Wednesday, June 25, 2014

Dietary Supplement Manufacturer Audit Preparation - NPI

Read the full article: Dietary Supplement Manufacturer Audit Preparation - NPI:

"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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