Welcome to Current Good Manufacturing Practices
This course describes key components of Good Manufacturing Practices (GMPs) as published in Title 21 of the FDA's Code of Federal Regulations, Part 117 — the requirements that must be observed and practiced during fresh produce processing.
What You Will Learn
This self-directed online course is designed for food safety professionals, supervisors, managers, and workers involved in fresh produce processing. By the end of this course, you will be able to:
- Navigate the key elements of GMP requirements under 21 CFR Part 117
- Identify critical food safety hazards associated with fresh produce processing environments
- Describe practical methods to minimize food safety risks
- Understand requirements for personnel, facilities, equipment, and process controls
Course Structure
The course is organized into eight core modules followed by a final assessment. Each module ends with a short knowledge check. You must score at least 70% on each module quiz to mark it complete. Modules may be revisited at any time.
📖 Module Learning
Read each module carefully. Key regulatory text is highlighted in dark boxes. Important notes appear in colored callouts.
✅ Knowledge Checks
Each module ends with 3–5 quiz questions. Answer all questions and submit to receive feedback. Score 70%+ to proceed.
🎓 Final Assessment
A 15-question final exam covers all modules. Score 80% or higher to receive your certificate of completion.
⏱ Time Commitment
Estimated 3–4 hours total. You may pause and return to the course at any time. Progress is saved automatically.
This course is not equivalent to the required preventive controls qualified individual (PCQI) training described in 21 CFR 117.180(c)(1). However, this course may satisfy employee training requirements under 21 CFR 117.4(b)(2). Always consult your compliance officer regarding your facility's specific training obligations.
About the NPGMA
The NPGMA (NPGMA) is a leading research and extension center dedicated to ensuring the safety of foods from farm to table. Our multidisciplinary team provides science-based education, research, and outreach to help the food industry produce safe products and protect public health.
For questions about this course, contact the NPGMA at NPGMA.
Regulatory Framework & GMP Overview
Good Manufacturing Practices are the foundation of food safety regulation in the United States. This module introduces the regulatory framework and the role of GMPs in producing safe fresh produce.
What Are Good Manufacturing Practices?
Good Manufacturing Practices (GMPs) are the minimum standards required under federal law for the safe production of food. They are not optional guidelines — they are regulatory requirements with real compliance and public health consequences.
GMPs address the methods, equipment, facilities, and controls needed to produce safe, wholesome food. When properly implemented, GMPs prevent contamination, reduce hazards, and protect consumers.
Food: A raw, processed, or formulated article used or intended for use for food or drink for man or other animals. Fresh produce falls within this definition and is subject to GMP requirements when entering commerce for human consumption.
The Regulatory Landscape: FSMA and 21 CFR 117
The Food Safety Modernization Act (FSMA), signed into law in 2011, fundamentally shifted U.S. food safety regulation from a reactive to a preventive approach. FSMA granted the FDA broad new authority to regulate food safety throughout the supply chain.
Under FSMA, the FDA promulgated the Preventive Controls for Human Food Rule, codified at 21 CFR Part 117. This rule incorporates and modernizes the longstanding GMP requirements (formerly in 21 CFR Part 110) and adds new preventive controls requirements.
Key Subparts of 21 CFR Part 117
- Subpart A — General Provisions: Definitions, applicability, exclusions
- Subpart B — Current Good Manufacturing Practice: Personnel, plant and grounds, sanitary operations, facilities, equipment, processes, warehousing
- Subpart C — Hazard Analysis and Risk-Based Preventive Controls: Food safety plan, hazard analysis, preventive controls (NOT covered in this course)
- Subpart D — Modified Requirements
- Subpart F — Requirements Applying to Records
- Subpart G — Supply-Chain Program
This course focuses on Subpart B — Current Good Manufacturing Practice requirements as they apply to fresh produce processing. The preventive controls requirements in Subpart C require separate qualified individual training under 21 CFR 117.180(c)(1).
Who Must Comply?
