Formation gmp egypte لكل مهندسين الجودة

GMP TRAINING – Egypt 2007- Direction Qualité Groupe - Version A – Page 1

Good ManufacturingGood Manufacturing Practices Practices TRAININGTRAINING

BFDP – Egypt – Oct/nov 2007


• Personal Hygiene

• Sanitary practices

• Ingredient process and product integrity

• Record keeping and coding

• Premises & risk zones

• Maintenance

• HACCP



Personal Hygiene


RECEIVING PRODUCTION PACKAGING SHIPPING

IT ’ S EVERYONE RESPONSABILITY

Hygiene


• No Person affected, a carrier of, or exposed to the following shall work with ingredients or finished products, these include:– Communicable Disease– Boils, open sores– Infected Wounds– Other sources of microbiological contamination

A physician shall make the final decisions in all questionable cases.

Personal hygiene


Hair and beard restraints

• All employees must wear hairnets while in the plant. • Baseball caps, winter caps, bandanas, etc are not

considered as acceptable hair restraints.• A neat mustache may be worn.

• Handlebar mustaches are not acceptable unless a beard net is worn.

• A neat beard is permissible if the employee wear a beard restraint. Beard restraints are required for goatees.

• Long sleeves or plastic sleeves are required to be worn by employees who work directly with exposed product.


MUST

WEAR

BEARDNET

BEARDNET

NOT

NEEDED

Facial hair


Side burns


Hair nets


Nail polish and fake nails are not permitted in the plant

Hands and nails MUST be kept clean at all times.

Nail polish


– Rings, earrings, necklaces, watches and other jewelry shall not be worn in the plant because:

• Jewelry may fall into the product• Jewelry cannot be adequately sanitized against

bacteria transmission• Jewelry may present a safety hazard

Jewelery


The proper uniform includes clean white pants, white shirt

and/or lab coat, hairnet, helmet, beard net if needed

and safety glasses.

Employees may not wear uniforms or work shoes outside

plant property.

Uniforms must be clean at the start of operation and

kept reasonably clean during operation.

Uniforms


Proper attire

•Street clothes are not permitted to be worn inside the plant unless under uniform.

•Company issued jackets are available.


Safety shoes add safety against slips and falls.

Shoes do not have laces so they don’t harbor bacteria

Shoes do not leave the plant so there is no cross-contamination

Safety shoes


Food & drink


•Food and drink is not permitted in the plant, except in authorized lunch and break areas. •Food and drink may not be carried through the plant. •Lunches MUST be stored in the cafeteria refrigerator. •Food and drink CANNOT be stored in work areas or lockers.•Food and drink may not be carried through the plant even if it is unopened.

Food & drink


• Smoking is not permitted anywhere on the premises

• Gum & smokeless tobacco use is not permitted in the plant, and should not be carried in employees’ work clothes at any times.

Smoking


• Employees are not allowed to:– Chew gum– Eat hard candies – Use cough drops

THESE ITEMS MAY END UP THESE ITEMS MAY END UP IN THE PRODUCTIN THE PRODUCT

• Employees contaminate their hands each time they put things in or take things out of their mouth

Candy & gum chewing


Sanitary Practices


Hand washing & sanitizing

• Wash and sanitize hands thoroughly in hand washing facility – Before starting work– After each absence from work area– After visiting restroom– Any time hands have become soiled or contaminated

• Sanitize when entering production/packaging from another department or hallway


Wet Hands thoroughlyWith warm water

Apply soap generouslyScrub under nails. Rub

Hands vigorously for at least20 seconds

Rinse hands thoroughly with warm water

Dry hands using blow dryer or

single use towel

Hand washing


Hand washing and sanitizing

• After washing/sanitizing AVOID– Touching face, wiping forehead, placing fingers on or in

mouth, nose, ears– Scratching uncovered areas of the head or body– Handling product samples in an unsanitary manner

• Avoid uncontrolled, uncovered coughing or sneezing– Notify your supervisor and leave area if excessive

coughing/sneezing occurs– Wash and sanitize hands before returning to work


Foot Baths and Foot Foamers• The bacteria that are present

on shoes are a major source of contamination

• All employees and visitors must use the foot baths to minimize the spread of bacteria due to foot traffic

