GMP-SSOP

cGMP
FACILITIES CHEMICAL CONTROL WAREHOUSING AND DISTRIBUTION

HACCP

SSOP
INGREDIENTS AND RAW MATERIALS CLEANLINESS AND SANITATION PEST CONTROL

PREMISES

EQUIPMENT

PERSONAL HYGIENE TRACEABILITY AND RECALL SUPPLIER CONTROL

•co

GOOD MANUFACTURING PRACTICES

 sets of principles on controls, conditions for quality and hygienic handling/processi ng/ service of foods

SANITATION STANDARD OPERATING PROCEDURES
 establishmentspecific sanitation and hygienic procedures and practices  interpretation and implementation of GMP by establishment

cGMP
FACILITIES

HACCP

SSOP

Facilities
 building  sanitary facilities  lighting  floors, walls, ceilings, doors  ventilation  water supply  waste disposal system

Facilities
Things to consider: - design - materials - construction - layout Includes programs for the following:  cleaning and sanitation  maintenance and repair  pest control

Facilities
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 • Lay-out follows a straight-line process flow

With the following areas: - rest & dining areas - locker rooms - landscape garden/trees - comfort rooms

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 with all departments housed within a single compound

Laboratory

Administration

Production Area

EA

Raw materials

Raw Material Storage

FPS

EA = Employee amenities FPS = Finished Products Storage

Final products

GOOD MANUFACTURING PRACTICES
Raw materials Alternative arrangements of departments under a single compound

Raw Material Storage Main entrance A Production Area

A = Administration L = Laboratory EA = Employee amenities L EA Finished Product Storage

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 &

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 rustproofcoated 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

cGMP
FACILITIES

HACCP

SSOP

PREMISES

•co

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, smokes, dust & other contaminants - free from pollution and dirt - no weeds or grass - no flooding - concrete roads & parking space

cGMP
FACILITIES

HACCP

SSOP

PREMISES

PRODUCTION EQUIPMENT

•co

Production Equipment
• The primary objective is to prevent adulteration and contamination of raw materials and food products with lubricants, fuel, fragments or any other foreign matter.

Production  constructed & installed in compliance with Equipment sanitary principles
 Made of stainless steel/plastic and foodgrade  Made of impervious corrosion-resistant, easily cleanable, resistant to chipping, & durable material  Smooth seams on food-contact surfaces

Production  installed & kept in manner that supports Equipment
 preventive maintenance;  calibration; and  cleaning schedules  replacement of malfunctioning parts;

EXAMPLE OF BAD DESIGN

Production TANK Equipment

Products cannot be drained

EXAMPLES OF DESIGN

Production GOOD TANK Equipment

CORRECT VATS & TANKS

Production ARRANGEMENTS OF Equipment

The tank on the left is difficult to clean around, hence floor debris is apt to accumulate beneath it.

cGMP
FACILITIES

HACCP

SSOP
INGREDIENTS AND RAW MATERIALS

PREMISES

PRODUCTION EQUIPMENT

Ingredients & Raw Materials  Should be received, stored, handled &
transported under specific sanitary & environmental conditions  Have Certificate of Analysis (COA) or Letter of Guarantee (LOG) May be based on international standards & publications based on scientific research Should include sampling procedures, analytical methodology & limits for acceptance

Certificate of Analysis
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
Document stating that the material has been processed in a way that the buyer’s specifications are met

Ingredients & Raw Materials  Inspected as soon as it is issued from the
stockroom  Do sensory & chemical analysis  Canned raw material should be analyzed according to quantity, expiry date, and presence of dents, bulges, punctures, and leakage  Fresh raw material should be analyzed based on weight, presence of soil particles, bruises, discoloration  Results of inspection should be recorded in a Raw Material Inspection Form  Return non-conforming raw materials to supplier

Ingredients & Raw Materials  Store properly
 Follow FIFO  When in doubt, throw it out!  Never put raw food over prepared food.

cGMP
FACILITIES

HACCP

SSOP
INGREDIENTS AND MATERIALS

PREMISES

EQUIPMENT

PERSONAL HYGIENE

Personal Hygiene
… Are sanitary health habits that include keeping the body, hair, & teeth clean; wearing clean clothes; & washing hands properly.

