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GMPs

The document outlines Good Manufacturing Practices (GMPs) for food safety, detailing infrastructure requirements, employee training, production principles, and environmental controls. It emphasizes the importance of maintaining hygienic conditions, proper waste management, and compliance with food safety regulations. Additionally, it includes guidelines for employee awareness, supply management, and the handling of chemicals and equipment to prevent contamination and ensure product quality.

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Mahmoud Reda
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0% found this document useful (0 votes)
0 views16 pages

GMPs

The document outlines Good Manufacturing Practices (GMPs) for food safety, detailing infrastructure requirements, employee training, production principles, and environmental controls. It emphasizes the importance of maintaining hygienic conditions, proper waste management, and compliance with food safety regulations. Additionally, it includes guidelines for employee awareness, supply management, and the handling of chemicals and equipment to prevent contamination and ensure product quality.

Uploaded by

Mahmoud Reda
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Good Manufacturing Practices

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.

5- Food Safety and Food Security:


Programs for food safety, control of non-conformities, food security and food defence.

6- Self-Assessment:
Internal auditing program, auditor qualifications and corrective actions.

1- Infrastructure:

1.1. Layout of Premises and Workspace


Each production site must establish a program that monitors the external and internal
building structure including floors, walls and ceilings.

The program must include environment/vegetation controls, perimeter restrictions,


parking lot maintenance, control of standing water and potential contaminations from
the local environment (air, water, chemicals).

The program must include temporary structures.

1.1.1 Exterior Controls


Each facility must maintain the building and building perimeter to avoid any potential
for product contamination from the local environment.
1.1.2 Interior Layout
Each facility must maintain the walls, ceilings and floors to prevent potential
contamination.

Each facility must establish traffic patterns for product and personnel to minimize the
potential for product contamination.

1.1.3 Laboratory Layout


All laboratories must be separated from production and must have restricted access.
Microbiology laboratories must not open directly into production.

1.1.4 Temporary Structures


Prior to release for use, a risk assessment must be conducted, appropriate controls
identified and applied.

‫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.

The program must include the monitoring, maintenance and documentation.

1.2.1 Air Handling:


Heating, ventilation and air conditioning, positive/negative pressure rooms, clean
rooms*, filters, ventilation, testing of air, exterior air intake, etc. if applicable, must be
monitored and recorded.

All clean rooms where open product is handled must have positive pressure to avoid
airborne contamination.

1.2.2 Water Usage


Potable and non-potable water usage must be monitored to minimize contamination
risk.

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.

Each facility must have a glass breakage procedure.

1.2.4 Gas/Compressed Air


Oil free compressors are preferred; if not applicable oil must be food grade** or oil
should not come in contact with the air.

The compressor systems must be maintained to prevent contamination per the


Preventive Maintenance (PM) Program.

1.2.5 Boiler Chemicals


Boiler chemicals must be approved food-grade chemicals per local regulation.
The chemicals must be stored separately; see section on chemical control.

1.3 New Equipment:


All new equipment must be selected based on food grade requirements and
performance.

Validated sanitation procedures, preventive/corrective maintenance must be


established for all new equipment prior to release to production.

This includes measuring and monitoring equipment.

1.3.1 Equipment Design


Equipment must be of hygienic design with approved food contact surfaces*.

1.3.2 Sanitation
Sanitation procedures must be defined by either the manufacturer or per a sanitation
validation program.

1.3.3 Preventive Maintenance (PM)


A Preventive Maintenance (PM) Program must be established for all equipment;

1.3.4 Measuring and Monitoring Equipment


Equipment, including scales, that measures or monitors quality or food safety of
related processes or products, including laboratory equipment, must have a
documented validation, verification and/or calibration schedule established**.
Scales must be calibrated at minimum annually or per local requirement.

The frequency for re-validation and verification must be defined based on the
equipment, use, and manufacturer recommended frequency.

1.3.5 New Equipment Release


The corporate new equipment release form must be used for release to production
and filed with supporting equipment documentation.

1.4 Maintenance:
All production sites must have an established Facility Preventive Maintenance
Program.

Each production site must have an established preventive/corrective maintenance


program, temporary repairs procedure, reconciliation of tools/utensils and release to
production.

1.4.1 Facility Preventive Maintenance


A Facility Preventive Maintenance (FPM) Program must be established for the
maintenance of the building, exterior and interior, at a required frequency based on
the facility, age and environmental conditions.

