Rwanda FDA GMP Guidelines for Food Products

What does the acronym GMP stand for?

What are the four types of GMP inspections?

What is the main purpose of these guidelines?

The GMP inspection should be conducted by physically visiting the manufacturing site.

The location of a food manufacturing facility should be at least 100 meters away from residential areas.

What are the three categories for new applications?

The GMP inspection should be conducted using one of the following methods: Physical inspection, Virtual inspection, Desk review.

The quality and hygiene of food manufacturing premises should be controlled to minimize contamination and the building up of dirt and condensate.

What are the three types of water used in food manufacturing facilities?

What is the role of the food safety management system?

What are the three basic categories of non-compliances that are used to determine regulatory actions?

A critical non-compliance is a failure of the management system that could result in the highest risk of producing a product that is unsafe, fraudulent, or does not meet legal requirements.

What is the purpose of the HACCP plan?

The HACCP plan shall cover CCP, significant Hazard, Control Measures, Monitoring Requirements, Monitoring Frequency, Critical Limits, Corrections/Corrective Action, Responsibility, Records.

A manufacturer who contravenes the provisions of this regulation commits an administrative offence and upon conviction shall be liable to the penalties prescribed in Authority regulations related to regulatory service tariff/fee and fines in force.

The Authority may establish a scientific and advisory committee comprising of internal and/or external experts from different fields and scientific research to advise the Authority on Good Manufacturing Practices inspection matters.

This regulation shall enter into force upon their approval and publication on the Authority's website

Upon fulfilling the requirements, the Authority shall issue a Certificate of good manufacturing practice. The certificate shall be valid for a period of 3 years.

A food safety prerequisites manual, or FSPM, should include details on production, sanitation, and hygiene.

The FSPM should include a list of contract manufacturers and laboratories, including addresses and contact information, and flowcharts of the supply chains for these outsourced activities.

The quality manual should begin with an introduction containing a brief overview of the quality manual and laboratory, outlining the lab's history, activities, and updating processes.

The quality policy section of the quality manual should address the management commitment to quality and outline the mission, objectives, and roles that guide all laboratory activities.

The quality manual should include job descriptions, a personnel list, and an organizational chart outlining the recruitment process for all personnel.

The quality manual should include a description on the facilities and environmental requirements for the laboratory.

Defining procedures and practices to maintain a safe environment within the laboratory should be a priority for all staff members.

The quality manual should contain a statement regarding the commitment of the laboratory and reference the link with other control procedures.

The GMP Inspection Checklist is a document used to ensure that all the requirements for Good Manufacturing Practices are met by a facility.

When conducting a GMP inspection, the interviewer should assess the following: premises and equipment, utilities and air, personnel, documentation, good practices in quality control, customer complaint handling, traceability system, emergency preparedness and response, self-inspection, and change control.

The GMP Inspection Checklist is a comprehensive document designed to provide a thorough assessment of a food manufacturing facility's compliance with Good Manufacturing Practices (GMP) requirements.

What is the acronym for Rwanda Food and Drugs Authority?

What is the name of the document outlining the Good Manufacturing Practices (GMP) for food products?

Which of the following are included in the areas of GMP inspection? (Select all that apply)

The layout of premises and the flow of operations, including the movements of personnel and material within the buildings, shall be such that cross-contamination is maximized or prevented.

Food manufacturing premises shall be located in the ______ area.

What is the minimum distance food manufacturing premises should be located away from a residential area?

Match the following types of GMP inspections with their descriptions: