregation, a Documented
*

Risk Assessment of the potential for X-

Contam and effective validated processes
shall be in place

4.3.7 in case Ambient HC areas, a Documented

Risk Assessment for X-Contam w/ pathogens,
which consider the potential sources of
microbiological contam _ incl. :(See Cell
X
comment) PLUS an effective processes to
protect final product

4.3.8 A sufficient work space and storage

capacity to enable opeations to be carried out X
properly under hygienic conditions

4.3.9 A design of temporary structures to

be constructed during refurbishment or X
extensions

4.4.1 Walls finishing material to prevent

accumulation of dirt and facilitate cleaning
X

4.4.2 Floors shall b suiatble hard wearing

which meets the demands of the process and X
withstand cleaning materials and methods
and Storage Areas
Building fabric, Raw Material handling, Preparation, Processing, Packing and Storage Areas 4.4.3 Machinery and piping shall be
designed and arranged so that drainage &
process waste water goes direclty to drains_
in case significant amount of water used
X
while direct piping to drains not
possible_floors shall have adequate falls

4.4.4 A map of drains shows the direction of

flows and location of equipments fitted which
shall not present a risk of contamination by a
X
back-up of waste water _ in case HR & HC

4.4.5 Ceilings shall b constructed to prevent

product contamination
X

4.4.6 In case of suspended ceiling,

adequate access shall be there to facilitate X
inspection for pest activity

4.4.7 Windows and roof glazing for

ventilation purpose shall be adequately X
screened to prevent the ingress of pests

4.4.8 Glass windows shall be protected by

means of anticrubmling transparent stickers
X

4.4.9 External doors and docks_ adequately

proofed w/ suitable precautions to prevent
pest ingress& those could be opened to X
product area SHALL NOT be opened during
production periods

4.4.10 Suitable and Suffient lighting to allow

correct operation/inspection/cleaning
X

4.4.11 Bulbs&Stripe lights incl. those of

elec. Fly killer devices shall be adequately
fully protected + A monitoring procedures
X X
in place
4.4

4.4.12 Ventilation/extraction sys. Provided in

storage & processing areas "" type """ is
based to Risk assess to prevent
X
condensation or excessive dust

4.4.13 Air filters for HR_ Specs of filters,

source of air and frequency of air changes
shall be documented ( decided based on risk
X X
assessment)

4.5.1 Water used as a raw materialshall be

ies- Water, Ice, Air and other Gases

potable at point of use according to

applicable legislation_ Chemical &
Microbiological analysis. Sampling point,
Scope of test, frequency of analysis shall be
based on risk & on source of water, on site
storage and distribution facilities & previous
sample history
Utilities- Water, Ice, Air and ot
4.5.2 An up-to-date schematic diagram of
the water distribution system on site, and
shall be used of water sampling and
management of water quality

4.5.3 Where legislation permits the use on

non-potable water for initial product cleaning (
ex Fish) _ water shall meet the designated
legal requiremnts

4.5.4 Compressed air or steam or any

4.5

gases used directly in contact w/ product X

shall be filtered & monitored

4.6.1 Equip. shall be constructed of

Equipment

appropriate materials///design and placement X

allow effective cleaning process

4.6.2 Equip. in direct contact w/ food should

meet legal requirements ( to be food X
4.6

grade..incl. grease used in machinery)

4.7.1 A Documented planned

maintenance schedule / monitorng sys.
( maintenance requirement is defined when
commissionning a new equip.)

4.7.2 Equipment shall be inspected at a

predetermined intervals _ A Documented
inspection results & C.A.

4.7.3 When temporary repairs are made,

temporary control measures shall be in
place to ensure product is not jeopardised to
4.7 Maintenance

risk of contamination

4.7.4 A Hygiene clearance Procedure for

the cleaning operations post to
maintenance, shall be documented

4.7.5 Maintenance activities in HR&HC

areas shalll respect the segregation
requirements ( tools to be dedicated/retaied
X
in area)

4.7.6 Material used for maintenance,

lubrication oil,…shall be food grade and of a X
known allergen status

4.7.7 Measure Controls shall be in place

to prevent engineering debris from being X
transferred to production or storages

4.8.1 Designated changing facilities shall

be provided for all personnel (staff,
visitors/contractors) _ facilities to allow direct
access to production / packing/storage w/o
resources to ext. area _ where not possible _
X
a risk assess & A Procedures shall be in
place ( cleaning facilities for footware is a
must)
 4.8.2 Storage facilities of suffecient size to
accommodate personnel items
X

