Professional Documents
Culture Documents
GMP Ssop
GMP Ssop
HACCP
cGMP SSOP
INGREDIENTS
FACILITIES PREMISES EQUIPMENT AND
RAW MATERIALS
CLEANLINESS
CHEMICAL PERSONAL
AND
CONTROL HYGIENE
SANITATION
WAREHOUSING TRACEABILITY
SUPPLIER
AND AND PEST CONTROL
CONTROL
DISTRIBUTION RECALL
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GOOD MANUFACTURING PRACTICES
sets of principles on
controls, conditions for
quality and hygienic
handling/processing/
service of foods
SANITATION STANDARD OPERATING
PROCEDURES
establishment-specific
sanitation and hygienic
procedures and practices
interpretation and
implementation of GMP by
establishment
HACCP
cGMP SSOP
FACILITIES
Facilities
building
sanitary facilities
lighting
floors, walls, ceilings, doors
ventilation
water supply
waste disposal system
Facilities
Things to consider:
- design Includes programs for the
- materials following:
Building
Must be designed & constructed to ensure:
- hygienic food handling
- effective cleaning & sanitation
- prevention of entry of pests
- safety of personnel
Facilities
Building
• Location, construction,
maintenance according to
sanitary design principles
• cleaned on a regular basis With the following areas:
• Lay-out follows a straight- - rest & dining areas
line process flow
- locker rooms
- landscape garden/trees
- comfort rooms
- medical clinic
Facilities
Building
Areas of a Plant:
• Receiving area
• Ingredient storage area
• Processing area
• Finished product
warehousing area
• Toilet area
Plant Lay-out
Facilities
Main entrance
A simple
factory layout Laboratory Administration
with all
departments
housed within a
single
compound
Production Area EA
Raw
Raw Material Storage FPS
materials
EA = Employee amenities
Final
FPS = Finished Products Storage products
GOOD MANUFACTURING PRACTICES
Raw
materials
Alternative
arrangements Raw Material Storage
of
departments Main
entrance A
under a single
compound Production Area
A = Administration
L = Laboratory L
Finished Product Storage
EA = Employee EA
amenities
Final
products
Facilities
Sanitary Facilities
• Supplied with running water
• Handwashing sink near processing
area & comfort rooms
• Sinks provided with soap, nail
brush & clean towels
• Facilities for washing &
disinfecting equipment
Facilities
Lighting
• Source: fluorescent light with no glare &
shadow
• Provided with a cover
• Adequate
• Required in food preparation area,
warewashing area, handwashing
stations, restrooms
Facilities
Floors
• Concrete, kept clean regularly, free of
debris, & properly drained
• Durable & water resistant
• No cracks, depression, or low areas
• Drains & gutters carefully planned &
located
Facilities
Walls & Ceilings
• Impervious to moisture, easily
cleanable, smooth & light colored
• Walls can be tiles, cement blocks,
bricks, concretes & metals
• Roof is simple, watertight, sufficiently
high, & adequately vented
• Coving between walls, walls & floors &
walls & ceilings should be sealed
Facilities
Doors
• Wide
• Open outward
• Made of corrosion-resistant or suitable
metal with adequate impact strength
• Self-closing
• With air screen or plastic curtain
Facilities
Ventilation
• Remove obnoxious odors, heat, &
moisture from the plant
• Introduce fresh air, free of any foreign
odors & product contaminants
• Provide a comfortable environment for
the employees
• Exhaust fan made of rustproof-coated
steel
Facilities
Water Supply
• Sufficient for operations from adequate
source
• Safe & sanitary quality
• Suitable temperature
• Under pressure as needed
• Supplied by a reputable source
Facilities
Waste Disposal System
• Must meet regulatory requirements
• Must not cause pollution problems or
create breeding places for pests
• Sewage system is connected to the
public sewerage system
HACCP
cGMP SSOP
FACILITIES PREMISES
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Premises
• area where the plant is
located and its
Includes programs for
surroundings the following:
cleaning and
sanitation
maintenance and
repair
pest control
Premises
• maintained such that food is
kept from adulteration and
contamination
• should also consider security
and safety • location & size must support
& facilitate maintenance &
sanitary operations
Premises
Other considerations…
- no domestic animals
- free from garbage/ waste - free from objectionable odors,
- free from pollution and dirt smokes, dust & other
contaminants
- no flooding
- no weeds or grass
- concrete roads & parking
space
HACCP
cGMP SSOP
PRODUCTION
FACILITIES PREMISES
EQUIPMENT
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Production Equipment
Documents provided
by the supplier to a
client receiving a
product based on
compliance to a set
of specifications
agreed upon
FCC Products,Inc.
