Rwanda FDA GMP Guidelines

Rwanda FDA Guidelines for Good Manufacturing Practices (GMP)

• Issued in January 2023
• Document number FDISM/FDIC/GDL/004
• Revision date was January 23, 2023
• Review was due in January 30, 2026
• Effective date January 31, 2023

Foreword

• Rwanda Food and Drugs Authority (Rwanda FDA) established by Law N° 003/2018 of 09/02/2018 is a regulatory body
• One of main powers is to formulate regulations/guidelines for food product manufacture, ensuring compliance with quality standards for good manufacturing practices
• Food product manufacture should embrace clearly defined principles, feature specialized functions and vigilance by qualified personnel
• Quality of a product is a summation of intangible factors that ensure sufficient performance of desired functions
• Quality should be built into every phase of manufacturing and production
• Excellence reflects the integrity, competence, and pride of all involved in the design, production, and marketing
• Good Manufacturing Practices (GMP) have a major impact on the food industry
• These guidelines describe the minimum requirements that Rwanda FDA considers necessary for food production for human consumption
• The guidelines address requirements for manufacturing premises, equipment, personnel, and process controls
• Documentation, storage, validations, and manufacturing processes encompassing packaging and labelling are also covered
• These guidelines are general guides and shall be adopted for individuals needs
• The guidelines justify GMP status for manufacturing authorization of local facilities
• It is a prerequisite before registration of food products

Guidelines Development History

• Draft Zero - May 2019
• Adoption by Rwanda FDA - May 13, 2019
• Stakeholders Consultation - August 25, 2022
• Adoption of Stakeholders comments - September 2, 2022
• Date for coming into effect - January 31, 2023

Document Revision History

• May 2019, Revision 0 (First Issue)
• January 23, 2023, Revision 1
• Scope and policy were added
• Chapters 1, 2, and 3 content were added
• The following annexes were added:
  • Application for Good Manufacturing Practice inspection for food product manufacturing facilities
  • Requirements for GMP application for food manufacturing facilities
  • Good Manufacturing Practices (GMP) inspection checklist
  • Content of site master file
  • Format of Corrective and Preventive Action (CAPA)
  • Content of Quality manual
  • Format of the inspection report
  • Certificate of compliance with good manufacturing practice

Acronyms and Abbreviations

• GMP: Good Manufacturing Practices
• QA: Quality Assurance
• QC: Quality Control
• SOP: Standard Operating Procedures
• CAPA: Corrective Actions and/or Preventive Actions
• ISO: International Organization for Standardization
• BRC: British Retail Consortium
• FSSC: Food safety system certification scheme
• HACCP: Hazard Analysis Critical Control Point

Glossary / Definitions

• Authority: Rwanda Food and Drugs Authority (Rwanda FDA)
• Batch: Quantity of material produced during a defined period of manufacture
• Batch Number: Unique identifier for a batch to trace its history
• Competent authority: Person/organization legally authorized to perform a food control regulatory function
• Contract manufacture: Manufacture ordered by one organization (Contract Giver) and carried out by another (Contract Acceptor)
• Critical Control Point (CCP): A material, location, practice, procedure, or process stage where loss of control results in unacceptable food safety risk.
• CIP: Cleaning In Place
• COP: Cleaning Out of Place
• Contamination: Making or being made impure via polluting or poisoning
• Documentation: Written procedures, instructions, records, quality control procedures, and recorded test results
• Durable construction: Resistance to degradation of products, materials, buildings, and other built assets over time
• Finished Product: Product that has completed all stages of manufacture and packaging
• Food Allergen: Substance causing immune response in sensitive individuals, releasing histamine
• Food Control: Mandatory regulatory activity to protect consumers. It ensures food safety, wholesomeness, and accurate labelling
• Frozen Foods: Foods preserved by freezing and storing at low temperatures
• Good Manufacturing Practice: Combination of manufacturing/quality control ensuring consistent product specifications
• Hazard Analysis Critical Control Point (HACCP): System to identify, evaluate, and control food safety hazards
• Hazard: Biological, chemical, or physical agent in food with potential adverse health effect
• Hazard Analysis: Process of collecting/evaluating hazards information to decide if they require HACCP plan attention
• Ingredients: All materials, including starting materials, processing aids, additives, and compounded foods included in product formulation
• Manufacture: A complete cycle of production from material acquisition through processing, packaging, storage and dispatch
• Packaging material: Any container or material used in packaging a product
• Processing: Transformation of raw ingredients into food, or of food into other forms
• Quality Assurance: Organized arrangements to ensure finished products meet intended use quality
• Quality Control: GMP element ensuring raw materials and finished products are not released without satisfactory quality
• Quality Management: Comprehensively designed and correctly implemented system of Quality Assurance (QA) incorporating Good Manufacturing Practices (GMP) and Quality Control (QC)
• Quarantine: Setting aside materials or product while awaiting a decision on its suitability
• Raw Material: Material, ingredient, starting material, semi-prepared/intermediate material, packaging used for production
• Rework: Unincorporated food product kept for subsequent use or reprocessing
• Risk: Probability of a particular adverse consequence resulting from a hazard within a stated time under stated conditions
• Specification: Document detailing material, machinery, equipment, or product requirements
• Potable water: Water that is suitable for human consumption
• Non-potable water: Water that is not suitable for human consumption
• SOP: Means Standard Operating Procedure
• Unsafe product: Products which cause or may cause damages either by its manufacture defect by having no instruction, preservation, warning message, or relevant information

