GMP Compliance for Dietary Supplements
The U.S. Food and Drug Administration issued the final rule establishing regulations to require current good manufacturing practices (CGMPs) for dietary supplements.
The current good manufacturing practices (CGMPs) final rule will require that proper controls are in place for dietary supplements so that they are processed in a consistent manner, and meet quality standards.
The CGMPs apply to all domestic and foreign companies that manufacture, package, label or hold dietary supplements, including those involved with the activities of testing, quality control, packaging and labeling, and distributing them in the U.S.
The rule establishes CGMPs for industry-wide use that are necessary to require that dietary supplements are manufactured consistently as to identity, purity, strength, and composition.
The requirements include provisions related to:
the design and construction of physical plants that facilitate maintenance,
cleaning, proper manufacturing operations, quality control procedures,
testing final product or incoming and inprocess materials, handling consumer complaints, and maintaining records.
Dietary Supplement manufacturing sites have been increasingly inspected by the FDA for compliance with the GMPs, and warning letters have been issued. In the face of the increasing scrutiny by the FDA, it is incumbent on dietary supplement manufacturers to understand the regulations and to implement documentation and procedures that will ensure compliance.
Why should you attend: The regulations require that you understand the requirements and establish a Quality System designed to meet them. This presentation will review the requirements and the rationale for them.
Areas Covered in the Session:
Who Will Benefit:
- History of the regulations and their current status
- Review of the key points of the regulations
- Discussion of methods that can be used to comply with the regulations
- Documentation that is required for compliance
- The role of the Quality organization
- What to expect during an FDA inspection
- How to respond to an FDA inspection
- Raw material control and incoming inspection
- Cleaning and Maintenance
- Senior Management
- Quality Control Management and personnel
- Manufacturing management and supervisors
- Warehouse Management and supervisors
- Shipping and Distribution Management and supervisors