4.8.2 Storage facilities of suffecient size to

accommodate personnel items
X
4.8 Staff Facilities

4.8.4 Changing facilities / protective clothing

designated to HR area _shall meet the
following(comment) : plus a prgr of env. X
Monitoring shall be established to assess the
effectiveness of footwear controls

4.8.5 Changing facilities / protective clothing

designated to HC area ( mainly same and X
distinctive from LR

4.8.6 Hand washing facilities conditions

(comment) :
X

4.8.7 Toilets conditions (comment) X

4.8.8 Smoking areas conditions (comment) X

4.8.9 Food brought by staff conditions

(comment)
X

4.8.10 in case catering facilities are provided _ a

control procedures to prevent contam of provided
products/meals & to introduce allergenic material
X
to the site

4.9.1 Chemical Control

amination control_ incl. Raw Material handling; Preparation; Processing, Packing and Storage area

4.9.1.1 A processess shall b in place to manage

the use, storage & handling of non-food
chemicals _ incl. as a minimum
(comment) :

4.9.1.2 A procedure to control/ prevent the risk

of contam. by the strongly scented or taint forming
materials, which have to b used for building work

4.9.2 Metal Control

4.9.2.1 A documented policy in place for the
control of used of metals _ incl. as a must a
record of inspection for damage & investigation of
lost items ( PROHIBTION of the use of Snap-off-
riate procedures/facilities to control chem.& Physical contam)

blades)
4.9.2.2 Purchase of packaging w/ staples or else
foreign materials shall be avoided (also paper
clips or drawing pins are PROHIBITED inside
X
production area)
4.9.3 Glass, Brittle Plastic, ceramics and
similar materials

4.9.3.1 Glass and other brittle materials either

excluded or protected by means of anticrubmling X
transparent stickers

4.9.3.2 A Documented Procedures for handling

glass and other brittle materials (other than
product pacakging) _ incl. as a min (comment):

4.9.3.3 A Documented procedures detailing

the action to be taken in case of breakage
incidences, incl.: (comment)
 ( Appropriate procedures/facilitie
4.9 Chemical and Physical product contamination control_ incl. Ra
4.9.4 Products packed into Glass or other
Brittle containers
4.9.4.1 Storage of conatiners shall be segregated
from raw & pack
X

4.9.4.2 A Documented Procedure to manage the

control of container breakages between the stage
of cleaning/inspection until the containers final
closure _ incl. _as a min_instruction : ( comment )

4.9.4.3 Records of all breackage incidents shall

be maintained and when no breakage incidents
occurred _ shall also be recorded
4.9.5 Wood

4.9.5.1 wood is prohibited in product areas

except where there it is a process req. _ then
there should be a monitoring process to
X
ensure it is free of damage or splinters

4.10.1 Foreign-Body detection and

Removal Equipment

4.10.1.1 A Documented assessment in

association with the HACCP study shall be
carried out on each production process to
identify the potential use to detect / remove
foreign body contam. ( such …comment)

4.10.1.2 Type, location, sensitivity of the

detection/removal method shall be
documented & the location effect or any else
factors affect the sensitivity shall be be
justified nd validaed and documented

4.10.1.3 Frequeny of the testing of the

detection/removal sys shall be defined ALSO
the site ability to identify,hold and prevent the
release of any affected materials in case of
the equip. fail
4__Site Standards

4.10.1.4 When foreign material detected or

removed _ the source of it shall be
investigated & preventive actions shall be in
place to prevent re-occurrence of contam. of
it

4.10.2 Filters & Sieves

4.10.2.1 Shall be of a specified mesh size or

guage (based on risk assess to provide the
max protection) & examination/investigation
of the removed/retained foreign materials by
the system_ Shall be recorded
ment
 4.10.2.2 A documented inspection/test at
a frequency based on Risk assess._
Records shall be kept _ in case of defective
filters or sieves are identified, this shall be
recorded in parallel with the planned
appropriate actions
4.10 Foreign- Body detection and Removal Equipment

4.10.3 Metal detectors and X-Ray

equipment

4.10.3.1 Existance of metal detection is A MUST

unless a DOCUMENTED risk assessment &
Justification demonstrates this does not improve
the protection of final products from metal X
contamination (absence of metal detection
normaly be based on the use of an alternative or
more effective detection sys.

