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.