Dietary Supplement Manufacturer Audit Preparation - NPI

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"Common Mistakes Auditors Find

Recent GMP audits reveal companies failure to perform tasks in two main areas:

Quality Issues

• Perform required identity testing on incoming dietary ingredients raw materials
• Set appropriate specifications for raw materials, components and finished good product
• Perform finished good product testing confirming identity, strength and composition
• Lack of finished product release criteria (does finished batch conform to product spec?)
• Adopt written procedures (e.g., SOPs)
• Prepare and follow master manufacturing records (MMR) and/or batch production records (BPRs) for manufacture of dietary supplements (with formulation and batch size)
• Document corrective actions undertaken
• To conduct required material reviews and make disposition decisions

Facility Issues

• Physical plant design
• Sanitation requirements of the physical plant and associated grounds
• Issues with manufacturing equipment and utensils"

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