Any facility that manufactures, processes, packs, or holds food for human consumption in the United States must comply with GMP requirements unless an exemption applies. This includes fresh produce processing operations such as:
- Fresh-cut fruit and vegetable processing
- Washing, trimming, and packaging operations
- Sprout production
- Juice operations (subject to additional requirements)
Employee Training Requirement
Each person engaged in manufacturing, processing, packing, or holding food must receive training in the principles of food hygiene and food safety, including the importance of employee health and hygiene. Training must be appropriate to the employee's duties.
Why GMPs Matter for Fresh Produce
Fresh produce presents unique food safety challenges. Unlike many processed foods, fresh produce is often consumed raw — without a cooking step to destroy pathogens. Contamination that occurs during growing, harvesting, or processing can directly cause illness.
Documented outbreaks of foodborne illness linked to fresh produce — including Listeria monocytogenes, Salmonella, E. coli O157:H7, Cyclospora, and Hepatitis A — underscore the critical importance of strict GMP adherence.
The CDC estimates that produce is responsible for approximately 46% of foodborne illnesses in the United States annually. Robust GMP implementation is essential to protecting consumers and maintaining public trust in the food supply.
Personnel Practices & Hygiene
People are the most important factor in food safety. Personnel requirements under 21 CFR Part 117, Subpart B establish standards for disease control, cleanliness, hygiene practices, and supervision to prevent human contamination of food.
Disease Control
The most critical personnel control is preventing ill workers from contaminating food. Any employee who, by medical examination or supervisory observation, is shown to have, or appears to have, an illness, open lesion, or any other source of microbial contamination must be excluded from any operations that could result in contamination of food, food-contact surfaces, or food-packaging materials.
Any person who, by medical examination or supervisory observation, is shown to have, or appears to have, an illness, open lesion (including boils, sores, or infected wounds), or any other abnormal source of microbial contamination by which there is a reasonable possibility of food, food-contact surfaces, or food-packaging materials becoming contaminated, shall be excluded from any operations which may be expected to result in such contamination until the condition is corrected.
Reportable Conditions
Employees must be trained to report the following conditions to their supervisor immediately:
- Jaundice (yellowing of skin/eyes)
- Diarrhea or vomiting
- Fever with sore throat
- Visible infected skin lesions (boils, cuts, burns with pus)
- Discharge from eyes, ears, or nose
Cleanliness Requirements
All personnel who work in direct contact with food, food-contact surfaces, and food-packaging materials must conform to hygienic practices during all work activities to the extent necessary to protect against contamination.
🙌 Handwashing
Hands must be washed thoroughly before starting work, after each absence from the workstation, and after any contamination event. Proper technique includes soap, warm water, 20 seconds of scrubbing, and drying with single-use towels.
🧤 Gloves
Gloves used in food handling must be of an impermeable material and maintained in an intact, clean, and sanitary condition. Gloves do not replace handwashing — hands must be washed before gloves are donned.
👔 Outer Garments
Suitable outer garments (aprons, smocks, coats) must be worn to protect food from contamination. Garments must be clean and changed when they become soiled or contaminated.
💇 Hair Restraints
Hair nets, beard covers, and caps must be worn to prevent hair from falling into food or onto food-contact surfaces. This applies to all personnel in food processing areas.
Prohibited Behaviors in Food Handling Areas
- Eating, chewing gum, or drinking (except in designated areas)
- Using tobacco products
- Taking snuff
- Spitting
- Wearing loose jewelry or unsecured objects that could fall into food
- Wearing nail polish or artificial nails (unless covered by gloves)
Supervision
Responsibility for assuring compliance with 21 CFR Part 117 requirements by all personnel must be clearly assigned to competent supervisory personnel. Supervisors must be trained to recognize and respond to personnel hygiene issues promptly.
Personnel training should be documented. Records should include the employee name, date of training, topics covered, and the name of the trainer. Training must be repeated when employees are assigned to new duties or when standards change.
