Auditing

Trusted Expertise for Ensuring Compliance

Achieve Compliance with Quality Auditing Services from cGMP Consulting

Our expert quality auditors provide invaluable industry insights that are often difficult to replicate in-house. We know many organizations struggle to find the time and resources for thorough internal audits. Plus, managing corrective actions can pull your team away from crucial, profit-generating projects and daily operations. Let us take that burden off your shoulders–so your team can focus on what they do best while we ensure your compliance needs are met.

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Pharmaceutical Inspections and Compliance

AUDITING

At cGMP Consulting, our audits are a key element of an effective Quality Management System.

We follow a systematic, structured approach to evaluate your organization’s adherence to relevant standards, regulations, and best practices. Our audit process includes:

  • Identifying areas of non-compliance
  • Assessing potential risks
  • Recommending corrective actions

Benefits of Our Audits:

  • Determine your current level of adherence to GMP or other guidelines
  • Pinpoint areas for improvement
  • Strengthen your Quality Management System to ensure it remains robust and compliant

Audit Process

Overview:

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1

Planning and Preparation

We define audit objectives aligned with organizational goals, determine the scope, and gather documentation like SOPs and previous findings. We notify relevant departments and set an audit agenda.

2

On-site Audit Execution

We begin with a meeting to outline goals, conduct site tours and personnel interviews, and review documentation, concluding with a meeting to discuss initial findings.

3

Reporting and Remediation

We document findings, highlight areas of non-compliance, and share a report with prioritized, actionable areas for improvement. We are also fully qualified to issue GMP Certificates.

Industries Served

Biologics / BiotechnologyCosmeticsDietary SupplementsDistributorsFoodGene TherapyMedical DevicePharmaceuticalsRadiopharmaceuticals

Biologics/Biotechnology
Cosmetics
Dietary Supplements

Distributors
Food
Gene Therapy

Medical Device
Pharmaceuticals
Radiopharmaceuticals

Auditing Services

Each service is designed with your success in mind

Internal Audits

Internal Audits

Our internal audits ensure a robust Quality Management System by identifying gaps and fostering continuous improvement within your organization.

External Audits

Product Listing

External audits conducted by cGMP Consulting assess compliance with regulatory standards, enhancing product safety and public trust.

Pre-Approval Inspection Readiness

Pre-Approval Inspection Readiness

Our Pre-Approval Inspection (PAI) Readiness Audits prepare your site for regulatory inspections by simulating conditions and identifying potential compliance issues.

Supplier Audits

Supplier Audits

Our supplier audits evaluate and monitor suppliers to ensure ongoing GMP compliance, protecting product integrity and quality.

Contract Manufacturer Audit

Contract Manufacturer Audit

Our contract manufacturer audits assess compliance with quality standards and regulatory requirements to safeguard your brand.

GMP Certification Audits

GMP Certification Audits

Our GMP certificates show adherence to high industry standards, enhancing market access and consumer confidence.

GMP Gap Assessments

GMP Gap Assessments

Our GMP gap assessments identify discrepancies in practices, aiding companies in transitioning to full compliance with GMP standards.

Due Diligence Assessments

Due Diligence Assessments

cGMP Consulting identifies regulatory risks and compliance gaps, helping you make informed decisions and improve your regulatory standing.

Other Audit Support Services

Each service is designed with your success in mind

Audit Readiness Training

Audit Readiness Training

cGMP Consulting offers tailored audit readiness training to equip your team with the knowledge and skills needed to confidently prepare for regulatory inspections and customer audits.

Audit Remediation

GMP Gap Assessments

cGMP Consulting collaborates with your team to effectively address and resolve findings from past audits, ensuring compliance through comprehensive corrective and preventive action plans.

Why Choose Our Auditing Services

Achieve global compliance and operational excellence with our quality auditing services.

When it comes to ensuring regulatory compliance and operational efficiency, our auditing services offer a unique combination of industry expertise, global reach, and customized solutions, delivering long-term value to your organization.

Here’s how we stand out:

1

Expertise & Experience

Our team consists of seasoned industry professionals with extensive knowledge in cGMP compliance and auditing. Since 2001, we’ve been guiding clients through complex regulatory issues with precision.

2

Global Reach

Our quality auditors have traveled the globe for our clients, ensuring that your business meets international compliance regulations and standards no matter where or what industry you operate.

3

Tailored Solutions

We understand that every organization is unique. Our auditing services are tailored to your specific business needs and challenges, ensuring aligned solutions to your operational goals.

4

Proven Track Record

With a long history of helping companies to achieve and maintain cGMP compliance, we not only help you meet regulatory requirements but also enhance your operational efficiency.

5

Comprehensive Approach

From initial assessments to ongoing training and support, we provide a holistic, end-to-end approach to cGMP compliance, positioning your organization for sustained success.

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