GMPs
GMPs
GMPs
Table of Contents:
1- Infrastructure:
The layout and design of all permanent and temporary building structures; maintenance of
surrounding environment; utilities program; new equipment release and management;
maintenance programs.
2- Employee Awareness:
Training for employee awareness and competency testing: GMPs; Food Safety; Personnel Hygiene
and Health.
3- Production Principles:
Supply management, storage, warehousing and transportation.
4- Production Environment:
Waste management, chemical control, sanitation program, pest control and environmental
monitoring.
6- Self-Assessment:
Internal auditing program, auditor qualifications and corrective actions.
1- Infrastructure:
Each facility must establish traffic patterns for product and personnel to minimize the
potential for product contamination.
رﺳﻣﺔ ﺗﺻﻣﯾم اﻟﺑﻧﯾﺔ اﻟﺗﺣﺗﯾﺔ ﻟﻠﻣﻧﺷﺎة اﻟﻐذاﺋﯾﺔ ﯾﺟب ان ﯾﺣدد ﻓﯾﮭﺎ ﻣﻣرات وﻣﺳﺎرات واﺗﺟﺎه ﺗﺣرك ﻛل ﻣن اﻟﻣواد
اﻟﺧﺎم اﻟﻣﺳﺗﺧدﻣﺔ وﺗواﺟد اﻟﻌﻣﺎل واﻟﻣﻧﺗﺞ اﻟﻧﮭﺎﺋﻲ وﻣﺳﺗﻠزﻣﺎت اﻻﻧﺗﺎج وﺗﺣدﯾد ﻛل ﻣﻛﺎن ﻋﻠﻲ اﻟﺧرﯾطﺔ ﻣﺛل اﻣﺎﻛن
.ﺗﻐﯾﯾر اﻟﻣﻼﺑس اﻟﻛﺎﻧﺗﯾن ﻣﻧﺎطق اﻟﺗدﺧﯾن اﻟﻣﻌﻣل اﻻﻣن اﻟﺣﻣﺎﻣﺎت وھﻛذا
1.2 Utilities:
All production sites must have an established program for the handling and use of
water, electricity/lighting, boilers/steam, gas and compressed air.
All clean rooms where open product is handled must have positive pressure to avoid
airborne contamination.
Potable water must be tested annually and comply with local regulation or WHO.
Treated, chlorinated and deionized water must comply with local regulations
regarding quality and microbiological require-mentis. Where applicable, back-flow
preventers must be in place.
Dead-end piping should be avoided, if in use, must be cleaned and monitored and
must be included in the environmental program. Steam (culinary water) supply used
for products or product surfaces must be potable and comply with local regulations
regarding quality and micro-biological requirements.
ﯾﺟب ان ﯾﻛون ھﻧﺎك ﺧرﯾطﺔ ﻟﻣﺳﺎرات اﻟﻣﯾﺎة ﺑﺎﻟﻣﻧﺷﺄة ﻋﻠﻲ ان ﺗﻛون ﻣﺳﺎر ﺣرﻛﮫ واﺗﺟﺎه اﻟﻣﯾﺎه ﻓﻲ اﺗﺟﺎه واﺣد
ﺣﺗﻲ ﻻﯾﺗم رﻛود ﻟﻠﻣﯾﺎة وﯾﺣدث ﺗﻠوث
1.2.3 Lighting
The lighting must be sufficient enough to maintain hygienic conditions. Fixtures must
be protected to prevent breakage. Bulbs must be safety coated or non-breakable.
1.3.2 Sanitation
Sanitation procedures must be defined by either the manufacturer or per a sanitation
validation program.
The frequency for re-validation and verification must be defined based on the
equipment, use, and manufacturer recommended frequency.
1.4 Maintenance:
All production sites must have an established Facility Preventive Maintenance
Program.
A facility inspection must be conducted at least annually and corrective actions must
be documented to support the FPM Program and food safety requirements.
The release must include a reconciliation of tools* used for the EPM.