Visitor and Contractor Control
Visitors, contractors, and other non-production personnel entering food processing areas must comply with all applicable GMP requirements, including hygiene, outer garments, and hair restraints. A visitor log should be maintained to track access to food areas.
Plant & Grounds Requirements
The physical environment of a food processing facility plays a critical role in food safety. GMP requirements for plant and grounds establish standards that prevent contamination from the exterior and structural environment.
Grounds Maintenance
The grounds around a food plant must be kept in a condition that will protect against contamination of food. The adequacy of grounds maintenance depends on conditions under which food is exposed and the nature of the potential contamination sources.
The grounds about a food plant under the control of the operator shall be kept in a condition that will protect against the contamination of food. The methods for adequate maintenance of grounds include properly storing equipment; removing litter and waste; cutting weeds; maintaining roads, yards, and parking lots; adequately draining areas; and operating systems for waste treatment and disposal.
Key Grounds Requirements
- Remove litter, waste, and refuse that could attract pests
- Cut weeds and grass that could harbor pests or serve as a contamination source
- Maintain roads, yards, and parking lots to prevent pooling of water
- Ensure adequate drainage of the grounds to eliminate standing water
- Treat and dispose of waste appropriately and in designated areas
- Store equipment properly to prevent harborage of pests
Plant Construction and Design
The plant must be suitable in size, construction, and design to allow for proper cleaning, maintenance, and sanitary operations. The physical plant design directly affects whether GMPs can be effectively implemented.
🚪 Traffic Flow
The facility layout should promote one-directional flow of product, personnel, and materials from less clean to clean areas. Cross-contamination pathways must be eliminated or controlled through physical design.
💡 Lighting
Adequate lighting must be provided in all areas including inspection stations, hand-washing areas, equipment/utensil cleaning, and toilet rooms. Light fixtures in food areas should be shatter-resistant or fitted with guards.
🌬 Ventilation
Adequate ventilation must be provided to minimize odors and vapors. Ventilation systems should provide positive air pressure in product rooms relative to outside and less-clean areas to prevent airborne contamination.
🪟 Screens & Seals
Openings such as windows, doors, and other openings must be protected against pest entry. Proper screening (16 mesh or finer) and seals around pipes, drains, and conduits prevent pest ingress.
Floors, Walls, and Ceilings
In food manufacturing areas, floors must be constructed of materials that can withstand repeated cleaning and sanitizing. Floors must be smooth, impermeable, and properly sloped to drains to prevent pooling of water.
Walls and ceilings must be constructed of materials that are smooth, non-absorbent, easily cleanable, and light-colored to facilitate inspection. Joints between walls and floors (coving) should be tightly sealed and curved to eliminate harborage areas.
Pest Exclusion and Control
Effective pest control begins with the physical plant. All reasonable precautions shall be taken to exclude pests from the processing areas. The use of insecticides or rodenticides is permitted only under precautions and restrictions that protect against contamination of food.
Pest intrusion is a major source of food contamination. Evidence of active pest infestation (droppings, tracks, gnaw marks, nesting materials) in food or food-contact areas must be reported and addressed immediately. Areas with pest evidence must be cleaned and sanitized before resuming food operations.
Separation of Operations
Food operations in the plant must be separated from areas or activities that could result in contamination. Where appropriate, separate rooms or physical barriers must be used to separate raw from ready-to-eat products, non-food chemicals from food, and waste from product.
Sanitary Operations
Effective cleaning and sanitizing programs are essential to preventing microbial contamination in fresh produce processing. This module covers GMP requirements for maintaining sanitary conditions throughout the facility.
General Maintenance
The physical facility, equipment, and utensils must be maintained in a sanitary condition. This requires ongoing monitoring, cleaning, repair, and replacement to prevent food contamination.
Buildings, fixtures, and other physical facilities of the plant shall be maintained in a sanitary condition and shall be kept in repair sufficient to prevent food from becoming adulterated. Cleaning and sanitizing of utensils and equipment shall be conducted in a manner that protects against contamination of food, food-contact surfaces, or food-packaging materials.