A facility inspection must be conducted at least annually and corrective actions must
be documented to support the FPM Program and food safety requirements.

1.4.2 Equipment Preventative Maintenance


An Equipment Preventive Maintenance (EPM) Program must be established for All
food contact, monitoring and measuring equipment.

An EPM Program, as defined by the manufacturer or maintenance/engineering


department, must be established for all product related equipment that may have an
impact on quality and food safety.

The program must include frequency, replacement inventory requirements, release


requirements for preventive and corrective maintenance and allowable temporary
repairs based on the EPM criteria per equipment.

The release must include a reconciliation of tools* used for the EPM.

1.4.3 Temporary Repairs


Temporary repairs must follow release-to-production criteria per equipment.

Temporary repairs of the facility must follow release criteria.


A description of the repair, a risk assessment and corrective action must be
documented.
The release must include a reconciliation of tools used for the repair.

1.4.4 Maintenance Personnel Training


Authorized maintenance personnel must be trained or licensed to perform in the
maintenance and technical areas.

Training records must be documented and available for review.

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.

All employees must be trained in GMPs and food safety.

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.

2.1.2 Personnel Hygiene/ Health:


Hand washing stations must be available in production areas, appropriate clothing/shoes
must be worn, and designated smoking and/or eating areas must separate from
production and storage areas, health assessments must be conducted due to location
regulations.

. Personnel must practice good sanitation and health habits.

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.

2.1.3 Training and Testing for Competency:


All production employees must be trained and tested annually on the following topics:
Food Defence Employee Awareness**, GMPs, Food Safety, Hygienic (health & behaviour)
training. All training must be documented indicating employee name and date of training.

Qualified individuals must provide training.

Management must ensure that employees are trained at sufficient frequency to ensure
that employees remain familiar with applicable principles, at minimum once per year.

2.1.4 Product Information and Consumer Awareness:


Lot Identification
Product Information
Labelling
Consumer Education

3- Production Principles:

3.1 Supply Management:


All production sites must adhere to an established program for the selection and
management of supply including direct materials, food contact materials, primary
packaging and services. The program must include risk assessments, testing frequency,
evaluation and audit frequency, hold and release procedures, and documentation
supporting the program.

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.

3.1.2 Change Management


All new suppliers and toll manufacturers and/or new raw materials, traded goods and
packaging must be documented and approved through the applicable system. The process
must be maintained and monitored by the designated responsible.

3.1.3 Risk Assessment/Testing Frequency/Hold and Release


Risk assessment must be conducted for each raw material, traded goods, packaging based
on process and application. The CoA/CoC must be verified against the specification prior to
use. Based on the risk assessment the testing frequency is determined and the hold and
release criteria defined.

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.

3.1.6 Service Contractors


Services that may impact food safety must be approved, monitored and evaluated every
three years.

A contract/document must be signed accepting compliance to GMP and food safety


requirements.

3.1.7 Conditional Approvals


Suppliers can only be conditionally approved for supply based on a documented risk
assessment with maximum one year validity. All control measures mentioned in the risk
assessment must be followed during the period of conditional approval.

3.2 Storage, Warehousing and Transportation:


All production sites must have established procedures for receiving inspections,
transportation requirements, appropriate storage temperatures, monitoring of
temperature/humidity requirements by area, separation and labeling of non-conforming
materials, stock rotation, designated chemical storage, sanitation, pest control and
maintenance of warehouse equipment.

3.2.1 Receiving/Shipping Procedures


Documentation of receiving and shipping vehicle inspections must be retained; verification
of temperature where required, tampering inspections, etc. Receiving documents
(shipping paperwork) must be verified before unloading.
3.2.2 Storage
All raw materials must be stored according to manufacturer’s recommended storage
conditions or based on an accepted risk assessment in order to maintain specified quality
and food safety. All our products must be stored according to product specifications.

3.2.3 Warehouse Design, Maintenance and Controls


The warehouse or designated storage areas must be designed to allow for scheduled
maintenance, cleaning, pest control and inspections. The storage temperatures, where
appropriate, must be monitored and documented.

3.2.4 outside Storage Areas


Outside storage must be protected against weather and infestation. Scheduled inspections
must be conducted and documented.

3.2.5 Outsourced Storage


All outsourced storage areas and warehouses must follow the standard storage
requirements as described above and must be audited for compliance prior to approval for
storage and per the scheduled audit plan.

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.