Definitions
*Reconciliation of tools:
The maintenance responsible must account for all tools used during the PM or
temporary repair of equipment, assure that no tools remain behind and all tools are
returned to the appropriate maintenance storage location.
2- Employee Awareness :
Personnel performing work affecting the quality and food safety of our ingredients,
finished products and packaging must have the appropriate combination of education,
training and experience for their assigned tasks.
2.1.1 GMPs/Behaviour:
To protect food ingredients from contamination, protective apparel such as head, face,
hand, and arm coverings must be worn as appropriate to the duties performed.
Plain prescription glasses and medic alert identification* are allowed. Jewellery, visible
piercings and other loose items, including those in pockets above the waistline, must be
removed (plain wedding bands are allowed).
Only authorized personnel are allowed to enter those areas of the buildings and facilities
designated as limited access areas.
Each production employee must have access to a personal locker in a locker room.
Employees must maintain separation of personal and work related clothing and items.
Any person known or suspected to have an illness or open lesions that could impact food
safety (by either medical examination or supervisory observation) must be excluded from
direct contact with raw materials, packaging components, intermediates and finished
products until the condition is corrected or determined by competent personnel not to
jeopardize the safety or quality of the food ingredient.
Management must ensure that employees are trained at sufficient frequency to ensure
that employees remain familiar with applicable principles, at minimum once per year.
3- Production Principles:
3.1.1 Selection/Approval
All raw materials, traded goods, packaging suppliers and toll manufacturers must be
assessed and approved based on their ability to meet food safety and Corporate Social
Responsibility requirements and specifications.
3.1.4 Evaluation/Audit
All direct material suppliers (toll manufacturers, traded goods, raw materials and primary
packaging) must be approved prior to supply or use and there after reevaluated at
minimum every five years. All critical (high risk) direct material suppliers must be audited
and approved prior to supply or use and thereafter re-approved based on audit every
three years.
3.1.5 Documentation
Documentation required for approval, risk assessment, evaluation and/or audit of a direct
material supplier must be maintained and renewed throughout the approval period of the
supplier by the assigned responsible function.
3.2.6 Transportation
All transportation companies must comply with local transportation regulations.
Each company must sign a food safety agreement accepting our food safety requirements.
Identify steps in their operations which are critical to the safety of food;
Specific Process Steps Chilling, thermal processing, irradiation, drying, chemical , vacuum
or MAP
Stocks of raw materials and ingredients should be subjected to effective stock rotation
5 Water
In contact with Food
As an Ingredient
Potable Water Should be as specified in WHO Guidelines for Drinking Water Quality or
Water of Higher Standard
Records retained for a period that exceeds the shelf-life of the product
Documentation can enhance the credibility and effectiveness of the food safety control
system.
4- Production Environment:
Storage of collected waste must be stored in a designated area for collective disposal.
Removal and destruction must be carried out by an approved disposal contractor. Records
of destruction shall be retained. Hazardous materials must be stored and secured prior to
disposal.
4.1.3 Drains/Drainage
Waste drains must not pass over process lines unless properly protected, e.g. drip pans.
Open waste drains must be of appropriate design for the location to avoid contamination
and must not flow to a clean area.
Each production site must have a program for the purchase, storage and use of food grade
and non-food grade chemicals, including boiler chemicals.
4.2.2 Cleaning
Cleaning chemicals must be for food-grade use, labeled, secured, access controlled and
stored separately when not in use per manufacturer’s SDS.
Each production site must validate and monitor cleaning and sanitation processes (facility,
equipment, tools and utensils).
4.3.2 Documentation
Each production area and related equipment must have a documented sanitation
procedure identifying frequency, chemical used, application method and visual inspection
prior to swabbing or equivalent.
4.3.3 Verification
An ATP swabbing plan or equivalent must be established for each production area and
related equipment. Verification frequency and results must be documented.
The program must include the frequency for testing and monitoring all zones.
The pest control program must be documented, including frequency of methods by target
areas, control procedures and documented training. The chemicals used must be approved
for use and documented. Poison must not be used inside the premises.