106 Naylon Avenue
Livingston, NJ 07039
CERTIFICATE OF ANALYSIS
To:
Lot No:
Quantity:
Product: Apple Cider Vinegar
DESCRIPTION: A composition made from maltro-dextrin, distilled vinegar, and natural flavor. The vinegar
is truly entrapped in a non-hygroscopic matrix.
LABEL DECLARATION: Malto-dextrin, Distilled Vinegar and Natural Cider Flavor.
SPECIFICATIONS: All components of this flavor are approved for use in foods by the
Food & Drug Administration.
Moisture…………………….. Less Than 5%
Particle Size…………………..100% through 16 mesh
Acidity……………………….. Less Than 5% as Acetic Acid
Manufacturing Date:
Expiration Date: 18 Months from Manufacturing Date
This product has not been ETO treated.
To the best of our knowledge, this product is not GMO.
Letter of Guarantee
PERSONAL HYGIENE
Personal Hygiene
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Personal Hygiene
Management’s Responsibility
• To evaluate employee training program,
ask these questions:
– Did the training produced results on the job?
– If intended results ere not produced, why not?
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Personal Hygiene
Management’s Responsibility
• Hiring the right employees
• Using task analysis to determine the food safety
and sanitation requirements for each job
• Establishing employee rules
for personal hygiene
• Supervising and training employees
in good personal hygiene and
food safety practices
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…Personal Hygiene
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HACCP
cGMP SSOP
INGREDIENTS
FACILITIES PREMISES EQUIPMENT AND
RAW MATERIALS
CHEMICAL PERSONAL
CONTROL HYGIENE
Chemical Control
• Follow appropriate
segregation, labeling, use
& storage procedures of
food & non-food
chemicals
HACCP
cGMP SSOP
INGREDIENTS
FACILITIES PREMISES EQUIPMENT AND
RAW MATERIALS
CLEANLINESS
CHEMICAL PERSONAL
AND
CONTROL HYGIENE
SANITATION
Cleanliness and Sanitation
Effective management of sanitation
programs includes education,
participation & proper delegation of
responsibilities among employees
Written detailed plans, procedures,
schedules & checklists regarding
cleaning & sanitizing of food & non-food
processing equipment & facilities
Evaluation of existing cleaning
procedures
Detailed program of control for storage
& use of cleaning & sanitizing chemicals
Cleanliness and Sanitation
FOOD PLANT SANITATION IS EVERYONE’S
CONCERN!
TOP
MGT.
MIDDLE
MANAGEMENT
Sanitation Plant
Manager Manager
QA HRD
Manager Manager
Safety
Production
Manager
Manager
HACCP
cGMP SSOP
INGREDIENTS
FACILITIES PREMISES EQUIPMENT AND
RAW MATERIALS
CLEANLINESS
CHEMICAL PERSONAL
AND
CONTROL HYGIENE
SANITATION
WAREHOUSING
AND
DISTRIBUTION
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Warehousing and Distribution
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…Warehousing and Distribution
Lot Identification
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…Warehousing and Distribution
Lot Identification
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…Warehousing and Distribution
Storage Principles
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…Warehousing and Distribution
Storage Principles
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…Warehousing and Distribution
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…Warehousing and Distribution
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…Warehousing and Distribution
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HACCP
cGMP SSOP
INGREDIENTS
FACILITIES PREMISES EQUIPMENT AND
RAW MATERIALS
CLEANLINESS
CHEMICAL PERSONAL
AND
CONTROL HYGIENE
SANITATION
WAREHOUSING TRACEABILITY
AND AND
DISTRIBUTION RECALL
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Traceability and Recall
System which implements
proper coding or labeling
of raw materials and
finished products in the
anticipation of
circumstances which will
require complete traces of
product retrievals
Traceability and Recall
Benefits:
• Lower cost of distribution
• Reduced recall expenses
• Expanded sales of high-value
products
• Larger net revenues
Farmer’s markets/
Consumers
Roadside stands
Intermediaries:
Wholesalers/brokers/
Exports Imports
repackers/exporters/
importers
Shippers
Growers Processors
RECALL
- It is a firm’s voluntary removal of product
from trade or consumer channels (e.g.
