Description
cGMP stands for current Good Manufacturing Practices. In the USA, for food manufacturing, these are prescribed by the Code of Federal regulations, 21 CFR Part 117. Prior to this the GMPs were published in 21 CFR Part 110, which was replaced making way for Part 117.
This GMP: Food Manufacturing for Professionals (21 CFR Part 117) program includes three (3) individual courses. The first course, GMP Awareness: Food Manufacturing, focuses on providing an understanding and appreciation of cGMP (current Good Manufacturing Practices) and its significance in the food industry. However, before getting into GMP, the Food Safety Modernization Act (FSMA) is described, which was signed into law in 2011. FSMA is the most significant change in food safety law since the passing of the Food, Drug, and Cosmetic Act in 1938. The course moves on to provide a brief history of cGMP for the US food industry. Here we explore the origins and development of cGMP in the context of the food industry.
The six (6) key reasons why following cGMP guidelines is crucial in ensuring food quality and safety are introduced. Then, we move onto introducing the nine (9) principles which assist in implementing cGMP in any food manufacturing company. An assessment is provided to understand learning outcomes and is designed to evaluate the learners’ understanding and knowledge acquired during the training.
The second course, GMP: Food Manufacturing Warning Letters and Case Studies, describes what happens when the FDA discovers significant violations of its regulations by a manufacturer and initiates communication with the manufacturer through a Warning Letter. This letter points out the specific violation. The FDA emphasizes that the company must rectify the problem and provides instructions for responding with its corrective plans. The FDA then verifies the adequacy of the company’s corrections. In this course, GMP: Food Manufacturing Warning Letters and Case Studies, several case studies which resulted in the issuance of Warning Letters are discussed.
Overall, the FDA’s audits serve as an opportunity for food facilities to identify areas of improvement and enhance their commitment to food safety and quality. Addressing GMP violations promptly and implementing robust corrective actions are critical for maintaining compliance and protecting public health. This course uses case studies to describe why Warning Letters may be issued and how they must be handled, especially with respect to addressing the concerns or issues with appropriate corrective actions.
The third course in this program, GMP for Food Manufacturing: The Nine (9) Principles (21 CFR Part 117), describes the nine (9) principles which help implement cGMP in any Food Industry, as per the guidelines prescribed in 21 CFR Part 117 Subpart B – current Good Manufacturing Practice. In this course, GMP for Food Manufacturing: The Nine (9) Principles (21 CFR Part 117), these 9 principles are described:
- 1. Personnel (21 CFR Part 117.10)
- 2. Plant and Grounds (21 CFR Part 117.20)
- 3. Sanitary Operations (21 CFR Part 117.35)
- 4. Sanitary Facilities and Controls (21 CFR Part 117.37)
- 5. Equipment and Utensils (21 CFR Part 117.40)
- 6. Processes and Controls (21 CFR Part 117.80)
- 7. Warehousing and Distribution (21 CFR Part 117.93)
- 8. Human Food by-products as Animal Feed: Holding and Distribution (21 CFR Part 117.95)
- 9. Defect Action Levels (21 CFR Part 117.110)
Once the 9 principles have been introduced and described, the program moves on to describe the implementation of cGMP requirements in the facilities. This section notes that food manufacturers must develop a written plan that includes hazard analysis and risk-based preventive controls. They must also establish monitoring procedures, corrective actions, verification procedures, and record-keeping systems.
Once this program is complete, students will understand that cGMP is a set of principles and procedures that must be followed to ensure that the products manufactured in the Food Industry are manufactured to the required quality and safety standards. Students will be exposed to the evolution of GMP for the Food Industry and learn its importance through case studies describing times when Warning Letters have been issued to companies for non-compliance. Students will understand the importance of FDA inspections in ensuring that the industry complies with cGMP regulations. Students will be exposed to the 9 main principles for cGMP implementation as per 21 CFR Part 117 in the Food Industry. Students will go through details of the guidance on: Personnel, Plant and grounds, Sanitary operations, Sanitary facilities and controls, Equipment and utensils, Processes and controls, Warehousing, and distribution, Holding and distribution of human food by-products for use as animal food, and Defect action levels.