Purpose of the Guidelines

• Provide guidance to food product manufacturers on complying with Good Manufacturing Practice (GMP)
• Form the basis for GMP inspection by Rwanda Food and Drugs Authority (Rwanda FDA) as requirement for food product registration in Rwanda
• Regulations No FDISM/FDIC/TRG/008 governs good manufacturing practices of food products

Scope of the Guidelines

• These guidelines/annexes are the basis for GMP inspection of all food product manufacturers
• This applies both within and outside Rwanda
• It covers products registered or subject to registration in Rwanda
• The guidelines apply regardless of size, product type/range, or manufacturing facility location
• Manufacturers proven GMP compliant receive GMP certificates per Article 23 of Regulations No FDISM/FDIC/TRG/008

Types of Inspections

• Routine GMP inspection: A full inspection of all GMP/licensing provisions
  • Indicated when the manufacturer is newly established, requests license renewal, has a non-compliance history, introduces new product lines/manufacturing methods, or has not been inspected in 3-5 years
• Concise GMP inspections: Evaluation of limited GMP aspects, suitable for manufacturers with a compliance record.
  • Focus is on selected GMP requirements as indicators + identification of significant changes since the last inspection
  • Evidence of unsatisfactory GMP performance during a concise inspection should trigger a more comprehensive inspection
• Follow-up GMP inspections: Reassessment to monitor corrective measures
  • Carried out 6 weeks to 6 months after the initial inspection, limited to specific GMP requirements
• Special GMP inspections: Spot checks due to complaints/recalls, focusing on a product, operations such as mixing, sterilization, or labelling
  • May be made to establish how a specific product is manufactured as a prerequisite for marketing approval or export certificate

GMP Inspection Application

• Interested parties should apply for GMP inspection by submitting documents
• The required documents are:
  • Filled and signed application form
  • Proof of payment of prescribed fees
  • Food safety prerequisites manual (FSPM)
  • License of premises for food product manufacturing
  • List of all products manufactured on site
  • Copy of any warning letter or regulatory action
  • Corrective action and preventive action (CAPA) related to any GMP inspection report
  • GMP inspection report from other competent authorities(if any)
  • Current certificates, such as GMP Certificate/, ISO 22000/HACCP/FSSC 22000/BRC
  • Product description with a brief description of the product
  • The validated description of the product formulation
  • Product testing results and stability study report
  • Self-inspection report
  • Quality Manual/Laboratory Manual or equivalent
  • Recent batch records
  • List of recalls or Market registered complaints in the last three years
  • Copy of the contract/agreement between manufacturer and outsourced laboratory
• The application should be categorized as new, renewed, variation, or relocation

GMP Inspection Methods

• Physical inspection: Conducted by physically visiting the site and applicant holding third party food safety certificate of compliance
• Virtual: Interactive inspections, by discretion of the Authority
  • The criteria of selection of applicants for virtual/remote interactive inspections:
    • Authority has declared force majeure on physical inspection
    • Application that met requirements in 2.2. that still need further clarification.
• Joint Inspection:The Authority may participate in the joint GMP inspection with regulatory Authorities
• Authority may conduct an assessment of the application by desk review or use any other inspection report

