New manufacturing facility requirements for infant formulas and human milk fortifiers

A guidance document for infant formula and human milk fortifier manufacturers
2021

Table of Contents

• 1.0 Introduction
  • 1.1 Purpose
  • 1.2 How to read this guide
• 2.0 Premises
  • 2.1 Outside property and buildings
  • 2.2 Building interior – design, construction, and maintenance
  • 2.3 Waste disposal and drainage
  • 2.4 Lighting
  • 2.5 Air quality and ventilation
  • 2.6 Sanitary facilities - employee facilities (e.g. washrooms, lunch room, and sanitizing stations)
  • 2.7 Equipment cleaning and sanitizing facilities
  • 2.8 Water, steam or ice quality
    • 2.8.1 Water supply
    • 2.8.2 Steam
    • 2.8.3 Adequacy of microbiological and/or chemical safety of the water, ice and steam
• 3.0 Transportation and storage (including purchasing and receiving)
  • 3.1 Food carriers (conveyance)
  • 3.2 Temperature control
  • 3.3 Storage
• 4.0 Equipment and utensils
  • 4.1 Design and installation
  • 4.2 Equipment maintenance and calibration
• 5.0 Personnel
  • 5.1 General food hygiene training
  • 5.2 Technical training
• 6.0 Sanitation and pest control
  • 6.1 Sanitation
  • 6.2 Pest control program
• 7.0 Recall system
  • 7.1 Product code identification
  • 7.2 Records
• 8.0 Documentation and records
• 9.0 Process validation, qualification and control
• 10.0 Additional information relevant to the control of infant formula and human milk fortifier products

1.0 Introduction

Pursuant to Section 4 and Section 7 of the Food and Drugs Act (FDA), all foods, including infant formulas and human milk fortifiers, offered for sale in Canada must be safe for human consumption, and manufacturing of foods under unsanitary conditions are prohibited.

Division 25 of the Food and Drug Regulations (FDR) requires petitioners to submit a premarket notification for a new infant formula or human milk fortifier, or those that have undergone a major change in composition, manufacturing, or packaging. The premarket submission must include details of the manufacturing process and quality control procedures used throughout processing, pursuant to Section B.25.046 (2) (g) (for infant formula) and Section B.25.011 (h) (for human milk fortifier) of the FDR.

This document provides guidance on the information required when an infant formula or human milk fortifier is manufactured in a new facility, or an existing facility in which it has not been previously manufactured. This guide should be used in conjunction with the Guide for the Preparation of Infant Formula and Human Milk Fortifier Premarket Submissions and Good Manufacturing Practices for Infant Formula (GMPs).

Upon completion of a premarket review of a new infant formula or human milk fortifier submission, and if Health Canada has no further questions or objections, a letter will be issued for the sale of the infant formula or human milk fortifier in Canada.

All infant formula and human milk fortifier manufacturers are required to be licensed under the Safe Food for Canadians Act (SFCA) and Safe Food for Canadians Regulations (SFCR) to conduct activities including manufacturing, labelling, packaging, exporting, importing or sending infant formula or human milk fortifier across provincial or territorial boundaries. After obtaining your letter from Health Canada, please consult MyCFIA and the What to Consider Before Applying for a Safe Food for Canadians licence to apply for the Safe Food Canadians licence.

In this document, 'manufacturer' refers to a manufacturer of infant formula or human milk fortifier.

1.1 Purpose

The purpose of this guide is to expand on the guidance in the GMPs, to help manufacturers producing infant formula or human milk fortifier in a new facility.

It is aimed at helping manufacturers prepare a premarket submission to demonstrate that infant formulas and human milk fortifiers meet regulatory requirements and are manufactured in safe and hygienic conditions.

1.2 How to read this guide

Each section of this guide describes the information required for specific aspects of a new manufacturing facility in preparation of a premarket submission, including: premises, transportation and storage, equipment, personnel, sanitation, recall system and records, as well as process validation and controls.

It is the manufacturer's responsibility to clearly demonstrate the required information using appropriate means including but not limited to, pictures, site plan, aerial photographs, diagrams, or design plans, with appropriate descriptions or documentation such as records, protocols, standard operating procedures (SOP).

Where relevant information in other documents, such as the Guide for the Preparation of Infant Formula and Human Milk Fortifier Premarket Submissions and the GMPs, should be considered, this guide specifies which sections in these respective documents should be consulted.

2.0 Premises

This section should be read in conjunction with Section 1 and Section 3.2 of the GMPs where the requirements for manufacturing premise are outlined, specifically for its conditions, construction, maintenance, and operation, such that contamination of infant formulas or human milk fortifiers is controlled, or prevented from microbiological, physical, chemical, allergenic, environmental and physical hazards.

2.1 Outside property and buildings

Recommended types of documentation: Pictures, site plan and aerial photographs, with descriptions to show the location of all buildings, and property boundaries, roadways, fences, ancillary structures including distances from other industrial, commercial and residential buildings, so that the location and the physical details of the facility, including design, construction, and maintenance, are clearly demonstrated.

Manufacturers must demonstrate that:

• The location of the facility does not contribute to the contamination of the infant formula or human milk fortifier;
• Roadways are properly graded, compacted, dust proofed, and drained;
• Surroundings are adequately drained (drain spouts located at ground level are directed away from the building facility);
• The building exterior is designed, constructed and maintained to prevent entry of contaminants and pests (e.g. openings are protected, air intakes are appropriately located, and the roof, walls and foundation are maintained to prevent leakage); and
• The roof of a powdered infant formula or human milk fortifier facility is kept clean to minimize powder build-up, if the air intake supply originates on the roof and the dryer exhaust stack exits on the roof.

