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Audit, Investigations and Gap Analysis

GMP, GLP, GCP, US FDA,EU EMA, ISO, Audits supporting:​

  • Pharmaceuticals - Development and Manufacturing

  • APIs, Excipients and Controlled Substance

  • Medical Device - Engineering to Manufacturing

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  • Mock FDA, PAI, Due-diligence, 'For-Cause'

  • Vendors and Supplier Qualifications

  • Contractors (CMO, CPO, CAO, CRO)

  • 21 CFR Part 820 Assessments

  • MDR 2017/745 & 746, ISO 13485

  • Dietary Supplements and Nutraceuticals

  • Cosmetics

  • Biologics, Blood, Cell and Tissue

  • Outsourced Compounding Facilities 503B

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Full-Service Turn-key Auditing Service:
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With over 35 years in the industry, The Auditing Group has the experience to ensure your Company's success!

 

Are you ready for a site inspection?

The GMP Engineering staff at The Auditing Group provide you hands-on, on-site expertise to prepare you, your staff and more importantly, your facility for an on-site Agency inspection, ensuring your Commissioning and Qualification of your site is ready for inspection!

With over 35 years of Design/Build GMP Audit experience, our Engineering staff provides the expertise, and tools required to pass an on-site inspection and facility preparation. Provide on-site inspections of your facility;

  • Design/Build GMP Project and Construction Management;

  • As-build drawing qualifications, Architectural, Mechanicals/HVAC, P&ID, Plumbing/Piping, Electrical;

  • Fire Protection, Environmental, Safety and Health;

  • Security Systems (DEA Assessments);

  • ISO 8 through 5 Engineering Analysis;

  • Development of Validation Master Plans and Validation Protocols;

  • Balancing Load Calculations and HVAC Qualifications;

  • New Facility GMP GAP Analysis and Inspections;

  • Aseptic Operations;

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