Documents Desk Review Criteria

• Applicant will be assessed under desk review when:
  • Holds food safety certificate such as ISO 22000/HACCP/FSSC 22000/BRC issued by accredited body, or
  • Holds a food safety certificate issued by a competent National Regulatory Body that has a Mutual recognition agreement with the Authority, or
  • Holds food safety certificate issued by competent National regulatory body from a stringent regulatory system
• If the applicant holds a food safety certificate and is not from the country where the National Regulatory Body has Mutual recognition agreement with the Authority, the decision will depend on the evaluation of the scheme used by the Regulatory Authority in the country of origin

Areas of GMP Inspection

• All manufacturers must apply a quality and food safety management system to ensure the production of safe/suitable food at all stages, from raw material reception to the final product

Good Hygiene Practices

• Manufacturers must adopt practices and measures to ensure appropriate hygienic conditions
• The goal is to reduce risks of contamination
• Manufacturers must ensure that the prerequisite programs are fully established, implemented and maintained to assist food safety hazard controls
• When establishing the prerequisite programs, manufacturer shall consider:

Location of Premises

• Food manufacturing premises be located in designated industrial areas or 100 meters away from residential area
• Food premises should not be located when there is a threat to food safety, unless hazards can be controlled by reasonable measures
• Premises should not introduce hazards from the environment that cannot be controlled
• Premises should be located away from:
  • Environmentally polluted areas and industrial activities which are reasonably likely to contaminate food
  • Areas subject to flooding, areas prone to infestations of pests, and areas where wastes cannot be removed effectively

Design and Layout of Food Manufacturing Premises

• Buildings should be of durable construction which presents no hazard to the product
• The design and layout of food premises should permit adequate maintenance and cleaning
• Premises layout and the flow of operations, including the movement of personnel and material should minimize or prevent cross-contamination
• Areas having different levels of hygiene control should be separated
• The design should include physical separation, location, traffic flow, separating in time, traffic, airflow, cleaning and disinfection between uses
• Adequately fence to keep out larger animals

Internal Structures and Fittings

• Soundly built of durable, materials are easy to maintain, clean and disinfect
• Constructed of non-toxic and inert materials
• Specific conditions for the safety and suitability of food
  • Walls, partitions, and floors shall be made of impervious materials that are easy to clean and, where necessary, disinfect
  • Walls and partitions shall have a smooth surface up to a height appropriate to the operation
  • Floors shall be made by smooth material free from cracks and joints to allow adequate drainage and cleaning
  • Ceilings and overhead fixtures shall be constructed to be shatterproof, and finished to minimize the build-up of dirt and condensation
  • Windows shall be easy to clean, be constructed to minimize the build-up of dirt and be fitted with removable and cleanable insect-proof screens
  • Doors should have smooth, non-absorbent surfaces, be easy to clean and, where necessary, disinfect
  • Work surfaces should be in sound condition, durable, and easy to clean, maintain and disinfect and be made of smooth, non-absorbent materials, and inert to the food

Utilities: Air, Water and Energy

• The provision and distribution routes for utilities to and around processing and storage areas should be designed to minimize the risk of product contamination
• Utilities' quality should be monitored to minimize product contamination risk

Air Quality Controls

• Room air supply quality shall be controlled to minimize risk from airborne microbiological contamination
  • Where there is risk of food product contamination, the protocols for air quality monitoring and control shall be established
  • Ventilation systems shall be designed and constructed such that air does not flow from contaminated or raw areas to clean areas
  • Ventilation system shall ensure control of unwanted odours which might affect the suitability of food
  • Specified air pressure differentials shall be maintained
  • Ventilation systems shall be accessible for cleaning, filter changing and maintenance
  • Compressed air, carbon dioxide, nitrogen and other gas systems used in manufacturing shall be constructed and maintained
• Gases intended for direct or incidental product contact approved for food contact use are
  • Filtered to remove dust
  • Filtered to remove oil and water
• Where oil is used, the oil should be food grade, recommend of oil free compressors

Water Quality Controls

• Adequate natural or artificial lighting will be provided so food production is performed so that it operates in a hygienic manner
• Lighting is adequate to check contaminants will not adversely impact
• Light fittings should be such that food is not contaminated by breakages of lighting elements

Energy

• Combustible Materials will not be the source of food contamination

Waste Disposal

• Materials should be collected, removed, and disposed of in a manner that prevents contamination
  • Be clearly identified and labelled for their intended purpose
  • Located in a designated area
  • Constructed of impervious material which can be readily cleaned and sanitized
  • Closed when not in immediate use
  • Be locked where the waste may pose a risk to the product
• Accumulation of waste not allowed in food-handling or storage areas
• Dedicated, labeled locked area for storage waste before final disposal is required
• Labelled materials, products or printed packaging designated as waste shall be disfigured
• Records of desctruction should be kept