2.2 Building interior – design, construction, and maintenance

The interior of the buildings where infant formulas or human milk fortifiers or their ingredients are manufactured, processed, stored or prepared must be appropriately designed and constructed. Buildings must be maintained in good condition to prevent contamination, and adequately sized and laid out to enable the controlled movement of personnel, equipment or materials.

Recommended type of documentation: Design plans including layout, site plans, and floor plan for each level of the facility and process flow diagram (with descriptions).

Manufacturers must demonstrate that:

• Internal structures such as floors, walls, doors, windows, ceilings, overhead and other structures in rooms are constructed of materials that are durable, impervious to moisture, smooth, cleanable, easy to disinfect, and suitable for the production conditions in the area;
• Floors, walls and ceiling joints are sealed and angles are coved where appropriate, to prevent contamination, permit effective maintenance, and facilitate cleaning and sanitizing;
• Floors, walls, ceilings and openings in facility are made of safe and suitable construction materials according to the Guidance for Food Establishments Concerning Construction Materials and Packaging Materials and Non-Food Chemicals;
• Floors and drains should permit liquids to drain rapidly to trapped outlets and allow ready access for maintenance, cleaning and disinfection;
• Windows are sealed or equipped with close fitting screens, are constructed of suitable materials, and are well protected to avoid breakage of glass that would lead to the contamination of infant formula or human milk fortifier;
• Doors have smooth, non-absorbent surfaces and are close fitting and self-closing, where appropriate, and are easy to clean and disinfect;
• Food contact surfaces are: in sound condition, durable, and easy to clean, maintain and disinfect;
  • They are made of smooth, non-absorbent materials, and are inert to the food, detergents, and disinfectants under normal operating conditions;
• Equipment and areas surrounding them are easily accessible for maintenance, cleaning, and sanitizing activities including inspection;
• Hard-to-reach areas are sealed to prevent build-up of contaminants;
• The size and layout of rooms provides adequate space and can accommodate the physical and operational separation of incompatible operations where cross-contamination may result;
  • Separate areas are provided for handling of raw materials, manufacturing products, packaging and labelling, storage and shipping operations;
• Separate areas or other systems of separation are provided for the holding of quarantined or rejected raw materials, in-process materials, final product and storage of retained samples;
• Production areas where products and materials are exposed are effectively segregated from storage areas, lunchrooms, washrooms and other service areas;
• Laboratories that conduct microbiological and pathogen testing are separate from food preparation areas;
• Separate facilities are provided for cleaning and sanitizing activities which occur separately from infant formula or human milk fortifier preparation activities or storage;
• Movement of personnel, equipment and materials (traffic pattern and process flow) within the building minimizes cross-contamination and provides hygienic operations (considers flow of raw materials, in-process products, finished products, workers, including to and from locker rooms, washrooms and lunchrooms, waste materials, personnel, chemicals, allergens, equipment and waste, including change-over or buffer and transition zones). Examples include restricted and controlled entrances for access of personnel, equipment and materials through appropriately designed interfaces such as buffer zones with airlocks or UV tunnels for entry of raw materials and other items into high hygiene areas;
• The dry processing areas where operations from the drying step up to the filling and hermetic closure of containers are performed are maintained as high hygiene areas;
• Areas with different levels of hygiene control or zoning, such as raw materials and finished products or wet and dry processing areas, are separated to minimize cross-contamination through appropriate measures such as: physical separation, e.g. walls or partition or buffer zone, location (distance), air flow (positive air pressure) or separation in time, with suitable cleaning and disinfection between uses or developing and implementing SOPs regarding traffic flow; and
• In microbiologically sensitive areas, positive air pressure is maintained by appropriately designed air delivery system to prevent entry of unfiltered air i.e. complementary to physical separation, known as zoning in high hygiene areas.

2.3 Waste disposal and drainage

Manufacturers must have adequate waste disposal equipment and facilities, adequate training of designated employees for waste disposal, as well as timely disposal of waste in a safe manner. The drainage and sewage systems must be designed and controlled to prevent contamination.

Recommended type of documentation: Diagrams or design plans with descriptions, documents from qualified personnel or other regulatory or third parties.

Manufacturers must demonstrate that:

• Drainage and sewage systems are equipped with appropriate traps and vents;
• Appropriate measures are in place to prevent backflow, cross connection and backup of sewer gases;
• Facilities are designed and constructed to prevent contamination of products or water supply from the sewage system and any other waste effluent system into the facility;
• Effluent or sewage lines do not pass directly over or through production areas unless they are controlled to prevent contamination;
• Adequate facilities and equipment are provided and maintained for the storage of waste and inedible material prior to removal from the establishment;
• The facilities are designed to prevent contamination, such that:
  • Containers for waste and/or dangerous substances, are specifically identifiable, suitably constructed and, where appropriate, made of impervious material;
  • Containers used to hold dangerous substances are in a secure room or are lockable to prevent malicious or accidental contamination of infant formula or human milk fortifier;
• Waste and inedible materials are physically segregated from incoming materials and disposed of by safe and effective procedures and by trained personnel, where appropriate disposal records are maintained;
• Dry drains are used, if applicable, to prevent the presence of water residues which could lead to growth and spread of microorganisms including relevant pathogens;
• In wet areas, or where applicable, appropriately designed hygienic drains are used;
  • Drains are of adequate number and size, appropriately located, designed and installed so that they are cleanable and maintained in good repair and can be sanitized; and
• There is an action plan ready to mitigate the risk of contamination of the product if a problem with the drainage system occurs, including that production will not re-start until the drainage system is fixed.