Cleaning and Sanitizing
Cleaning removes organic matter (soil, food residue, grease) from surfaces. Sanitizing reduces microorganisms to safe levels. Both steps are required — sanitizers are ineffective on soiled surfaces because organic matter inhibits the sanitizer's action.
The Cleaning Process
- Dry clean: Remove gross debris by scraping or brushing
- Pre-rinse: Rinse with water to remove remaining loose soil
- Apply detergent: Use appropriate cleaner at correct concentration and temperature
- Scrub: Mechanical action to remove residue
- Rinse: Remove all detergent with clean water
- Sanitize: Apply sanitizer at appropriate concentration and contact time
- Final rinse (if required): For non-food-contact surfaces or certain sanitizers
- Air dry: Allow surfaces to dry before use
Never sanitize a soiled surface. Soil neutralizes sanitizers and creates harborage areas for pathogens like Listeria monocytogenes, which can form biofilms that are extremely difficult to remove once established.
Sanitizers for Produce Processing
Approved sanitizers for use in food processing must be on the EPA-registered list and applied at concentrations specified on the label. Common sanitizers in fresh produce processing include:
💧 Chlorine (Sodium Hypochlorite)
Most common. Effective at 50–200 ppm for food-contact surfaces. pH-sensitive — most effective at pH 6.5–7.5. Monitor concentration and replace frequently.
⚗ Quaternary Ammonium (Quats)
Effective at 200 ppm for food-contact surfaces. Less affected by organic matter and pH than chlorine. Must be rinsed from food-contact surfaces.
🫧 Peroxyacetic Acid (PAA)
Effective at 80–200 ppm. Good activity at low temperatures, effective in cold water. Used in produce wash water and CIP systems.
🧪 Iodophors
Effective at 12.5–25 ppm. Leave an amber residue that serves as a visual indicator of concentration. pH-sensitive — most effective below pH 4.
Cleaning Chemicals — Safe Storage
Cleaning compounds and sanitizing agents must be free from undesirable microorganisms and must be safe and adequate under the conditions of use. They must be stored in a clearly labeled, designated area separate from food and food-contact materials.
Only those toxic materials that are required to maintain sanitary conditions, for use in laboratory testing procedures, for plant and equipment maintenance and operation, or for use in the plant's operations, shall be used or stored in the plant. These materials shall be identified, held, and used in a manner that protects against contamination of food, food-contact surfaces, and food-packaging materials.
Pest Control Programs
Effective pest control in a food processing facility requires an integrated pest management (IPM) approach: prevention through plant design, monitoring through routine inspection, and control through targeted interventions. Pest control programs must be documented and records maintained.
Sanitary Facilities & Controls
Adequate sanitary facilities are fundamental to GMP compliance. This module covers requirements for water supply, plumbing, toilet facilities, handwashing stations, and waste disposal.
Water Supply
Water that comes in contact with food or food-contact surfaces must meet the quality standards established in the National Primary Drinking Water Regulations (40 CFR Part 141). The water supply must be sufficient for the operations intended and derived from an adequate source.
Adequate quantities of water that meets the quality standards in the National Primary Drinking Water Regulations (40 CFR Part 141) must be provided for use in food manufacturing (including as an ingredient), for cleaning and sanitizing equipment and utensils, and for use in employee sanitary facilities.
Water Quality Monitoring
For fresh produce processing, water quality is critical because water contacts the product directly. Key parameters to monitor include:
- Microbial quality (total coliform, generic E. coli)
- Chlorine concentration in produce wash water
- pH of wash water (affects sanitizer efficacy)
- Turbidity and organic load of recirculated water
- Temperature
In fresh produce processing, water can spread pathogens across large quantities of product if not properly managed. Recirculated or reused water must be treated to safe microbiological levels. Monitor and document water quality routinely. Replace produce wash water when turbidity or pathogen indicator levels exceed acceptable thresholds.
