Good Manufacturing Practices are guidelines that provide a system of processes, procedures, and documentation to assure the product produced has the identity, strength, composition, quality, and purity that it is represented to possess. This course is an introduction to the principles and practices of Good Manufacturing Practices (GMP). Emphasis is on topics of common interest to all those involved with GMP-governed products, regardless of product type.
After completion of Good Manufacturing Practices (GMP), students will be equipped with a basic understanding of the following:
- How to apply the principles and practice of GMP
- How to be conversant in all core elements of GMP as practiced in a real world workplace setting
No prior experience or coursework required.
Students will be assigned 5 homework assignments, and 1 final exam.
Module 1: Premises
- Design, construction, and maintenance of the production and staff areas in the facility.
- Layout (design) of the facility.
Module 2: Equipment
- Design, construction, and maintenance of equipment.
- Equipment arrangement and operation.
- A cleaning-in-place process.
Module 3: Personnel
Ensuring facility personnel are qualified for their job responsibilities.
Module 4: Sanitation
- Sanitation programs: sanitary manufacture, packaging/labeling, including: documented cleaning procedures for premises and equipment
- Employee health and hygiene.
- Documenting health requirements and following health-related procedures.
- Establishing a hygiene program for the facility.
Module 5: Raw Material Testing
- Testing raw materials.
- Identifying when product or raw materials must be tested.
- Accepting raw materials from a vendor without additional regular testing.
- Supplier certification
Module 6: Good practices in production & control
- Controlling the manufacturing process.
- Stages in the production cycle.
- Self-inspection programs for fabricators, packagers/labelers, distributors.
Module 7: Quality Control Department & Audits
- Establishing a QC department.
- Investigating product quality.
Module 8: Packaging Material Testing
Testing requirements for packaging materials including supplier certification.
Module 9: Finished Product Testing
- Finished product testing.
- Writing product specifications.
- Conditions and options for finished product testing.
Module 10: Records
- Maintaining accurate, clear, and precise documents.
- Identifying individuals responsible for maintaining documents.
This course is Instructor-led and delivered through our award-winning online Learning Management System.