2.4 Lighting

The lights used in areas where infant formula or human milk fortifier are produced, cleaned, inspected, examined, screened, or exposed must be of appropriate source, intensity and colour, for safety and to avoid contamination.

Recommended type of documentation: Pictures, diagrams, or design plans, with descriptions.

Manufacturers must demonstrate that:

• Lighting (natural or artificial) used is appropriate for effectively conducting intended activities (e.g. inspecting the interior of a bulk tank) according to the CFIA guidance in Lighting in an Establishment;
• The lighting does not alter the infant formula, human milk fortifier or ingredient colour or cause nutrients to deteriorate or affect quality;
• The lighting allows easy identification of raw materials, packaging, labelling, in-process materials, and finished products;
• The lighting permits the easy reading of instruments and controls necessary in processing, packaging, and laboratory analysis; and
• Light bulbs and fixtures located in or adjacent to areas where there are exposed raw materials, in-process materials, or bulk (unpackaged) finished product or packaging materials, are of a safety type, or are protected to prevent contamination of the products in case of breakage.

2.5 Air quality and ventilation

The facility where infant formulas or human milk fortifiers are made must have air/ventilation systems that provide good air exchange. They must be designed to provide positive air pressure to avoid contamination in microbiologically sensitive areas, control temperature, maintain the right level of humidity, and prevent any intake of chemical, biological or physical contaminants. They must be accessible for disassembling, cleaning, and maintenance.

Recommended type of documentation: Diagrams or design plans, with descriptions.

Manufacturers must demonstrate that:

• Appropriate measures are in place, which may include the use of an air delivery system with filtration, e.g. sterile air filter at point-of-use in the air stream to minimize the potential for contamination of: raw materials, in-process materials, final infant formula or human milk fortifier and packing materials, equipment, and infant formula contact surfaces;
• Ventilation provides sufficient air exchange to prevent unacceptable accumulations of steam, condensation, or dust, and to remove contaminated air;
• Air handling and ventilation units are constructed, designed, installed, cleaned, and maintained in such a way as to ensure the integrity of the zoning principles, for example, appropriate design and installation of the filters, to avoid any bypass of unfiltered air, air flow from contaminated areas to clean areas, and accumulation of condensates;
• Ventilation openings are equipped with closed fitting screens or filters to prevent the intake of contaminated air;
• Filters are replaced or cleaned and disinfected regularly in a manner that does not contaminate the processing environment (filter maintenance and monitoring program);
• Air temperature and relative humidity are maintained in the dry areas at levels to ensure raw materials and products are not affected;
  • Deviations from established air temperatures and relative humidity are investigated, as well as corrected;
• The ventilation system is easily accessible and can be properly disassembled for cleaning, maintenance, and inspection;
• The delivery systems of materials such as gases are regularly monitored, maintained, and controlled to prevent contamination; and
• There are compressed air and filter maintenance and monitoring programs.

2.6 Sanitary facilities - employee facilities (e.g. washrooms, lunch room, and sanitizing stations)

Manufacturers must have the necessary sanitary facilities for the number of employees working in the facility. The manufacturer must also ensure that an appropriate degree of personal hygiene is maintained to avoid contaminating infant formulas, human milk fortifiers or ingredients.

Recommended type of documentation: Diagrams or design plans, with descriptions.

Manufacturers must demonstrate that:

• The sanitary facilities can accommodate the number of employees working on site;
  • With sufficient and adequate hand washing and sanitizing stations, washrooms, showers, drinking water stations, lunchrooms and change rooms;
• The sanitary facilities are designed to be readily accessible, easily maintained, appropriately equipped, and can accommodate concurrent use by a number of employees;
• Washrooms have hot and cold potable running water, soap dispensers, soap, sanitary hand drying equipment or supplies, and a cleanable waste receptacle;
• Washrooms, lunchrooms, and change rooms are provided with adequate floor drainage and ventilation, and are maintained in a manner to prevent contamination;
• Washrooms, lunchrooms, and changing rooms are separated from and do not open directly into food processing areas;
• Cleaning and sanitizing stations for hands and footwear are installed and maintained to prevent the contamination of the infant formula or human milk fortifier or ingredients;
• There is an adequate number of conveniently located and accessible hand washing and sanitizing stations which are;
  • Close to product handling areas;
  • Provided with sensor activated stations, hot and cold potable running water, soap dispensers, germicidal soap, sanitary hand drying equipment or supplies, and a cleanable waste receptacle; and
  • Use solutions that allow for the effective removal of waste and contaminants when the stations do not use water;
• Potable water is used in the hand and footwear sanitizing stations;
  • Sanitizing chemicals used are approved, appropriate for use, and maintained at the concentration needed to be effective;
• Processing areas are provided with an adequate number of conveniently located hand washing stations with trapped waste pipes to drains;
• The water temperature is warm enough to soften residues on hands and allow the soap to produce the lather needed to remove waste and contaminants but is comfortable for the hands; and
• The water pressure is strong enough to allow for dirt and contaminants to be easily removed from the hands.

2.7 Equipment cleaning and sanitizing facilities

Section 3.2 of the GMPs requires manufacturers to have designated areas or rooms for cleaning and sanitizing equipment. The designated areas or room for cleaning and sanitizing equipment must be located and operated in a manner to avoid contamination of infant formula or human milk fortifier.

Recommended type of documentation: Pictures with descriptions.

Manufacturers must demonstrate that:

• Sanitizing facilities are:
  • Constructed of corrosion resistant material that allows to be easily cleaned; and
  • Have potable water at temperatures appropriate for the cleaning chemicals used;
• Equipment cleaning and sanitizing facilities are adequately separated from food storage, processing, and packaging areas to prevent contamination.