Personal Hygiene
 proof of good health (medical and dental certificates)  health questionnaire & reporting agreement  regular training of personnel  procedures on handling personnel with illness  first aid kit accessible

Personal Hygiene
 daily bath and other hygienic practices  complete and clean uniform  use of gloves, hairnet and face mask for food handlers  frequent hand washing

Personal Hygiene
Pathogenic microorganisms transmitted through food handling  Hepatitis A virus  Norwalk & Norwalk-like viruses  Salmonella spp.  Shigella spp.  Staphylococcus aureus  Streptococcus pyrogenes  Escherichia coli O157:H7

Personal Hygiene
General Guidelines
A. Protective Clothing  Suitable, company issued protective clothing shall be worn in food production or storage areas B. Laundry  Protective clothing should be laundered regularly & effectively  Adequate changes of protective should be available  Storage of clean protective clothing should be available  Clean & soiled protective clothing should have separate storage bins

Personal Hygiene
General Guidelines
C. Staff Change Facilities  Personal lockers should be available  Clean or soiled protective clothing should not be stored in lockers  Periodic checking for compliance of locker should be done D. Protective Hair Covering  Disposable (if possible)  Worn by all in production or storage areas  Beards should also be covered

Personal Hygiene
General Guidelines
E. Personal Hygiene  Wash hands prior to entering food production or storage areas and in between food handling  Fingernails should be kept short, clean & unvarnished  Gloves should be suitable, disposable, changed frequently & their disposal controlled to avoid product contamination  Cuts & grazes should be covered with waterproof plasters F. Jewelry  Observe company rules on jewelry while in food production areas

Personal Hygiene
General Guidelines
G. Eating, Smoking & Drinking  Strictly restricted to designated areas  Must be followed by proper hand-washing G. Health Screening  All staff who will be entering food production, storage & packing areas should complete a Company Health Questionnaire

PERSONNEL INSPECTION CHECKLIST
YES Are workers with communicable illnesses prohibited from working with food products? Are uniforms frocks clean & neat? Do workers was their hands after using the restroom? Do workers wash their hands before returning to work & after eating breaks? Are workers informed of proper handwashing procedures? Do workers remove their jewelry or personal effects while working? Do workers pay attention to personal hygiene? Do policies prohibit eating, drinking or smoking in the processing area? Are routine training programs held? NO

Personal Hygiene
Management’s Responsibility

• • • •

Develop job assignments Provide adequate facilities Lead by example Provide ongoing supervision and training

•co

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?

•co

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
•co

…Personal Hygiene

“…in any type of processing operation, the primary consideration in food safety is PEOPLE. The effectiveness of any food safety program heavily depends on the attitude, willingness and effort of people to follow personal hygiene practices…”

•co

cGMP
FACILITIES CHEMICAL CONTROL

HACCP

SSOP
INGREDIENTS AND RAW MATERIALS

PREMISES

EQUIPMENT

PERSONAL HYGIENE

Chemical Control
• Follow appropriate segregation, labeling, use & storage procedures of food & non-food chemicals

cGMP
FACILITIES CHEMICAL CONTROL

HACCP

SSOP
INGREDIENTS AND RAW MATERIALS CLEANLINESS AND SANITATION

PREMISES

EQUIPMENT

PERSONAL HYGIENE

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

SHOP FLOOR WORKERS

Cleanliness and Sanitation SANITATION COMMITTEE
Sanitation Manager QA Manager Production Manager Plant Manager HRD Manager Safety Manager

cGMP
FACILITIES CHEMICAL CONTROL WAREHOUSING AND DISTRIBUTION

HACCP

SSOP
INGREDIENTS AND RAW MATERIALS CLEANLINESS AND SANITATION

PREMISES

EQUIPMENT

PERSONAL HYGIENE

•co

Warehousing and Distribution
• Act of depositing, storing, organizing and stocking goods • Act of delivering to retail outlets /markets as ordered/needed.

•co

…Warehousing and Distribution Lot Identification

• Lot – a definitive quantity of a commodity produced under essentially the same conditions • Each container should be embossed or permanently marked in code or in clear to identify producing factory and lot

•co

…Warehousing and Distribution Lot Identification

• Permanent, legible and dated records and pertinent processing details should be kept for a period exceeding the shelf-life of the product but not exceeding two years • Records regarding initial distribution of the lot should be kept • Necessary for warehousing
•co

…Warehousing and Distribution Storage Principles

• First-in-First-Out (FIFO) System should be implemented. • Goods should be used in the order in which they are delivered • Create a system, such as dating goods on receipt and placing new deliveries behind those already in storage to guarantee that FIFO is followed
•co

…Warehousing and Distribution Storage Principles

• Keep potentially hazardous foods out of the temperature danger zone (40˚F - 140˚F or 4.4˚C - 60˚C). • Store food products and raw materials separately only in designated areas for storage in order to eliminate the risk of contamination

•co

…Warehousing and Distribution

• Keep all goods in clean, undamaged wrappers or packages • Elimination/ minimizing contamination of goods during storage • Periodic inspection of product during storage.