Plumbing Requirements
Plumbing must be of adequate size and design, and adequately installed and maintained, to carry sufficient water quantities, properly convey sewage and liquid waste, avoid constituting a source of contamination, and provide adequate floor drainage.
Cross-Connection Control
Cross-connections between safe water supplies and potentially contaminated water must be prevented through:
- Backflow preventers at all critical connections
- Air gaps between potable water outlets and drain/waste systems
- Regular inspection of plumbing for direct connections between safe and unsafe water
Toilet and Restroom Facilities
The facility must provide employees with adequate toilet facilities, maintained in sanitary condition and in good repair. Toilet rooms must not open directly into areas where food is exposed to airborne contamination.
🚻 Adequate Number
The number of toilet facilities required is typically governed by local codes but must be sufficient for the workforce. Separate facilities for male and female employees may be required.
🔒 Self-Closing Doors
Toilet room doors must be self-closing and must not open directly into food handling areas. Vestibule areas or handwashing stations at exits are strongly recommended.
Handwashing Facilities
Handwashing facilities are one of the most critical infrastructure elements in a food processing facility. Requirements include:
- Adequate number of handwashing stations in appropriate locations
- Running water at a suitable temperature (warm water preferred)
- Effective hand-cleaning and sanitizing preparation
- Single-use sanitary hand-drying towels OR sanitary air driers
- Clearly posted handwashing instruction signs
- Conveniently located trash receptacles
Handwashing stations must be located where they are convenient for use — at the entrance to processing areas, after restrooms, near glove stations, and at other critical control points. If workers must travel far to wash hands, compliance rates drop significantly.
Rubbish and Waste Disposal
Rubbish must be conveyed, stored, and disposed of in a manner that minimizes the development of odor, minimizes the potential for waste becoming a food safety hazard, and protects against pest attraction and harboring. Waste must be removed frequently from food-handling areas.
Equipment & Utensils
Food-contact equipment and utensils are potential sources of physical, chemical, and microbial contamination. GMP requirements ensure equipment is designed, constructed, and maintained to support food safety.
Equipment Design Principles
All plant equipment and utensils must be so designed and of such material and workmanship as to be adequately cleanable, and must be properly maintained to protect food from being contaminated.
All plant equipment and utensils shall be so designed and of such material and workmanship as to be adequately cleanable, and shall be properly maintained. The design, construction, and use of equipment and utensils shall preclude the adulteration of food with lubricants, fuel, metal fragments, contaminated water, or any other contaminants.
Sanitary Design Principles (3-A Standards)
- Self-draining surfaces: No dead-legs or areas where water pools
- Smooth, non-porous surfaces: No cracks, crevices, or pits where bacteria harbor
- Accessible for cleaning: Openable, disassemblable, or CIP-compatible
- No internal threads: External threads or open channels where possible
- Minimal horizontal surfaces: Sloped or covered to prevent soil accumulation
- Compatible materials: Food-grade materials that won't corrode or leach
Acceptable Materials
Food-contact surfaces must be made of materials that are safe, non-absorbent, resistant to corrosion, and smooth. Acceptable materials include:
🔩 Stainless Steel (304/316)
The gold standard for food-contact equipment. Corrosion-resistant, non-porous, durable, and compatible with most sanitizers. Grade 316 is preferred for high-acid or high-chlorine environments.
🧴 Food-Grade Plastics
HDPE, polypropylene, and other FDA-approved polymers. Must be smooth and free of cracks. Avoid plastics that absorb odors or colors or are incompatible with sanitizers.
🪵 Wood — PROHIBITED
Wood is generally prohibited on food-contact surfaces due to its porous, absorbent nature and inability to be sanitized. Exceptions may apply for specific traditional processes only.
🔧 Lubricants
Only food-grade (NSF H1 rated) lubricants may be used on equipment where lubricant contact with food is possible. Non-food-grade lubricants used at points above food are a contamination risk.