2.8 Water, steam or ice quality

Section 3.5 and Section 3.8 of the GMPs require potable water to be used as an ingredient, for cleaning food contact surfaces, operating equipment use to hold, transport and process infant formula. Ice and steam when used in areas where they come in direct contact with products, ingredients or equipment must be derived from potable water. Non-potable water used for other purposes must not be a source of contamination.

Recommended type of documentation: Procedures, SOPs, records.

Manufacturers must demonstrate that:

• Potable water used in the manufacturing of infant formula or human milk fortifier meets the requirements of Health Canada's Guidelines for Canadian Drinking Water Quality;
  • If manufactured in a foreign country, manufacturers must outline how the standards in the foreign country meet or are equivalent to those of Canada;
• Water and ice are analyzed by the manufacturer at a frequency adequate to confirm its potability;
• Water from sources other than municipal supplies are treated by appropriate method (e.g. filtration, use of ultraviolet light) and tested to ensure potability;
  • The treatment selected should address all potential hazards and the level of risk associated with those hazards;
• The sources of water and the water treatment procedures used are identified; and
• Ice used as an ingredient or in direct contact with the infant formula or human milk fortifier is made from potable water and is protected from contamination.

Documentation on water treatment should include:

• Descriptions of the roles of personnel responsible for implementation and activities performed;
• Concentration, method and frequency of chemicals used, their handling and application; and
• Testing procedures, including verification that water treatment is appropriate and effective.

The suitability/safety of water treatment chemicals for use in an infant formula or human milk fortifier establishment must be provided, when they are used, according to the Reference Listing of Accepted Construction Materials, Packaging Materials and Non-Food Chemical Products Database and Incoming ingredients, materials and non-food chemicals.

2.8.1 Water supply

Sections 3.5 and 3.8 of the GMPs require that the manufacturer designs, constructs, and maintains water storage facilities, including the control and monitoring of the chemical and physical treatment of the water supply to minimize contamination.

Recommended type of documentation: Design plans with descriptions, SOPs, protocols, procedures and records.

Manufacturers must demonstrate that:

• There are no cross-connections between potable and non-potable water supplies;
• All hoses, taps or other similar sources of possible contamination are designed to prevent back-flow or back-siphonage;
• Where it is necessary to store water, storage facilities are adequately designed, constructed, and maintained to prevent contamination;
• The volume, temperature and pressure of the potable water are adequate for all operational and cleanup demands;
• The chemical treatment is monitored and controlled to deliver the desired concentration and to prevent contamination;
• Actions are taken to prevent the contamination due to failure of the municipal water supply to the establishment;
• Where used, filters are kept effective and maintained in a sanitary manner; and
• Recirculated water is treated, monitored, and maintained as appropriate for the intended purpose and has a separate distribution system which is clearly identified.

2.8.2 Steam

Recommended type of documentation: Records, SOPs, protocols and procedures.

Manufacturers must demonstrate that:

• Boiler treatment chemicals used are safe and suitable according to Guidance for Establishments Concerning Construction Materials and Packaging Materials and Non-Food Chemicals;
• Boiler feed water is tested regularly and the chemical treatment is controlled to prevent contamination;
• The steam supply is generated from potable water and the steam pressure available is adequate to meet operational requirements (such as cleaning and sanitizing activities, thermal processing);
• Only culinary steam is used in direct contact with the infant formula or human milk fortifier and contact surfaces, e.g. during Aseptic Processing and Packaging System (APPS) processing, or other direct steam injection; and
• Culinary steam must comply with the 3-A Sanitary Standards, No. 60903.

Refer to CFIA guidance Culinary steam and Health Canada guidelines for Incidental Additive Submissions for additional guidance for steam that comes in direct contact with the infant formula, human milk fortifier or ingredients and product contact surfaces.

2.8.3 Adequacy of microbiological and/or chemical safety of the water, ice and steam

Recommended type of documentation: Records.

Manufacturers must demonstrate the adequacy of the microbiological and/or chemical safety of the water, ice and steam supply by including records on:

• Water (municipal or in house) and ice potability, identifying water source, sample site, analytical results, analyst and date;
• Water treatment, identifying method of treatment, sample site, analytical results, analyst and date;
• Water reuse;
• Boiler feed water treatment, identifying method of treatment, analytical results, date and analyst, where applicable; and
• Follow up on out of specification findings for microbiological or chemical safety of water, ice and steam, where applicable.

Additional information is available on the CFIA website:

• Water for use in the preparation of food;
• Ice used in the preparation of food;
• Sampling procedures;
• Preventing water backflow.

3.0 Transportation and storage (including purchasing and receiving)

This section should be read in conjunction with Sections 3.7 and 3.8 of the GMPs which describe the required measures to protect infant formula, human milk fortifier or their ingredients from potential sources of contamination or damage.

3.1 Food carriers (conveyance)

Recommended type of documentation: Protocols, procedures or SOPs, and records.

Manufacturers must demonstrate that:

• Carriers are designed, constructed, used, and maintained in a manner to prevent contamination of infant formula, human milk fortifier, or ingredients;
• Carriers are cleaned, sanitized, and maintained in a sanitary condition, with;
  • Bulk transport tankers regularly drained for cleaning;
  • The demonstrated adequacy of cleaning and sanitizing;
  • A written cleaning and sanitizing procedure for equipment such as bulk carriers;
• Carriers are inspected and verified by the manufacturer on receipt and prior to loading to ensure that;
  • They are free from contamination;
  • Suitable for the transportation of infant formula, human milk fortifier, or their ingredients;
• Carriers are equipped with instruments that control, indicate, and record temperature and humidity, where necessary;
• Loading and unloading site of the establishment is sealed to prevent pests from coming into contact with the food; and
• Carriers or other equipment used for transportation of infant formula, human milk fortifier, or ingredients, intermediates, and finished products within the processing operation are carefully maintained.