3.3 Control of Operations:

1 Control of Food Hazards


Food business operators should control food hazards through the use of HACCP

Identify steps in their operations which are critical to the safety of food;

Implement effective control procedures

Monitor control procedures

Review control procedures periodically

2 Key Aspects of Hygiene Control Systems


Time and temperature control

Specific Process Steps Chilling, thermal processing, irradiation, drying, chemical , vacuum
or MAP

Microbiological Cross Contamination

Physical and Chemical Contamination


3 Packaging
Adequate protection

Packaging materials or gases should be non-toxic

Should not pose threat during storage and use

4 Incoming Raw Material Requirements


Specifications for raw materials should be identified and applied

Raw materials or ingredients should be inspected and sorted before processing

Stocks of raw materials and ingredients should be subjected to effective stock rotation

5 Water
In contact with Food

As an Ingredient

Ice and Steam

Potable Water Should be as specified in WHO Guidelines for Drinking Water Quality or
Water of Higher Standard

6 Documentation and Records


Appropriate records of processing, production and distribution

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:

4.1 Waste Management:


Each production site must have a waste management program that includes the
identification, collection and removal of waste, including drains and drainage.

4.1.1 Waste Containers


All waste containers must be appropriately identified, constructed of material suitable for
the waste material, closed when not in immediate use and stored appropriately in a
designated location, e.g. hazardous waste (applies to production, production offices and
laboratory).

4.1.2 Waste Removal


Waste removal from production areas must be performed daily.

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.

4.2 Chemical Control:

Each production site must have a program for the purchase, storage and use of food grade
and non-food grade chemicals, including boiler chemicals.

4.2.1 Non-Food Grade


Non-food grade chemical storage must be secured and access controlled within the
warehouse and stored per manufacturer’s SDS (Safety Data Sheet).

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.

4.2.3 Food Grade


Chemicals used to food contact equipment, i.e. boiler chemicals and lubricants must be
food grade and stored according to manufacturer’s SDS.

4.3 Cleaning and Sanitation Program:

Each production site must validate and monitor cleaning and sanitation processes (facility,
equipment, tools and utensils).

4.3.1 Zone 1 Validation


Validation: Sanitation of production areas and equipment must be validated based on the
appropriate cleaning program for the specific production area and the equipment
(manufacturer).
The validation must be based on established equivalent, and microbiological analysis and
must be documented.

The validation must be verified at least annually and documented.


This includes CIP (clean-in-place) and SIP (steam-in-place).

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.

4.3.4 Production Tools


Production tools and utensils must be of hygienic design and maintained to prevent
contamination.

4.3.5 Non-Production Areas


Non-production area procedures, e.g. warehouse and zone 4 areas must be established
and documented for cleaning and sanitizing program including frequency, chemicals used
and application methods.

4.3.6 Colour Coding


Cleaning tools must be colour coded according to use and documented in the local
cleaning and sanitation program.

4.4 Environmental Monitoring Program:


The Environmental Monitoring Program must be established and documented as part of
the Food Safety Program. Sampling locations based on zoning classification, frequency and
corrective actions must be defined and documented.

The program must include the frequency for testing and monitoring all zones.

4.5 Pest Control:

4.5.1 Pest Control Service


Each facility must use an authorized external pest control service only.

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.

4.5.2 Reporting and Corrective Actions


The Pest Control company must provide reports after each inspection identifying areas for
improvement to control access to designated areas including potential access points,
external openings, etc.

:‫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

5-Food Safety and Food Security:

5.1 Food Safety Program:


5.1.1 Food Safety Program
Food safety programs must be established to control, monitor and assess food safety risks
per the local controls and corporate requirements.

This includes microbiological, chemical and physical contaminations.

5.1.2 Food Safety Team


The Food Safety team must assure the implementation, verification, monitoring and
auditing of food safety programs.

5.1.3 Change Management


Where applicable, if a food safety process change is required, the food safety responsible
must conduct a risk assessment and approve the change management cycle.
5.1.4 Corrective Action
All food safety related corrective actions (CA) must be documented and verified by the Food
Safety or HACCP team.

5.1.5 Allergen Control


All allergens must be segregated and labeled according to corporate instructions and the
local allergen storage procedure.

Allergen processing change-over procedures must be validated and documented.

5.2 Control of Non-Conforming Materials:


Any material, including packaging, which does not conform to the Food Safety Program,
quality related non-conformities and rework must be identified and controlled.

5.2.1 CCP Non-Conformity (NC)


All NCs related to a CCP must be reviewed by the Food Safety team for potential correction
or action plan. Corrective action and/or action plan must be approved by the Food Safety
Manager/QA Manager.