importers or manufacturers) to protect the
public from consuming adulterated or
misbranded products
Traceability and Recall
RECALL
any corrective action by a company
needed to protect consumers from
potentially adverse effects of a
contaminated, adulterated, or
misbranded product
Traceability and Recall
RECALL
- It may be an alternative detention or
seizure of adulterated or misbranded
product
- Does not include a market withdrawal or
stock recovery
a Successful Recall Process
• Planning ahead
• Acting quickly
• Effective communication during a recall
• Recall assessment
Traceability and Recall
Market withdrawal
• Used when a minor violation is not
subject to legal action
Precautionary Hold
• Product suspected of adulteration/
contamination restricted for use, held &
labeled pending confirmation of test
results, risk assessment, etc.
Complaint Source
Government Agency Vendor/
Vendor Product Recall
Obtain Manufacturer
Customer Withdrawal Y Batch Info Distributor
Consumer Distribution
Lot Number Broker
Employee Reversal
Container Label Customer
Routine Lab Results needed
Caterer
Other
N
Formally notify customers thru mail or phone call:
1. Product number/ volume produced
2. Batch number, lot number, production date,
spec number
3. Container label
Handle as appropriate 4. Reasons for recall/ withdrawal
5. Manufacturing location
6. Location of distribution
7. Number of cases sent to locations
8. What is its brand
Product Recall/Hold/Withdrawal 9. What to do with products
Communication Flow Chart 10. Notify authorities as appropriate
Traceability and Recall
Recall Classifications
• Class 1 – health hazard situation where there is a reasonable
probability that use of the product will cause serious adverse
health consequences or death
ex. E. coli O157:H7 in ground beef
• Class 2 – health hazard situation where there is a remote
probability that use of the product will cause adverse health
consequences
ex. Histamine (undeclared)
• Class 3 – health hazard situation where the use of the product
will not cause adverse health consequences
ex. GRAS (undeclared), excess water
Traceability and Recall
Depth of Recall
1. Consumer level (consumer)
2. Retail level (retail stores)
3. User level (hotel, restaurants)
4. Wholesale level (between manufacturer & retailer)
Health Hazard Evaluation
• Nature of the violation or defect
• Occurrence of illnesses or injuries
• Likelihood that illnesses may result
• Type of illnesses or injuries that may result
• Procedure to determine the need for a recall
Traceability and Recall
Recall Notice Report (RNR)
• Provide consumers & public health community with
information related to product in question
• Posted in Regulation Agency Recall website
• Electronically distributed to public health & inspection
program officials throughout the country with the date & recall
case numbers
Parts of RNR
• Specific product recalled with identifying codes
• Name of recalling firm, contact person & phone nos.
• Quantity of product recalled
• Reason for recall, how & when it was discovered
Traceability and Recall
Recall Notice Report (RNR)
HACCP
cGMP SSOP
INGREDIENTS
FACILITIES PREMISES EQUIPMENT AND
RAW MATERIALS
CLEANLINESS
CHEMICAL PERSONAL
AND
CONTROL HYGIENE
SANITATION
WAREHOUSING TRACEABILITY
SUPPLIER
AND AND
CONTROL
DISTRIBUTION RECALL
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Supplier Control
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…Supplier Control
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…Supplier Control
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…Supplier Control
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Pest Control
Documentation
Training
Verification Activities
MANAGING PREREQUISITE PROGRAMS
Documentation
Written guidelines &
procedures
Records of previously
encountered problems &
solutions that were
implemented
MANAGING PREREQUISITE PROGRAMS
Training
Periodic
Well-designed
Will cater to all level of employees
MANAGING PREREQUISITE PROGRAMS
Verification Activities
Routines performed by supervisors
that guarantee the implementation of
corrective actions & that programs are
functioning as intended
PREREQUISITE PROGRAM ASSESSMENT