CGMP 21 CFR Part 111 Audit Checklist for Dietary Supplement Manufacturers

Dietary supplements have become an increasingly popular means for maintaining health, losing weight, and improving performance. Compliance with FDA regulations can be challenging; automating quality processes can provide relief.

Supplement manufacturers can utilize USP’s audit checklists for 21 CFR part 111 CGMP compliance evaluation to help gauge their levels of compliance. Available both as Adobe Acrobat PDF files and Microsoft Word versions, these audit checklists can assist them in measuring their levels of adherence.

Checklist for Good Manufacturing Practices (GMPs)
Dietary supplements have grown increasingly popular with consumers who expect them to be safe and effective, which is why the CGMP 21 CFR Part 111 rule for manufacturers of dietary supplements requires them to comply with good manufacturing practices.

Your company must establish and implement a system to track product development, production, testing and packaging processes – this may include quality control measures as well as production records and delivery evaluations. Furthermore, an investigation procedure must also be in place so any consumer complaints can be managed properly and handled.

Facility must possess sufficient trained personnel and appropriate equipment in order to fulfill its responsibilities effectively. Quality systems should be well documented and well maintained. Computerized systems should have proper controls in place to prevent unauthorized access while also having backup systems so data does not get lost during malfunctions. A written procedure must exist for qualifying critical equipment and auxiliary systems while process validation results should be recorded and documented accordingly.

Checklist for Good Distribution Practices (GDPs)
EAS offers quality management system implementation and compliance audit services for 21 CFR Part 111 regulations, auditing your facility to meet these regulations on both an on-site or contract manufacturing basis. Our team of former FDA investigators and industry quality experts is ready to audit your manufacturing, packaging, distribution and laboratory facilities; gap analyses; mock FDA inspections are also provided as training opportunities or to assess compliance levels ahead of actual FDA visits.

Checklist for Good Packaging Practices (GPPs)
GMP Audit Checklist for Dietary Supplement Manufacturers that Produce Packaging with Indirect Food Contact: A Comparison (by Manufacturers of Direct Contact with Foods). The checklist should focus on risks identified as relevant to this type of business and address them as quickly and thoroughly as possible.

Line clearance procedures must ensure that only appropriate material is stocked in each line and any out-of-specification products can be quarantined and evaluated to assess if they are safe, acceptable quality and legal.

System must also be in place to validate that printed packaging meets all necessary specifications, such as shipping marks being legible and authorized correctly, dimensions being accurate etc.

Checklist for Good Labeling Practices (GLPs)
GLPs, set forth by the FDA, provide standards and regulations for nonclinical laboratory tests and studies designed to ensure human experimentation only takes place when absolutely necessary. They also outline regulations regarding clinical trials, which provide a framework for how they should be run as well as evaluation and reporting procedures for any results obtained during trials.

An FDA 21 CFR Part 111 compliance checklist is an invaluable way of evaluating whether or not your company meets all FDA regulations regarding dietary supplements. The checklist comes in PDF and Microsoft Word formats for easy customization to meet specific company needs.