4.10.3.2 the metal detection or X-Ray shall

incorporate EITHER an automatic rejection device
OR a belt stop sys w/ an alarm where the product
cannot be auto rejected (ex v. large packs) OR in-
X
line detectors to identify the location of the
contaminant product

4.10.3.3 A Documented/Implemented
Procedures for the Operation and Testing of the
metal detection system _ incl. as a min
( comment)

4.10.3.4 Metal detectors checking procedures

shall be based on good practice and authorized
personnel & shall incl. as minimum : (comment) _
in addition : 1- M.D. incorporated on conveyors,
test pieces to be placed as close as possible to X
the center of the M.D. aperture 2- test pieces
shall be placed in the product flow in case of in-
line M.D. 3- Validation of correct timing of the
rejection sys. shall be implemeted / recorded

4.10.3.5 A C.A. & Reporting Procedure of the

event of testing procedure identifying any failure
of the foreign body detector; shall be implemented
and includes a combination of isolation,
quarantining and re-inspection of all product
produced since the last successful test

4.10.4 Magnets

4.10.4.1 Type, strength, location shall be

documented plus A Documented procedure for
the inspection, cleaning, strength testing/checks
_& maintained records

4.10.5 Optical Sorting Equipment

4.10.5.1 Each unit shall be checked in

accordance with the manufacturer s instructions_
checks shall be documented

4.10.6 Container cleanliness__Glass

Jars,Cans and other Rigid containers
 4.10.6.1 A Procedure shall be implemented to
minimise foreign body contam. originating with the
packaging containers ( Jars,cans, …) _comment

4.10.6.2 Records of checks of the effectiveness

of the containers cleaning equipments during
each production & in case system incorporates a
rejection system for dirty/damaged then the
checks shall include effectiveness detection &
rejection

4.11.1 The premises and Equipment shall be

maintained in a clean and hygienic condition
X

4.11.2 A Documented cleaning procedures

shall be maintained for the building, plant,
processing equip., food contact surfaces &
environmental cleaning in HR & HC areas _ incl.
as a min : (comment) NOTE : Cleaning
Procedures are a part of the PRP plan

Very Important clause 4.11.3 Definitions

of limitis of acceptable cleaning performance of
food contact surfaces and processing equi. and
environmental cleaning in HR & HC __this shall
be based on potential
hazards( microbio,allergen,physical) ___
acceptable level definition also
(comment) ......Cleaning/Desinfection
Procedures and Frequency shall be validated
and records maintained & Risk of chemical
residues on food contact surfaces shoud be
considred as well

4.11.4 When access to large equip. or

dismanteling is required for cleaning process
House Keeping & Hygiene

_ this needs to be scheduled for non-

production periods & engineering support
X
shall be provided and planned ( Records
shall be maintained)

4.11.5 Check of cleanliness of equip before

release back into production
( visual,analytical & microbio) shall be
recorded & used to identify trends of
cleaning performance

4.11.6 Cleaning Equip conditions:

1- hygienically designed and fit for purpose
* 4.11

2- color coded 3- cleaned and stored in X

hyg. Manner 4- those for HR&HC areas are
distinctive

4.11.7 CIP (Cleaning in Place)

4.11.7.1 Shall be monitored and maintained

to ensure effective operation
 4.11.7.2 A Schematic diagram of the layout of
the CIP sys. Incl. process piping circuits PLUS an
Inspection / validation report that: ( comment)
PLUS A log of changes to the CIP system &
system revalidation in case of alterations or
additions

4.11.7.3 Validation records of the CIP

process parameters (time,detergent
concentration, flow rate, temperature,
appropriate removal of target hazards ex.
_soil/allergen/vegetative microorganism/spores_ CIP
Process Verification shall be undertaken by
analysis of rinse waters and/or 1st product on the
line throught the presence of cleaning fluids by
ATP testing .....Detergent tanks & recovered
post-rinse solutions & filters( see comment)