Drainage

• Drains shall be designed and located so that the risk of contamination products or materials is avoided
• Drains have capacity sufficient to remove flow loads
• Drains shall not pass over processing lines
• Drainage shall not flow from a contaminated area to a clean area

Equipment

• Food contact equipment shall be designed and constructed to facilitate cleanliness and disinfection
• Surface shall not affect system
• Equipment shall be constructed of materials able to resist repeated cleaning
  • Smooth clean equipment
  • Use materials acceptable for cleaning/flushing agents
  • Framework cannot be penetrated by nuts, bolts or holes
  • Cannot have dead ends

Temperature control

• Equipment for processes able to control temperature gradient
• Equipment provides controls

Equipment cleaning

• Equipment needs documented plans to ensure cleanliness
• Programs specify what is cleaned and how

Preventative equipment

• There is a requirement for preventitive maintenance SOP's
• Maintenance should not contaminate product
• Proper lubrication is needed
• Sanitisation is needed

Management of purchased materials

• Purchasing of materials impact food safety, suppliers must adhere to requirements

Source of contamination and prevention

• Procedures will be established to reduce contamination
  • Physical contamination requirements documented
  • Harmful Chemicals will be documented
  • System needed to prevent/minimize microorganisms transfer

Food allergens management

• System of allergen management must be in place to address and control allergens
• Ensure allergens are declared and managed
• Line changing over practices documented
• Procedures to avoid/prevent cross contamination
• Workers must have allergen and awareness training

Cleaning and Sanitization

• Cleaning Program exists to establish maintain hygienic conditions and is monitored for suitability and effectiveness
• The Equipment must be maintained in condition to facilitate cleaning and/or sanitation
• Programs clearly defined and validated by food manufacturing standards
• Cleanliness is monitored and validated
• Parameters must be validated for in place systems

Pest Control

• Hygiene, Cleaning, and incoming materials have inspection and monitoring
• Programs must document target pests and plans

Facility pest control

• Holes need to be sealed
• Doors and windows should prevent pest entrances
• Food and water must be available to pests for elimination
• Materials must be used such that they can be identified and destroyed against pests
• Materials are protected from weather

Personnel hygiene and facilities

• Ensure the degree of the personal hygiene required
  • Locations of handwash
  • Sinks available
  • Employee hygiene do not open of product or storage
  • Changing facilities available

Staff facilities for hygeine

• Shall be designed to minimize cross-contamination and stored only in designated areas

Work area and clothing policy

• Shall wear appropriate clothing, clean and good condition
• Clothing mandated to ensure protection
• Clothing to standards as the intended use of garments

Health Status

• Emplpoyees must undergo prior to employment examination and yearly communicable diseases
  • medical examination included
    • Salmonella
    • Typhoid
    • Tuberculosis
    • Transmittable conditions

Disease and sickness procedures

• Sickness shall be reported so they can be moved or excluded
• The food handling material is safe and away from infectious conditions

Re-Handling

• Shall be stored to ensure product safety and traceability

Transportation

• Shall be constructed to not contaminate
• Clean as designed
• Able to separate from items that cause contamination
• Effectively maintain conditions
• Allows conditions to remain unchecked

Product information for awarenes

• Information can be presented in various methods
  • Shall be clearly labelled
  • Storage practices
  • Identifies the allergen

training and competency policy

• Shall understand competency of food safety and operations _ Personal understands contamination
• Training will be refreshed and record
  • Training programs
  • Material for training

Procedures to follow

• Food defence shall assess terrorism hazard
• The manufacturer is secured
• Hazards should be assessed for what they contain

Work Environment

• Work is proper to health
• Sound parameters will be set

Identification of Hazards (HACCP)

• Used when supplying is safe and the benefits will be supplied
• Manual will follow
  • assemble the team
  • describe product
  • Identify use
  • Confirmation on-site
• All hazards that lead to occur and be a hazard
  • Limit establishment
  • Monitor the control points

HACCP Plan that is to be implimentation

• That can lead to increase of raw material and assessments of validation

Personnel

• People must know to operate all levels and a GMP that ensure organization

Documentation

• Used by the manufacturers for what they do
• Document that covers maintenance Document can contain
• FSPM
• manual'
• Characteristics
• Validation