Auditing

Auditing provides manufactures with critical information to access risk control, improve core competencies, and as a future planning tactical tool.

At ARS, our auditing services range from simple verification of regulatory compliance to a determination of the quality, efficiency, and effectiveness of manufacturing processeses.

ARS has extensive experience with GMP compliance for all six (6) quality systems: quality management, facilities and equipment, materials, production, packaging and labeling, and laboratory controls.

ARS provides auditing service for GMP compliance in the following areas:

  • Dietary supplements according to 21 CFR 111 and/or USP general chapter <2750>
  • Foods according to 21 CFR 117 and/or draft USP general chapter <2740>
  • Drug products and active pharmaceutical ingredients (APIs) according to 21 CFR 210/211 and ICH Q7;
  • Pharmaceutical excipients according to ANSI 363 and USP general chapter <1078>
  • Cosmetics according to ISO 22716:2007
  • Good agricultural and collection practice audits according to the AHPA-AHP guideline

Audit Types (both in person or virtual):

  • Supplier qualification audits (ingredient manufacturers and laboratory services)
  • Third-party certification audits (USP Verification Program)
  • GAP audits
  • Mock USP verification audits or regulatory audits
  • Desk audits (Good Documentation Guidelines)

At ARS our reports include a narrative of the audit performed and a listing of all nonconformities found. For GAP audit and mock audits, audit reports also include corrective action and preventive action recommendations for each nonconformity found.

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