• Foot baths must be cleaned, refilled and tested each shift

If footbaths are dirty they can be a source of

contamination


Wooden Handles, Ladders, Etc.• Wooden handles are not acceptable on equipment in

processing and packaging areas • Undesirable bacteria can live and grow in the scratches,

crevices and cracks in the wood• All handles should be made of plastic or fiberglass


Equipment Sanitizing

• After cleaning use approved sanitizer solutions to sanitize utensils such as, but not excluding:– Spatulas– Knives– Cheese triars– Thermometers


Clean - Up

• Keep equipment clean and well maintained at all times

• Place all dismantled equipment – parts, pipes, cleaning aids, etc. on specifically designated carts or racks.– Store clean mats off of floor to dry

DO NOT dispose of garbage until the end of the shift- Do not drag full garbage bags across floor


Equipment Storage

• Do Not– Store parts on the floor– Drag clean equipment across floor– Splash water from floor or unclean

equipment onto clean equipment– Take toolboxes into restrooms– Store production cleaning equipment

with floor cleaning equipment


RED RED –– RAWRAW

YELLOW YELLOW –– NONNON--CONTACT SURFACESCONTACT SURFACES

BLUE BLUE –– PASTEURIZED PRODUCT CONTACT PASTEURIZED PRODUCT CONTACT SURFACESSURFACES

BLACK BLACK –– DRAINSDRAINS

To prevent cross contamination use the proper brushes and buckets:

Colored Brushes/Buckets


Cleaning/Maintenance

• Regularly inspect, clean and replace product contact gaskets

• Discard cleaning brushes with loose bristles, as the bristles could end up in finished product.


Cleaning/Maintenance

• Follow cleaning procedures outlined by dept. guidelines– Prior to usage equipment should be

reassembled, sanitized, rinsed and drained


Safe Chemical Handling

• Follow instructions and use extreme care when using certain chemicals– Remember –

NEVER MIX CHLORINE & ACID

Buckets and containers should be labeled so chemicals are not mixed


Pests & Prevention• Keep doors closed at all times to

maintain designed air balance and to keep dust, rodents, birds, and insects from entering the plant

• Do not bring live plants, flowers, or animals into production areas or offices and corridors that open directly into production areas


Record all pest sightings in log book in QC office

Pest Control – Pest Sightings


Ingredient, Process andProduct Integrity


Finished products and raw ingredients must be handled and stored with care to

prevent exposure to foreign material

Ingredient, Process and Product Integrity


KEEP RAW MATERIALS REFRIGERATED

Raw Materials• Maintain bagged raw materials in a neat and

orderly manner• Clean surface of raw material bags before bringing

to processing/packaging area• Do not place or store raw materials or finished

goods on floor• Close and identify (if necessary) contents of

partially used raw material bags• Damp wipe and sanitize tops of ingredient

containers before opening


Handling of Raw Materials and Samples

• Unwrapped product, packaging materials and equipment that contacts exposed product shall not be handled with– Injured or bandaged hands unless protected by

gloves• Gloves must be intact, clean and sanitary

– Cuts and open sores on fingers and hands unless covered by colored band-aid and rubber or plastic finger cot (detectable through metal detector when possible)


• Unwrapped product that comes in contact with the floor must be considered waste.

• If packaged product touches the floor, and the seal is broken or the cup cracks, then this product is considered waste.

• It is never acceptable to return product to the line once it has come in contact with the floor.

Product on Floor


• Bacteria that are present on floors and in drains can be deadly

• Storing product in a corrugated box directly on the floor is not acceptable

Product on Floor


• All containers must be properly labeled.

• Cleaning solutions, chemicals, and even distilled water must be stored in containers that are clearly labeled.

Proper Labeling of Containers


• Packaging materials CANNOT be used for storage of supplies or ingredients

• All ingredients must be kept in closed containers until immediately before use

• Boxes, bags and film should never be stored directly on the floor

• Packaging materials must be covered when not in use

Supplies and Ingredients


Small glass bulb inside

Glass

• Use of glass is PROHIBITED in the plant

• pH electrodes have a glass bulb but are protected by plastic body


Thermometers

• Thermometers are issued with a number on the back for tracking purposes

• Employees have a thermometer assigned to them if their job requires it

• It is the responsibility of the employee to be accountable for their thermometer at all times


Record Keeping andCoding


Code Dating

• All code date printing must be legible and easily visible

• Report deviations in coding immediately to supervisor


Mozzarella


Weight Checks

The average weight of each lot must equal or exceed the weight declared on the product label.