4.12.1 Waste disposals shall be managed in

accordance w/ legal requirements _ where
licensing is required by law for the removal of
4.12 Waste / Waste Disposal

waste, then a contract w/ a licensed contractors

shall be available for audit

4.12.2 External waste collection containers &

those of facilities waste shall be : clearly
identified//designed for ease of use and effective
cleanining//well maintained and
X
disinfected//emptied at appropriate frequency
//well covered

4.12.3 in case, Unsafe waste product or

substandards trademarked product (2nd degree)
_ transferred to 3rd party for disposal _ then he
should provide license and accurate records of
the qty. and specs of collected lot for disposal

4.13.1 Surplus customer-branded products shall

4.13 Management of surplus food &

be disposed according to customer requirements

& brand names shall be removed from packs
under the factory responsibility
products for animal feed

4.13.2 Where customer brand owner product

which do not meet specs are sold as 2nd degree
_ shall be w/ customer approval of the brand
owner _ A Documented / Implemented
processess that product fit for consumption and
meet legal req.

4.13.3 Downgraded/surplus products intended

for animal feed shall be segregated from waste
and protected from contam. During storage and X
managed in accordance w/ relevant legislative
requirements

4.14.1 An Effective Preventive Pest

Control/Management Program to: 1) minimise
the risk of infestation of pests 2) to respond to
any issues by the available appropriate resources
…. Records shall be maintained
 4.14.2 The frequency of inspection shall be
determined based on risk assessment , the Pest
Control Service shall be either by a competent
approved service provider ( service scope /
activities clearly defined in the service contract )
OR by a trained staff w/ sufficient knowlege
( review 4.14.3 for conditions)

4.14.3 In case site undertakes its own pest

control _ the following shall be demostrated :
( comment)

4.14.4 Pest control docs and records shall be

maintained _ incl. as min:

4.14.5 Bait stations or other rodent control

devices shall be appropriately located to prevent
contam risk _ Toxic rodent baits shall not be used
in production/storage areas ONLY IN CASE of X
Pest Control

treating an active infestation ….Any missing bait

stations shall be recorded / reviewed /
investigated

4.14.6 Fly killing devices and Pheromone traps

shall be correctly sited with zero risk of insects
being expelled from the device to contaminate
X
material/product
4.14

4.14.7 In the event of infestation or evidence of

pest activity _ Immediate action shall be taken to
identify " At Risk Product" and shall be subjected
to " Non-Conforming product Procedure"

4.14.8 Records of regular pest control inspection

& hygiene recommendation shall be the
responsibility of the site even in case of
outsource service provider & shall be maintained

4.14.9 An in-depth Pest Control Survey shall be

undertaken at a frequency based on risk assess
by a pest control expert to review the measures
in place suitability _ the time of survey should
allow access to equipment for deep inspection

4.14.10 Results of pest control inspections shall

be assessed and analysed for trends on a regular
basis_ the analysis shall be used as a base for
improving the pest control procedures ( ex. No. of
flys on sticky rods at certain period ….)

4.14.11 Employees shall understand the signs of

pest activity and report any evidence to a X
designated manager
 4.15.1 A Documented Implemented
Procedures to maintain product safety and
quality during storage _ incl.: 1- Managing
chilled/frozen product transfer between
temperature controlled areas 2- segregation of X
products to avoid x-contam (phys,micro,aller, or
taint uptake) 3- Off floor & away of wall
condition 4- Specific/appropriate handling &
stacking of products

4.15.2 Packaging will be stored separately from

raw materials *** Part used packing shall be
Storage Facilities

protected from contam and clearly defined before

being returned to storage to maintain X
treceability( w/ same withdrawal patch no.)
***Obsolete packaging shall be stored segregated
and labeled to avoid accidental use

4.15.3 For the temperature controlled storage,

temperature recording equip. w/ alarm shall be
fitted OR a manual recording check system on
at least 4 hours basis or the appropriate X
frequency which allow the intervention before the
4.15

product temperature reaches the limits for

safety/quality/legality

4.15.4 Where controlled atmosphere storage is

required _ Conditions shall be specified /
defined & documented _ Rocords of control
shall be maintained

