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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

GMP, GLP, GCP and QMS Audit and Audit Remediation. Vendors, Suppliers, and FDA Mock Audits

  • 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

GMP Publications, CFR Mini Handbooks, FDA, European, International GMP, GLP, GCP and QMS
GMP, GLP, GCP and QMS Audit and Audit Remediation. Vendors, Suppliers, and FDA Mock Audits
GMP Boot Camps, GMP, QMS Training Webinar and On-site GMP Training
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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