Individual packages cannot be below the MAV (Maximum Allowable Variation) specified for that product.

Each department must monitor and document weight checks. This includes: calibration records, operating procedures, and corrective action for deviations.


Chart Recorders

• All temperature control charts shall be identified, maintained, monitored, and signed.

• All deviations on the chart must be highlighted and explained


Premises


The building and surroundings shall be kept clean and orderly toprevent harborage of pests and contaminants.

Premises


• Where possible, stack raw materials, supplies and finished products 18 inches from interior walls to allow: Access for inspection Access for rodent control operations Cleaning Buffer zone to keep load off walls Fire safety

Perimeter


Contamination Prevention

• Clean up broken packages or spilled product immediately

• Do not use dirty or broken pallets

• Store pallets in areas free from bird, insect and rodent contamination


Exterior

• Do not stack or store materials within 3 feet of the building exterior

• Littering is prohibited. Keep docks, smoking, and parking areas litter free

• Put all refuse in covered trash containers

• Dumpster lids must be closed after use


• Doors that separate processing and packaging rooms must be kept closed to prevent contamination

• All door/window screens must be in place to prevent pests from entering the plant

Air Quality


Risk zones

A risk zone

Is a defined and limited space

In which products are particularly vulnerable

To biocontamination


Different risk ZONES

EXMAPLES OF DIFFERENCES : ACESS CONDITIONS CLEANING & DISINFECTION PERSONAL HYGIENE & BEHAVIOUR AIR QUALITY

GREY ZONE : Unlimited & free acess

WHITE ZONE : PROTECTED ACESS

RED ZONE : LIMITED ACESS


Flux control

Personnel ofproductionmaintenancelaboratorycleaningservices

Finished productsMaterialsWaste waterAirWastes

Personnel ofproductionmaintenancelaboratorycleaningservices

Raw materialspackagingMaterialsWaterAirPests


MAINTENANCE &FOOD SAFETY


Types of interventions

• Planned or preventive

• Curative


Types of interventions

• Intervention out of production

• Intervention during production


Contamination hazards related or due to maintenance activities

• Foreign bodies hazards

screws & nuts, tools, chips, metal particles, hair,...

• Chemical hazards

oils, grease, acids

• Microbiological hazardshands, hair, tools

GRAISSE


Uniforms


Lubricants

Attention :

Use specific and dedicated tools, for food grade lubricants and non food grade to prevent cross contamination


•Precise diagnosis of breakdown

•Identification of pieces to change

•Inventory of necessary material

Evitate going back and forth

Breakdown visit


•Gather tools and spare parts needed•Eliminate paper and cardboard packaging•Unpack spare parts•Decontaminate when intervening in high risk areas

Material preparation


•Dedictaed tool box to each area•Cleaned regularly•No wood or cardboard•Clean tools and in good state

Tool box


Tool cart


Cleaning & disinfection of tools and materials


Preparation before intervention

•Trace intervention zone

•Protect machines around zone

•Evacuate packaging materials and protect them

•Protect surfaces that are in contact with food


•Plan for using single use protective covers

•Don’t introduce cardboard to protect the floor

•Complete cleaning of area after intervention

Breakdown intervention


•Sort out and clean up area•Eliminate wastes•Clean equipment•Test equipment•Precise eventual recommandations to line conductor•Write report of intervention•Keep record of intervention

End of intervention


• working order

• equipment record of intervention

• communication notepads

• GMAO

• ...

Communication


HACCP


HAZARD

ANALYSIS

&

CRITICAL

CONTROL

POINT

HACCP


Food Safety Hazard: Any biological, chemical, or physical property that may cause food to be unsafe for human consumption

Critical Control Point: A point, step, or procedure in a food process at which control can be applied and, as a result, a food safety hazard can be prevented, eliminated, or reduced to acceptable levels

HACCP


CCP example 1 ANTIBIOTIC SCREENING

HACCP


CCP example 2 MILK PASTEURIZATION

Time:

15 seconds

Temperature: 72°C

HACCP


CCP example 3 METAL DETECTION

HACCP


CCP example 3 METAL DETECTION

HACCP


Science

Formation gmp egypte لكل مهندسين الجودة