4.15.5 Where storage outside is obligatory,

items shall be protected and checked before
being brought into the factory

4.15.6 Correct stock rotation of raw material /

pack/ final product in accordance w/ FIFO or X
FEFO

4.16.1 A Documented procedures for loading

_ incl. as min : 1) controlling temperature of
loading dock area 2) use of covered bays for
vehicle loading or unloading 3) securing loads
on pallets 4) inspection of loads prior to dispatch

4.16.2 Inpection log of vehicles/containers prior

to loading_ incl.: 1) Cleanliness 2) Odours free
3) suitable conditions guarantee safety of
product during transit 3) well locked and sealed
and only authorised personnel has the right to
unlock after loading ( this could be included in
procedure of loading 4.16.1)
Dispatch & Transport

4.16.3 Transport vehicles/containers shall be

equiped w/ temperature data-logging devices
which can be interrogated to confirm time/temp
condition during transit _ Records shall be
maintained per each loaded patch
4.16
Dispatch & Trans
4.16.4 A documented Procedure of
cleaning ;maintenance and inspecting of
Equipment & Vehicles used for loading/unloading
_ Records per each load/unload shall be
maintained
4.16

4.16.5 A documented Procedure for the

transport of Product; incl.: 1) any restrictions on
the use of mixed loads 2) requirements for the
security of products during transit, particularly
when vehicles are parked and unattended 3)
Clear instructions in case of vehicles
breakdown/accident or failure of refrigeration
systems

4.16.6 When a 3rd party contractor is

employed_ EITHER shall be certified to the BRC
Global Standard for Storage and Distribution or
similar GFSI recognised scheme OR all
requirements in clause 4.16 shall be defined in
the contract and verified
 ‫تقييم المخاطر الخاص بالمياه المستخدمة فى‬
‫التصنيع و برنامج التحاليل الكيميائىة و البيولوجية و‬
‫نتائجها ‪ +‬دياجرام مصادر المياه موضح عليه نقاط‬
‫أخذ العينات‬

‫تحاليل إثبات تطابق المياه غير القابلة للشرب‬

‫( فى حالة اتاحة استعمالها) للقوانين و‬
‫التشريعات‬
‫خصائص ‪ MSDS /‬المواد التصنيعية المالمسة‬
‫للمنتج كونها " ‪ "Food Grade‬و من مصدر‬
‫‪NonAlleric‬‬
‫اجراء الصيانة الدورية و سجالت الفحص الدورى‬
‫تشمل ال ‪ + C A‬حدود التحكم ضد تلوث المنتج‬
‫فى حاالت الصيانة غير المخططة‬

‫اجراء التطهير للمعدات عقب الصيانة‬

‫اجراء حركة العاملين‪/‬الزوار‪ /‬مقدمى الخدمة بعد‬

‫عملية التعقيم لدخول صاالت االنتاج فى حالة‬
‫عدم وجود مدخل مباشر من منطقة التعقيم الى‬
‫االنتاج‬

‫تعليمات‪ /‬خطوات‪/‬الترتيب السليم للتعقيم و‬

‫االرتداء قبل دخول منطقة ال ‪HR & HC‬‬

‫اجراء التحكم فى تداول و تخزين الكيماويات ‪+‬‬

‫قائمة بالمعتمدة ‪MSDS /‬‬
‫سياسة التحكم فى المواد المعدنية داخل الموقع‬
‫سياسة التحكم فى الزجاج و قائمة حصر بأماكنه‬
‫المحددة حسب تقييم المخاطر ‪ +‬اإلجراء المتبع‬
‫فى حوادث الكسر‬

‫سياسة التحكم فى مواد التعبئة الزجاجية من‬

‫مرحلة التعقيم حتى تعبئة المنتج النهائى ‪++‬‬
‫سجال حصر حاالت الكسر‬

‫تقييم مخاطر مبنى على خطة الهاسب لتحديد‬

‫نوع الكاشف عن المعادن و خصائصه و درجة‬
‫حساسيته و العوامل المؤثرة عليها ‪ +++‬سجالت‬
‫أو تقييم مخاطر‬ ‫التحقق من كال من‬
‫يثبت عدم الحاجة إلستخدام كاشف‬
‫معادن‬

‫دورية اختبار و التحقق من كاشف المعادن "‬

‫محددة و موثقة " ‪ ++‬إجراء التحكم فى المنتج‬
‫فى حالة ثبوت ‪Equip Fail‬‬
X
X

X
X

X
X

X
X