All non-conforming products related to either a CCP, a regulatory non-conformity or a


potential or actual food safety risk must be blocked and separately labelled and stored in a
quarantined area.

Weekly stock counts are required for all these types of blocked products and must be
documented.

5.2.2 Quality Non-Conformity (NC)


Quality related non-conforming product must be blocked, restricted or labeled per local
procedure.

5.2.3 Rework & Returned Products


Product designated for rework must be labelled, blocked and quarantined.

Use of rework must be approved by the quality responsible.

Complete traceability of reworked product must be maintained. Returned products must be


labelled, blocked and quarantined until evaluated and actions are decided by the quality
responsible.

5.3 Food Security/Defence:


Each production site must have an established food security, traceability, withdrawal, recall,
crisis management, vulnerability assessment and facility access controls.

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.

5.3.2 Product Withdrawal/Retrieval


Product withdrawal/retrieval must be managed and communicated by the appointed Crisis
Management team.

5.3.3 Crisis Management


All facilities must establish and train a Crisis Management team.

A crisis management notification/communication exercise must be conducted annually.

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.

‫ﻋﻣل ﺗﺗﺑﻊ ﻟﻠﻣﻧﺗﺞ ﺳواء ﻣطﺎﺑق او ﻏﯾر ﻣطﺎﺑق‬


‫ﻏﯾر ﻣطﺎﺑق ﻟﻠﻣﻧﺗﺞ ﺑﻌد ﺧروﺟﮫ ﻓﯾﻣﻛن ﻟﻌﻣﻠﯾﮫ اﻟﺗﺗﺑﻊ ﻋن طرﯾق اﻟرﺳﺎﻟﮫ اﻟﻣوﺿوﻋﮫ ﻋﻠﻲ اﻟﻣﻧﺗﺞ ﺗﻔﯾد ﻓﻲ ﻋﻣﻠﯾﮫ ﺳﺣب‬
‫اﻟﻣﻧﺗﺞ ﻣن اﻟﺳوق اﻟذي ﻗد ﯾﺣدث ﺿرر وﺗﺟﻣﯾﻌﮫ ووﺿﻌﮫ ﺗﺣت اﻟﻧظر واﻟﻔﺣص ﺣﺗﻲ ﻻﺗﺣدث اي اﺿرار‬
‫ﺣﯾث ان ﻋﻣﻠﯾﮫ اﻟﺗﺗﺑﻊ ﺗﺑدء ﻣن ﻋﻣﻠﯾﮫ اﻟﺗﺻﻧﯾﻊ ﺣﺗﻲ ﺧروج اﻟﻣﻧﺗﺞ اﻟﻧﮭﺎﺋﻲ اﻣﺎ ﻋﻣﻠﯾﮫ ﺳﺣب ااﻟﻣﻧﺗﺞ ﻣن اﻟﺳوق ﻋﻛﺳﮫ‬
‫ﺣﯾث ﺗﺑدء ﻣن اﻟﻣﻧﺗﺞ اﻟﻧﮭﺎﺋﻲ ﺣﺗﻲ ﻧﺻل اﻟﻲ ﺑداﯾﮫ اﻟﺗﺻﻧﯾﻊ وذﻟك ﯾﺳﺎﻋد ﻓﻲ ﻛﺷف اﻟﺧطﺎء اﻟذي ﺣدث ﻓﻲ اﻟﻣﻧﺗﺞ واﻟﺣﻔﺎظ‬
‫ﻋﻠﻲ ﺳﻼﻣﮫ وﺻﺣﮫ اﻟﻐذاء ﻋﻧد اﺳﺗﮭﻼﻛﮫ‬.

Recall (in separated file)


6- Self-Assessment:

6.1 Auditing:
Each production site must have an established internal auditing program against the
appropriate standard, scheduled frequency, auditor qualifications and corrective actions.

6.1.1 Plant and Support Department Audits


Each production site must plan and execute an internal audit program according to
certification scope and customer requirements.

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.

6.1.2 Auditor Qualifications


Each lead auditor must have prior experience and external lead auditor training to qualify as
a lead auditor.

Each internal auditor must have prior experience and or internal auditor training.

It is recommended that internal auditor training is conducted by an external approved


trainer.

6.1.3 Corrective Actions


All non-conformities must be entered into the corrective action (CA) system, root cause
determined and appropriate CA applied within 30 days, with a follow-up and verification
within 90 days.

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

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