:طرق اﻟﻣﻛﺎﻓﺣﮫ
اﻻھﺗﻣﺎم ﺑﺎﻟزراﻋﮫ واﻟﻣﺳﺎﺣﺎت اﻟﺧﺿراء اﻟﺗﻲ ﺗﻛﺎﻓﺢ اﻟﺣﺷرات واﻟﻘوارض.
اﺳﺗﺧدام اﻟزﻟط واﻟرﻣل اﻣﺎم اﻟﻣﻧﺷﺎءه ﺑﺣﯾث ﯾﻛون ﺧط دﻓﺎع ﺿد اﻟﻘوارض واﻻﻓﺎﻋﻲ.
اﺳﺗﺧدام اﻟﻣﺑﯾدات اﻟﺣﺷرﯾﮫ ااﻟﻐﯾر ﺿﺎره وﻟﯾﺳت ﻣﺳﻣﻣﮫ ﻣﻊ ﺑﻌض اﻟﻛﯾﻣﺎوﯾﺎت اﻟﺗﻲ ﺗﺿﺎف ﻓﻲ اﻟﻣﺟﺎري ﻟﻠﻣﻛﺎﻓﺣﮫ.
اﺳﺗﺧدام ﺳﺗﺎﺋر اﻟﮭواء اﻣﺎم اﺑواب اﻟﻣﻧﺷﺎءه وﺻﺎﻻت اﻻﻧﺗﺎج ﻟﻣﻧﻊ دﺧول اﻟﺣﺷرات واﻟذﺑﺎب.
اﺳﺗﺧدام اﻟﻣﺻﺎﺋد ﻟﻠﻔﺋران.
اﺿﺎءه زرﻗﺎء وﺻواﻋق ﻟﻠذﺑﺎب.
ﻣﺻﺎﺋد زﺑﺎب ﻟون اﺻﻔر ﯾﺟذب اﻟذﺑﺎب واﺣﺑﺎل ﻋﻠﯾﮭﺎ ﺳﻣﻎ زرﻗﺎء او ﺻﻔراء ﻟﺟذب اﻟذﺑﺎب واﺳﺗﺧدام ﻣراوح.
رش ﺑدره ورش ﺳﺎﺋل ﻟﻠﺻراﺻﯾر واﻟﺣﺷرات اﻟزاﺣﻔﮫ ﺑﻌد اﻧﺗﮭﺎء اﻟﻌﻣل وﯾوﺿﻊ اﺳﺑوﻋﯾﺎ.
ﻏﻠق اﻻﺑواب واﻟﺷﺑﺎﺑﯾك ﺑﺎﻻﺳﻼك وﻗطﻊ ﺟﻠد ﻋﻠﻲ اﻻﺑواب ﻟﻣﻧﻊ دﺧول اﻟﺣﺷرات واﻟﻘوارض.
Always Remember
1 fly leads to 900
1 cockroach leads to 30 -40
1 moth leads to 400
1 beetle leads to 375
1 rodent leads to 30
Weekly stock counts are required for all these types of blocked products and must be
documented.
5.3.1 Traceability
All product lots, including rework, must be traceable back to the supply (one step up, one
step down).
Internal mock traceability must be conducted annually per product division per plant.
Food Traceability
Traceability is a risk-management tool which allows food business operators or authorities
to withdraw or recall products which have been identified as unsafe.
6.1 Auditing:
Each production site must have an established internal auditing program against the
appropriate standard, scheduled frequency, auditor qualifications and corrective actions.
The program must cover all certificate(s) requirements including, but not limited to, GMP,
HACCP, sanitation, maintenance, equipment release etc. Each audit must be supervised by a
lead auditor.
It is recommended that the audit program is based on annual audit activities even if the
certificates have a longer lifetime.
Each internal auditor must have prior experience and or internal auditor training.
CA cycle should be completed within 120 days. If exceeding 120 days, the plant manager
must submit an action plan.
Thanks a lot my friends