3.2 Temperature control

Recommended type of documentation: Records.

Manufacturers must demonstrate that:

• Carrier temperature is maintained in a manner to prevent contamination of food;
• Ingredients requiring refrigeration are transported between 0 and 4°C;
• Frozen ingredients are transported at temperatures that do not permit thawing, i.e. ≤-18°C;
• Transportation temperatures are appropriately monitored and recorded to ensure proper maintenance of ingredients whether refrigerated or frozen; and
• Finished infant formula or human milk fortifier is transported under conditions which prevent microbiological, physical and chemical deterioration.

3.3 Storage

Recommended type of documentation: Protocols, procedures, or SOPs, and records.

Manufacturers must demonstrate that:

• Frozen ingredients and ingredients requiring refrigeration are stored at ≤-18°C and 4°C, respectively, and;
  • Storage temperatures are appropriately monitored and recorded to ensure proper temperatures for refrigerated and frozen ingredients;
• Ingredients and packaging materials are handled and stored in a manner to prevent damage and/or contamination;
• Rotation of ingredient and packaging material is controlled to prevent deterioration and spoilage;
• Humidity sensitive ingredients and packaging materials are stored under appropriate conditions to prevent deterioration, and;
  • Temperature and humidity conditions are monitored and recorded to ensure that the product is appropriately stored;
• All non-food chemicals are safe and suitable for use in infant formula facilities according to the Guidance for Food Establishments Concerning Construction Materials and Packaging Materials and Non-Food Chemicals;
  • List of all non-food chemicals used in the facility is kept;
• Non-food chemicals are stored in designated areas such that there is no possibility for cross contamination of food or food contact surfaces;
  • Where required for ongoing use in food handling areas, these chemicals are stored in a manner that prevents contamination of food, food contact surfaces, or packaging materials;
• All chemicals are;
  • Stored and mixed in clean, correctly labelled containers;
  • Dispensed and handled only by authorized and properly trained personnel;
  • Received, handled and stored in a dry, adequately ventilated area as outlined in Section 3.5 of the GMPs; and
• Finished products are stored and handled under conditions to prevent deterioration and damage, e.g. by controlling stacking heights, handling to minimize forklift damage.

Additional information is available via CFIA's preventive control documents, i.e. Incoming ingredients, materials and non-food chemicals and Supplier food safety assurance program.

4.0 Equipment and utensils

This section should be read in conjunction with Section 3.2 and Section 3.9 of the GMPs where the manufacturer's responsibility is outlined with respect to the equipment used in the manufacturing, processing, storage or packaging of infant formula. The equipment must be designed, operated and maintained in a manner to prevent contamination and to enhance the safety and quality of the product. It also outlines that the manufacturer must ensure that all processing systems, retort/aseptic processing systems are validated by a process engineer or a process authority, where appropriate.

4.1 Design and installation

Recommended type of documentation: Protocols, procedures, or SOPs, and records.

Manufacturers must demonstrate that:

• Equipment and utensils are designed, constructed, and installed to;
  • Be accessible, durable and movable or capable of being disassembled, for cleaning, sanitizing, maintenance, monitoring, and inspection;
  • Permit proper drainage and where appropriate, is connected directly to drains;
  • Have effective means to control, indicate, record, and monitor temperature, humidity, airflow, and any other conditions likely to have an effect on the safety or suitability of infant formula or human milk fortifiers, where applicable;
• Where necessary, equipment is exhausted to the outside of the facility to prevent excessive condensation;
• Equipment and utensils used to handle inedible material are not used to handle edible material and are clearly identified;
• Food contact surfaces of equipment and utensils are smooth, non-corrosive, non-absorbent, non- toxic, free from pitting, cracks or crevices, and are made of materials that can withstand repeated cleaning and sanitation; and
• Coatings, paints, chemicals, lubricants, and other materials used for food contact surfaces or equipment where there is a possibility of contact with infant formula/human milk fortifier or ingredients, packaging material, and in-process material are safe and appropriate for use, according to the Guidance for Establishments Concerning Construction Materials and Packaging Materials and Non-Food Chemicals.

4.2 Equipment maintenance and calibration

Manufacturers are responsible to maintain a list of critical equipment, devices, or instruments requiring regular maintenance and calibration, identification of equipment maintenance activity and frequency, date, person, and reason for activity.

Manufacturers must demonstrate that:

• Maintenance and calibration of equipment is performed by appropriately trained personnel;
• The maintenance and monitoring of processing systems using air directly, filters, metal detectors, and compressed air equipment are appropriate;
• Maintenance of critical equipment including the identification of equipment maintenance activity and frequency, date, person, and reason for activity;
• An effective written preventive maintenance program is in place to ensure that equipment and components that may impact food safety operate as intended, for example;
  • Preventative maintenance is scheduled for components such as gaskets, replacement of seals on critical equipment such as an Aseptic Sterilizer;
• Calibration methods and frequencies for equipment monitoring and controlling devices that may impact food safety are appropriate;
  • The maintenance procedures and frequencies, such as equipment inspection, adjustment and replacement of parts which are based on the equipment manufacturer's manual or equivalent, or are based on operating conditions that could affect the condition of the equipment; and
• Calibration information expected for equipment includes the identification of equipment, activity and frequency, date, person responsible, and calibration results.