•co

…Warehousing and Distribution

• Keep storage areas clean and dry • this rule applies to dry storage, refrigerators, freezers, and heated cabinets • Keep vehicles for transporting food clean

•co

…Warehousing and Distribution

• Finished products should be stored and transported under conditions that will protect against contamination, deterioration of the product and damage to the container • Periodic inspection of products during storage should be done • Products should be dispatched following a specific sequence
•co

cGMP
FACILITIES CHEMICAL CONTROL WAREHOUSING AND DISTRIBUTION

HACCP

SSOP
INGREDIENTS AND RAW MATERIALS CLEANLINESS AND SANITATION

PREMISES

EQUIPMENT

PERSONAL HYGIENE TRACEABILITY AND RECALL

•co

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
• All raw materials and products should be lot-coded and recall system in place so that rapid and complete traces and recalls can be done

Traceability and Recall
Benefits: • Lower cost of distribution • Reduced recall expenses • Expanded sales of highvalue products • Larger net revenues

Farmer’s markets/ Roadside stands Food service

Consumers Retailers Intermediaries: Wholesalers/brokers/ repackers/exporters/ importers

Exports

Imports

Shippers

Growers

Processors

Tracing fresh produce through the food marketing system

Traceability and Recall
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 Customer Consumer Employee Routine Lab Results Other

Product Recall Withdrawal Distribution Reversal needed

Y

Vendor/ Obtain Manufacturer Batch Info Distributor Lot Number Broker Container Label Customer Caterer

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 4. Reasons Handle as appropriate 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 to do with products 9. What 10. Communication Flow Chart Notify authorities as appropriate

N

Traceability and Recall
Recall Classifications hazard situation where there is a • Class 1 – health
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. 2. 3. 4. Consumer level (consumer) Retail level (retail stores) User level (hotel, restaurants) Wholesale level (between manufacturer & retailer)

Health Hazard • Nature of Evaluationthe 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 • 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

Parts of RNR

Traceability and Recall
Recall Notice Report (RNR)

cGMP
FACILITIES CHEMICAL CONTROL WAREHOUSING AND DISTRIBUTION

HACCP

SSOP
INGREDIENTS AND RAW MATERIALS CLEANLINESS AND SANITATION

PREMISES

EQUIPMENT

PERSONAL HYGIENE TRACEABILITY AND RECALL SUPPLIER CONTROL

•co

Supplier Control
… Are established measures that determine whether suppliers have effective GMP, HACCP or food safety program in place. • Consistent monitoring or control of supplier’s HACCP implementation will reduce or prevent potential hazards that could occur in the raw material or ingredient.
•co

…Supplier Control

Types of Supplier Control used by firms: 1. Receipt of raw materials only from known sources of supply 2. HACCP Plan required for classification as ‘certified suppliers’. 3. Inspection of ingredients and shipping containers for evidence of unsanitary conditions. 4. Shipping containers should include record of prior use and cleaning
•co

…Supplier Control

…Types of Supplier Control used by firms 5. In-house lab analysis and random sampling. 6. Quick tests of indicator parameters used to assess acceptability of raw materials. 7. Screening of new vendors which includes initial sample analysis by outside laboratory and random sampling for 6 months

•co

…Supplier Control

…Types of Supplier Control used by firms 8. Vendor audits performed by third parties. 9. Documentation of problems with supplier’s products

•co

…Supplier Control
Examples of Questions to Ask: • What are the standards of sanitation used? • Does the supply company follow approved practices in handling products? • If it handles refrigerated or frozen products, is it equipped to do the job? • Is there enough warehouse space? • Are delivery trucks adequately refrigerated?

•co

…Supplier Control
• Are employees cooperative and are they trained in sanitary practices? • Is the supplier willing to make deliveries when the personnel are not rushed so that food can be handled quickly and properly?

• Are minimal bacterial requirements for specific products met?
• Is the product quality consistent?
•co

cGMP
FACILITIES CHEMICAL CONTROL WAREHOUSING AND DISTRIBUTION

HACCP

SSOP
INGREDIENTS AND RAW MATERIALS CLEANLINESS AND SANITATION PEST CONTROL

PREMISES

EQUIPMENT

PERSONAL HYGIENE TRACEABILITY AND RECALL SUPPLIER CONTROL

•co

Pest Control
 Effective measures that prevent the entry & proliferation of pests from receiving, processing, packaging & storage areas  Establishments & surrounding areas regularly examined for infestation  Continuous application through effective sanitation & use of chemicals

Pest Control
 Examples of Pest Control Program  Double-screened windows & doors  Self-closing door  Elimination of cracks in floors & walls  Double-screened gutter drains  Placing garbage cans outside the plant & far from the processing area

Pest Control
 Examples of Pest Control Program  Covered food storage  Food storage 6 inches above the floor & from the wall  Cleaning spills immediately  Use of hanging flypapers & glue traps  With the aid of a pest control company

MANAGING PREREQUISITE PROGRAMS

 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
 Check existence & effectiveness during design & implementation of HACCP plan  Document & regularly audit progress  Aspect that may be incorporated into HACCP plan

Sign up to vote on this title
UsefulNot useful