Maintenance Programs
Equipment must be maintained in good repair and adjusted to prevent unintended contact or contamination of food. A preventive maintenance (PM) program should document:
- All equipment requiring regular maintenance
- Maintenance schedule and frequency
- Procedures for maintenance activities near food lines
- Inspection and verification steps after maintenance
- Requirements for removing and replacing worn parts (seals, gaskets, blades)
Maintenance activities introduce unique contamination risks: metal shavings, non-food-grade greases, tools, and parts left in equipment. Always conduct a thorough pre-startup inspection and cleaning after any maintenance activity in food areas. Implement a tool accountability program to track all tools entering and leaving food areas.
Temperature Controls and Instruments
Instruments and controls used to measure temperature, pH, acidity, water activity, or other conditions essential to food safety must be accurate, precise, and adequately maintained. Calibration records must be maintained for all measuring instruments.
Thermometers, pH meters, sanitizer test strips, and other measuring instruments must be calibrated against known standards at established frequencies. Out-of-calibration instruments can give false assurance and lead to unsafe conditions going undetected.
Processes & Controls
GMP process controls ensure that food is produced under conditions that prevent contamination, adulteration, and the growth of pathogens. This module addresses raw material controls, operations during processing, and critical process parameters.
Raw Material and Other Ingredient Controls
Raw materials and other ingredients must be inspected and segregated or otherwise handled as necessary to ascertain that they are clean and suitable for processing into food and stored under conditions that will protect against contamination and minimize deterioration.
Raw materials and other ingredients shall be inspected and segregated or otherwise handled as necessary to ascertain that they are clean and suitable for processing into food. Raw materials shall be stored under conditions that will protect against contamination and minimize deterioration of the raw material or ingredient.
Receiving Controls for Fresh Produce
- Inspect incoming produce for visible contamination, spoilage, pests, and off-odors
- Verify temperature of temperature-sensitive items at receiving
- Reject product that does not meet established acceptance criteria
- Maintain receiving records including supplier, lot number, quantity, and inspection result
- Segregate rejected materials from accepted product immediately
Temperature Control
Temperature is one of the most critical process controls for fresh produce safety and quality. Cooling must begin as quickly as possible after harvest or receiving to slow microbial growth and maintain product quality.
🌡 Cold Chain
Fresh produce should be maintained at ≤41°F (5°C) from receipt through distribution to inhibit the growth of most foodborne pathogens. Monitor and record temperatures throughout the cold chain.
❄️ Condensation Risk
Condensation on product surfaces promotes microbial growth and can transfer pathogens from the environment to product. Control relative humidity and temperature differentials to minimize condensation.
📊 Temperature Mapping
Conduct temperature mapping of all refrigerated storage areas to identify hot spots and ensure uniform temperature distribution. Document mapping results and corrective actions.
🔌 Equipment Failure
Establish and document procedures for responding to refrigeration equipment failure, including criteria for evaluating product safety and making hold/discard decisions.
Produce Wash Water Management
Water used to wash fresh produce is a critical control in the processing environment. Improperly managed wash water can serve as a cross-contamination vehicle, spreading pathogens from one lot to thousands of product units.
Key Wash Water Control Parameters
- Free chlorine concentration: Typically 50–200 ppm for produce washing
- pH: Maintain between 6.0–7.5 for optimal chlorine efficacy
- Temperature differential: Avoid significant temperature differences between water and produce (can cause infiltration into product)
- Turbidity: Replace water when turbidity increases (indicates organic load)
- Contact time: Adequate exposure time for the sanitizer to be effective
Cold produce immersed in warm water can draw water and potential contaminants into the product through natural pressure equalization. Always maintain wash water at a temperature equal to or warmer than the produce to minimize this risk.
Preventing Cross-Contamination During Processing
Cross-contamination occurs when pathogens are transferred from one surface, product, or person to another. Key preventive measures include:
- Physical separation of raw and ready-to-eat products at all times
- Dedicated equipment and utensils for different product types where feasible
- Traffic flow management to prevent movement of personnel from low-sanitation to high-sanitation areas
- Color-coded tools and equipment to enforce use restrictions
- Allergen control procedures if multiple products are processed
Defect Action Levels
FDA has established action levels for natural or unavoidable defects in food. However, it is not acceptable to mix adulterated product with clean product to achieve compliance. Any batch that exceeds action levels must be addressed appropriately.