5.0 Personnel

This section should be read in conjunction with Section 3.3 of the GMPs where manufacturer's responsibility is outlined with respect to having programs in place that meet the GMP requirements for personnel training, health, and hygiene.

5.1 General food hygiene training

Recommended type of documentation: Protocols, procedures or SOPs, and records.

Manufacturers must demonstrate that:

• A written training program for personnel is in place and up-to-date;
• Appropriate training in personal hygiene and hygienic handling of food is provided to all food handlers at the beginning of their employment;
• The original food hygiene training is reinforced and updated at appropriate intervals;
• All persons wash their hands upon entering food handling areas, before starting work, after handling contaminated materials, after breaks, and after using toilet facilities;
• Where necessary to minimize microbiological contamination, employees use disinfectant hand dips;
• Protective clothing, hair covering, footwear and/or gloves, appropriate to the operation that the employee is engaged in, are worn and maintained in a sanitary manner, for example, employees in production areas wear effective hair coverings;
• Any behaviour which could result in contamination of food, such as eating, use of tobacco, chewing gum, or unhygienic practices such as spitting are prohibited in food handling areas;
• All persons entering food handling areas remove jewelry and other objects which may fall into or otherwise contaminate food;
  • Jewelry, including wedding bands, and medical alerts which cannot be removed, are covered over;
• Personal effects and street clothing are not kept in food handling areas and are stored in a manner to prevent contamination;
• Access of personnel and visitors is controlled to prevent contamination;
  • The traffic pattern of employees prevents cross-contamination of the product;
• The manufacturer has and enforces a policy to prevent personnel known to be suffering from, or known to be carriers of a disease transmissible through food, from working in food handling areas;
• The manufacturer requires that employees advise management when they are suffering from a communicable disease likely to be transmitted through food; and
• Personnel having open cuts or wounds do not handle food or food contact surfaces unless the injury is completely protected by a secure waterproof covering such as rubber gloves.

5.2 Technical training

Recommended type of documentation: Protocols, procedures, or SOPs, and records.

Manufacturers must demonstrate that:

• A written training program for personnel is in place and up-to-date;
• Training is appropriate for the complexity of the manufacturing process and the tasks assigned, for example;
  • Personnel are trained to understand the importance of the critical control points for which they are responsible, the critical limits, the procedures for monitoring, the action to be taken if the limits are not met and the records to be kept;
• Personnel of all departments involved in the design, production, testing, storage, and distribution of infant formula shall be adequately qualified by education, training and experience to competently conduct the responsibilities with which they are charged;
• Personnel responsible for maintenance of equipment impacting food safety, have been appropriately trained to identify deficiencies that could affect product safety and to take the appropriate corrective action;
• Personnel performing maintenance on specific equipment are appropriately trained;
• Personnel and supervisors responsible for the sanitation program are appropriately trained to understand the principles and methods required for effective cleaning and sanitizing;
• Process operators are given adequate training under close supervision before they are allowed to work independently with new technologies and new work processes introduced to processing areas; and
• Additional training is provided as necessary to ensure current knowledge of equipment and process technology, such as specific technical training or apprenticeship programs.

6.0 Sanitation and pest control

This section should be read in conjunction with Section 3.5 of the GMPs where manufacturer's responsibility is outlined with respect to sanitation and pest control.

6.1 Sanitation

Recommended type of documentation: Protocols, procedures, or SOPs, and records.

Manufacturers are required to:

• Implement a written sanitation program which includes cleaning procedures for premises and equipment as well as instructions on the sanitary handling of all materials and equipment used in production;
• Establish effective supervisory procedures to ensure that critical procedures such as manual cleaning, cleaning-in-place systems operation, and equipment maintenance are conducted to established protocols and standards; and
• Implement written procedures for periodic monitoring of the environment.

The CFIA Cleaning and Sanitation Program should be consulted for additional information.

Manufacturers must demonstrate that:

• A written cleaning and sanitation program is in place and implemented for;
  • All equipment, which includes the name of responsible person, the frequency of the activity, chemicals used and their quantity/concentration, temperature requirements, and the procedures for cleaning and sanitizing;
  • Premises, production and storage areas, which specifies areas to be cleaned, method of cleaning, person responsible and the frequency of the activity;
    • Special sanitation and housekeeping procedures required during production are specified within the document, such as removal of product residues during breaks, cleaning and storage of equipment, or drying of certain equipment or areas prior to being used;
• Written procedures are implemented for periodic monitoring of environmental quality in processing and storage areas, and for the prevention of environmental contamination;
• Cleaning and sanitizing equipment is designed for its intended use and is properly maintained;
  • Automated cleaning systems such as Clean-In-Place (CIP) systems are validated to ensure their effectiveness in achieving cleaning and sanitation objectives and in preventing contamination;
• Chemicals are appropriately used according to the Guidance for Food Establishments Concerning Construction Materials and Packaging Materials and Non-Food Chemicals;
• The effectiveness of the sanitation program is monitored and verified and adjusted accordingly, for example by having in place routine inspection of premises and equipment, microbiological testing; and
• Sanitation activities include the date, person responsible, the findings, corrective action taken, and microbiological test results, where appropriate.

6.2 Pest control program

Manufacturers must:

• Have an effective pest (e.g. birds, rodents, and insects) control program in place for the premises and equipment which;
  • Is documented and implemented;
  • Includes approval and control of designated pesticide products and pest control contractors;
• Keep their facility in good repair and condition, and create an environment that prevents pest access, harbourage and infestation; and
• Have in place methods to monitor, detect and take corrective action when pests are found in their facility.

The CFIA preventive control guidance on Pest Control should be consulted for additional information.

