Description
There are a total of nine (9) principles which help implement cGMP in any food manufacturing company, 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 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.