Intentional adulteration is a separate but related concern. Facilities should implement food defense measures, including access controls, visitor policies, and monitoring of vulnerabilities, to protect product from deliberate contamination.
Warehousing, Distribution & Records
The final step before products reach consumers — storage, warehousing, and distribution — presents the last opportunity to prevent contamination and maintain product safety. Records provide the documentation backbone of a GMP program.
Storage Requirements
Storage and transportation of finished food must be under such conditions as will protect against physical, chemical, and microbial contamination of food, as well as against deterioration of the food and the container.
Storage and transportation of finished food shall be under such conditions as will protect against physical, chemical, and microbial contamination of food and against deterioration of the food and the container.
Storage Best Practices for Fresh Produce
- Maintain temperature and humidity at levels appropriate for each product type
- Store product off the floor on pallets or racks to allow air circulation and cleaning
- Separate incompatible products (e.g., raw from ready-to-eat, ethylene producers from sensitive items)
- Implement FIFO (First In, First Out) rotation to prevent old product from remaining in storage
- Protect product from overhead contamination sources (leaking pipes, condensation, pest activity)
- Maintain pest exclusion measures in all storage areas
Traceability and Lot Identification
Lot identification is essential for traceability — the ability to track a product forward to the consumer or back to the farm. In the event of a food safety problem, traceability enables rapid, targeted recalls that minimize consumer exposure and economic impact.
📦 Lot Coding
Each batch or lot of product must be identified with a unique code that links it to production records, ingredient lots, and processing data. Lot codes must remain on the product through distribution.
🔄 FIFO Rotation
First In, First Out rotation ensures the oldest product ships first, minimizing the risk of expired or quality-degraded product reaching consumers. Label storage locations with lot codes and receipt dates.
📋 Distribution Records
Maintain records of product distribution by lot number, including customer/consignee name, address, quantity shipped, and ship date. These records are essential for executing a recall.
↩ Recall Readiness
Facilities must have a written recall plan. The plan should include procedures for identifying affected lots, notifying customers, and recovering or disposing of affected product. Practice mock recalls annually.
Transportation Controls
During transportation, fresh produce must be protected from contamination and temperature abuse. Carriers and transport vehicles must be inspected before loading to ensure they are clean, odor-free, free of pests, and capable of maintaining required temperatures.
Before loading fresh produce, inspect the transport vehicle for: cleanliness, absence of residue from previous loads, pest activity, structural integrity, and proper refrigeration function. Document all pre-load inspections. Reject vehicles that are not suitable for food transport.
GMP Recordkeeping
Documentation is the backbone of a GMP program. Records provide evidence of compliance, enable traceability, and support corrective actions when deviations occur. While Subpart B GMPs do not specify detailed recordkeeping requirements for all areas, good recordkeeping practice is integral to effective food safety management.
Key Records to Maintain
- Employee training records (topics, dates, trainer signatures)
- Sanitation logs (cleaning and sanitizing activities with dates, times, operators)
- Water quality monitoring records
- Temperature monitoring logs (cold storage, receiving)
- Pest control inspection reports and activity records
- Equipment calibration records
- Receiving and inspection records
- Supplier approval records
- Distribution and traceability records
Records must be completed at the time the activity occurs — not reconstructed after the fact. Records should be legible, indelible, and dated. For electronic records, appropriate controls for accuracy and authenticity apply. The adage in regulatory compliance: "If it wasn't documented, it didn't happen."
Final Assessment
Congratulations on completing all eight modules. This final assessment covers all course content. You must score 80% or higher (12 of 15 correct) to receive your Certificate of Completion.
Course Complete!
You have successfully completed the Current Good Manufacturing Practices course. Your certificate is ready below.
It is not equivalent to PCQI training under 21 CFR 117.180(c)(1).