Recommended type of documentation: Protocols, procedures, or SOPs, and records as specified below.

Manufacturers must demonstrate that:

• Procedures, protocols or SOPs are in place for preventing pest access and to eliminate potential breeding sites, conditions that encourage pest harbourage and infestation;
• Monitoring and detecting activity is conducted by regularly scheduled inspection to examine the premises for evidence of pest infestation;
• Pest infestation control procedures are in place and conducted by a qualified person, and when pests are present;
  • The cause of infestation is identified;
  • Appropriate corrective actions are taken to prevent reoccurrence;
• Pesticides are permitted for use, and are registered under the Pest Control Products Act and the Pest Control Products Regulations are used in accordance with the label instructions (See Health Canada's Public Registry); and
• Treatment of equipment, premises or ingredients to control pests is conducted not to exceed the maximum residue limit prescribed in the FDR by, for example, limiting the number of fumigation treatments per lot.

The following pest control records should be submitted at the minimum:

• The name of the person responsible for pest control for the premises;
• A map indicating each trap location;
• The type and frequency of inspection to verify the effectiveness of pest control program in place;
• Results of the inspection;
  • Whether or not the infestation of pests was identified;
  • When the infestation was identified;
    • How it was identified, e.g. findings in traps;
    • Nature of infestation, e.g. type of pests, severity of infestation;
    • Cause of infestation, e.g. deteriorated baseboard due to moisture
    • Name of the pest control company or the person responsible for controlling pests;
    • Pest control activities that took place, specifying for each activity;
      • Pesticide used, as well as its concentration;
      • Method and location of application;
      • Date and time of application;
      • Frequency of application;
      • Person who applied the pest control product; and
    • Subsequent monitoring and eradication activities that took place, specifying each activity for the original pest control activity.

7.0 Recall system

This section should be read in conjunction with Section 3.17 of the GMPs where the requirements for recall system are outlined.

Manufacturers must:

• Have a written protocol for removal of unsafe infant formula products from the market;
• Have procedures in place to respond to failure, assess the impact of deviations on food safety and suitability, and report to the relevant regulatory authorities; and
• Document, maintain, and modify recall procedures based on the findings of mock or actual recall.

CFIA Recall Procedure: A guide for food businesses should be consulted for additional information.

Recommended type of documentation: Protocols, procedures, or SOPs, and records.

Manufacturers must demonstrate that:

• There is a written protocol in place that permits a complete and rapid recall of any lot of infant formula or human milk fortifier, including;
  • Tracking, analysis, any corrective actions taken and recording of product complaints;
• There is capacity and capability to identify, control, trace, and reconcile individual lots, e.g. by conducting mock recalls;
• There is a written recall procedure in place, clearly defining responsibilities for:
  • Evaluating health risks;
  • Making recall decisions;
  • Communicating with government officials and other external parties;
  • Implementing and reporting results of the recall;
  • Immediate notification of the CFIA's Recall Coordinator in the region /area where the manufacturer is located, if the CFIA is not aware of the recall; and
    • In some cases through the regulatory agency having jurisdiction.

The written recall procedure should include the following information:

• Name of the person(s) responsible for a recall procedure, e.g. recall coordinator;
• Roles and responsibilities for coordination and implementation of a recall;
• Methods to identify, locate and control recalled product;
• A requirement to investigate other products that may be affected by the hazard and that should be included in the recall;
• Procedure for monitoring the appropriate level of distribution specified in the recall notice; and
• Mock recall procedure, if applicable.

7.1 Product code identification

Recommended type of documentation: Protocols, procedures, or SOPs, and records.

Manufacturers must demonstrate that:

• Each prepackaged food has permanent, legible code marks, or lot numbers on the packages;
  • The code identifies the establishment, and the day, month, and year in which the food was produced;
  • The code marks used and the exact meaning of the code are available;
  • Where a case is used, the case codes are legible and represent the code on the container within the case;
• The product code and lot number identification system must include;
  • Incoming raw materials and food contact packaging materials;
  • Rework or returned materials, if applicable;
  • In-process and carryover materials, if applicable;
  • Finished products;
• Periodic testing is implemented to;
  • Verify the capability of the procedure to rapidly identify and control a code lot of potentially affected product;
  • Reconcile the amount of product produced in inventory and distribution; and
  • Identify and correct any deficiencies in the recall procedure.

7.2 Records

Records should be submitted to show that the recall program is designed and maintained to facilitate the location of the product in the event of a recall.

The following minimum information is required for distribution records:

• Product identification and size, lot number or code and quantity;
• Customer names, addresses and phone numbers for the initial level of product distribution; and
• Final reports from mock or actual recalls are prepared at the completion of a recall, which should include final results of traceability, recovery and disposal of recalled product, related investigations and corrective actions, and communications with regulatory authorities.

8.0 Documentation and records

This section should be read in conjunction with Sections 3.4, 3.17 and 3.18 of the GMPs where the requirements for documentation and records are outlined.

Manufacturers are required to:

• Keep appropriate records of processing, production and distribution;
  • Establish documentation and records of all procedures related to the GMPs, such as;
  • All incoming materials;
  • Monitoring of critical control points, e.g. records outlining effective thermal processing temperature;
  • Cleaning and sanitation;
  • Microbiological verification specifications of finished products; and
  • Environmental monitoring.

