What is cGMP?

This is current Good Manufacturing Practice (cGMP). EAGLE offers cGMP audits for dietary supplements.

Good Manufacturing Practice (GMP) audit vs. cGMP audit

A GMP audit and a cGMP audit are related but slightly different in terms of scope and focus.

A GMP audit is conducted to assess whether a manufacturing facility, process, or system meets requirements and regulations for good manufacturing practices. GMP requirements ensure that products are consistently produced and controlled to meet quality and food safety standards appropriate for their intended use. GMP audits typically cover a wide range of areas, including facility design, equipment qualification, personnel training, documentation, quality control, and product testing.

A cGMP audit is where the “current” aspect signifies that the audit evaluates compliance with the most up-to-date GMP standards at the time of the audit. cGMP audits are more focused on dietary supplements which are regulated in the U.S. by the Food and Drug Administration (FDA). The purpose of a cGMP audit is to ensure that dietary supplement manufacturers adhere to the current GMP requirements related to production, testing, and distribution.

The Dietary Supplement (DS) CGMP rule in 21 CFR part 111 (“the DS CGMP rule”) requires persons who manufacture, package, label, or hold a dietary supplement to establish and follow current good manufacturing practice to ensure the quality of the dietary supplement and to ensure that the dietary supplement is packaged and labeled as specified in the master manufacturing record.

 Benefits of a cGMP audit with EAGLE

 EAGLE can provide assurance for:

• Quality Control: Implementing systems to ensure that the dietary supplement is manufactured, packaged, labeled, and held in a manner that ensures quality, purity, strength, and composition.
• Facility and Equipment: Establishing and maintaining a suitable facility and equipment to manufacture and handle dietary supplements, including appropriate sanitation practices and controls.
• Personnel: Training and qualification of personnel involved in manufacturing, packaging, labeling, and holding of dietary supplements to ensure their competence and understanding of cGMP requirements.
• Raw Materials: Specifications are established for the identity, purity, strength, and composition of each component used in the manufacturing process, including dietary ingredients and other additives.
• Manufacturing Operations: Implementing controls and procedures for the manufacturing process, including formulation, mixing, and blending, to ensure consistency, accuracy, and appropriate control over the process.
• Packaging and Labeling: Packaging and labeling of dietary supplements are accurate, informative, and comply with applicable regulations.
• Record Keeping: Maintaining complete and accurate records of all aspects of the manufacturing, packaging, labeling, and holding of dietary supplements, including batch records, test results, and distribution records.
• Complaint Handling: Procedures for handling and investigating consumer complaints related to dietary supplements to identify and address potential quality issues.
• Adverse Event Reporting: Systems are in place to capture and report any adverse events associated with the use of dietary supplements to regulatory authorities as required.

If you are a dietary supplement manufacturer looking to be an industry leader and wanting to demonstrate to your customers and consumers that you care, then talk to EAGLE about our cGMP audit!