Manufacturers must demonstrate that:

• Records are legible, permanent, and accurately reflect the actual event, condition or activity;
• Errors or changes are identified in a manner such that the original record is clear, such as strike out with a single stroke and initialing the correction or change;
• Each entry on a record is made by the responsible person at the time that the specific event occurred;
  • The completed records are signed and dated by the responsible person;
• Critical records (e.g. the records related to thermal treatment) are signed and dated by a qualified individual designated by management prior to the distribution of the product;
• All other records are reviewed at an appropriate frequency to provide early indication of potential serious deficiencies;
• Detailed distribution records are maintained, for a minimum period of one year after the product's expiry date, or as per the requirements in the SFCR, i.e.;
  • Two (2) years after the day on which the record is made;
  • Three (3) years for low acid canned food processing records; and
• All required manufacturing and quality control records, results of all analyses carried out, distribution records and customer complaints for each lot of infant formula for a minimum of one year after the product's expiry date or longer if specified in the SFCR are maintained or are accessible, in Canada.

9.0 Process validation, qualification and control

This section should be read in conjunction with Sections 3.4, 3.17 and 3.18 of the GMPs where the requirements for documentation and records are outlined.

Process validation, qualification and control are required to demonstrate that manufacturer consistently manufactures infant formulas and human milk fortifiers meeting all safety and quality requirements at all times, including:

• Application of programs described in Section 2 to Section 8 of this document;
• Applicable technical and equipment standards that are specified in Sections 1.0, Section 3.9 (Subsection 1 – 4), and Section 3.5 as well as Appendix 1 of the GMPs; and
• Codex Guidelines for the Validation of Food Safety Control Measures, CAC/GL 69 – 2008 (last updated in 2013).

In addition, manufacturers are required to have information on how they design, implement, monitor and review effective control systems for powdered and liquid infant formulas, as well as human milk fortifiers, including frozen human milk fortifiers.

By submitting appropriate documentation, manufacturers must demonstrate that:

• There is an approved written validation protocol for manufacturing processes describing the objectives, processing conditions, and key variables for the study;
• Prior to the first commercial release of any new infant formula or human milk fortifier, process qualification studies are planned, conducted by technically qualified persons and properly documented;
• Validation batches to be released for sale meet all quality, stability and regulatory requirements;
• Concurrent validation studies are conducted where applicable;
• Defined processing procedures and instructions, using the specified ingredients, materials, and equipment, consistently yield a product that meets the required specifications (may require several batches);
• All observations, data, and conclusions reached are summarized in a formal validation report which is reviewed and approved by technically qualified personnel, according to Appendix 1 of the GMPs;
• Process qualification and control are recorded including;
  • Product description and formulation for infant formula or human milk fortifier used in the qualification/validation studies to provide the basis for assessment and control of food additives, composition, labelling and nutritional requirements, food allergens, and the manufacturing process;
  • Product preparation (weighing, staging, blending, mixing, compounding) and time, and temperature control for intermediate storage;
  • Work sheets, calculations, ingredient inventory balance sheets, and finished product testing to verify effective control of ingredients and additives;
  • Certificates of analysis of all raw ingredients and the description of packaging material if available from ingredient and packaging suppliers as per Section 3.8 of the GMPs;
  • Process flow diagram including controls, such as the key heat treatment step or thermal processing (including processing time and temperature), intermediate storage, steps from the heat treatment process to drying, drying (including filtering of air intake), cooling, dry blending, finished product storage, filling and packaging (container closure/container integrity;
  • Control of microbiological and allergen cross-contamination, physical and chemical contaminations according to all relevant sections of this document, as well as Section 1.0 and Section 3.5 of the GMPs;
  • All processing systems, including retort and aseptic processing systems, are validated/qualified by a process engineer/equipment manufacturer or a process authority, where appropriate;
  • All critical control points identified in the processing of infant formula or human milk fortifier, such as commercial sterilization (liquids) or pasteurization (frozen or powdered human milk fortifier or powdered infant formula), are validated and verified;
  • All identified hazards and the ability of the food control systems to control them are considered;
    • Where monitoring is required, there are records on the monitoring procedures, corrective actions that are taken when deviations occur, including all verification activities according to Appendix 1 of the GMPs;
  • Cleaning and sanitation, including validation of the CIP system, as well as any records of results of monitoring, verification by audit, or microbiological sampling;
    • Revision and adaptation of cleaning and sanitation to reflect changes in circumstances according to Section 3.5 in the GMPs; and
  • Training records of personnel involved in qualification studies.

10.0 Additional information relevant to the control of infant formula and human milk fortifier products

Documents, protocols, standard operating procedures (SOPs) or records should be submitted on the control of relevant aspects of infant formula and human milk fortifier products.

Manufacturers must demonstrate that:

• There is a written protocol for effective control of approval, distribution, and revision of all critical documents and data as indicated in Section 3.4 of the GMPs;
• There is written documentation to show that the manufacturer has a Quality Assurance, Quality Control (QA/QC), and laboratory operations, as required by the Section 3.6 of the GMPs;
  • The QA/QC department is under the direction of a technically qualified person who reports directly to a unit other than production;
• There is a written program/protocol/procedure for end product/finished product testing according to Section 3.10 of the GMPs;
• There is a written protocol for selection, approval and control (or audit) of third party production and packaging establishments, according to Section 3.11 of the GMPs;
• There is a written protocol to ensure that imported product is produced under Quality and GMP standards, according to Section 3.11 of the GMPs;
• There is a written protocol or a stability program established and maintained, which specifies the stability sample requirements, test schedule, and required physical, chemical and microbiological test requirements for each product or product family, according to Section 3.13 of the GMPs;
• There is a written protocol for documenting problems, according to Section 3.14 of the GMPs;
• There is a written protocol for recording, investigating, and reporting customer complaints, according to Section 3.15 in the GMPs; and
• There is a written protocol for carrying out internal quality audits or self-inspection, according to Section 3.16 of the GMPs.