GMP Certification Audits

Ensuring Quality and Compliance in Manufacturing
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The Importance of GMP Certification in FDA Regulated Industries

In many FDA-regulated industries, achieving Good Manufacturing Practice (GMP) certification is no longer just an advantage—it’s a necessity. GMP certification serves as a vital benchmark for brands and manufacturers, demonstrating regulatory compliance and establishing trust with customers and industry partners.

At cGMP Consulting, our ISO/IEC 17020:2012 accreditation allows us to provide GMP certification to qualified auditees, the requirements tailored to meet your industry’s specific regulations. By achieving this distinguished status, you demonstrate your organization’s dedication to product safety, quality assurance, and regulatory compliance—essential factors for building customer loyalty and gaining a competitive edge.

AUDITING

Understanding GMPs and Regulatory Compliance

Good Manufacturing Practices (GMPs), or Current Good Manufacturing Practices (cGMPs), are standards enforced by the FDA and global regulatory bodies to ensure that products are consistently manufactured and controlled according to strict quality guidelines. Achieving GMP certification offers multiple benefits:

  • Regulatory Compliance: Ensuring adherence to legal requirements to avoid penalties and legal issues, including possible business shutdown.
  • Product Safety and Quality: Maintaining high standards to prevent contamination or adverse effects and ensuring the composition, efficacy, purity, and reliability of the products being manufactured.
  • Market Access: Facilitating entry into markets that require GMP certification.
  • Consumer Trust: Building confidence in your products by demonstrating a commitment to quality and safety. GMP Certification signals a commitment to quality.
ISO AGS 17020

Industry-Specific Benefits of GMP Certification

The benefits of GMP certification extend across various industries, offering tailored advantages that enhance operational excellence and market credibility:

  • Pharmaceutical Industry: Many pharmaceutical companies require their suppliers to be GMP certified to strengthen their supply chain quality and compliance.
  • Dietary Supplements: Ensure compliance with FDA regulations, gain access to global markets, and provide assurance of product safety and potency.
  • Cosmetics and Personal Care: Protect consumer health, meet regulatory requirements, and stand out in a competitive market.
  • Food and Beverage: Promote product safety, quality, and compliance with FDA and international standards.

Retailers, especially those selling products that directly impact consumer health and safety, often require their suppliers to have GMP certification. Many retailers including pharmacy chains; grocery, health and wellness stores; and cosmetic or beauty retailers require this evidence for consumer safety and confidence. GMP Certification can be a significant competitive advantage.

Why Choose cGMP Consulting for Your Certification Needs?

GMP certification requires a strong commitment to quality within your organization. cGMP Consulting provides comprehensive services that guide your organization through every step of becoming GMP compliant:

  • GMP Gap Assessments: Thorough evaluations to identify gaps and opportunities for improvement.
  • Quality Management System Development: Customized action plans to help your organization achieve compliance and demonstrate a culture of quality.
  • GMP Certification: For those organizations that have fully established GMP processes that are written, approved, and consistently followed.

Partner with Us: Expert Support for Your Compliance Needs

Contact us today to learn more about the process toward GMP certification and how we can position your organization for success in the competitive marketplace. Together, we can help you meet regulatory requirements while enhancing product safety and building consumer trust.

Are you Ready for GMP Certification?

We are excited to offer GMP Certification, helping qualified businesses demonstrate their commitment to quality, safety, and regulatory compliance. Achieving GMP certification means that the core elements of Good Manufacturing Practices (GMP)—specific to your industry—are fully implemented and consistently followed.

Before pursuing certification, it’s important to assess your level of readiness. We’ve developed a readiness questionnaire designed to evaluate your current processes and identify areas for improvement. Take the survey today and take the first step toward all the benefits of GMP Certification!

Take the GMP Readiness Questionnaire

Industry: (select all that apply)

For questions 1 - 13, select the option that best describes your current state

A. Yes – We have a fully established process that is written, approved, and followed consistently.

B. Somewhat – We have a process, but it needs improvement, approval, or is inconsistently followed.

C. No – We do not have this process in place.

1. Do you have a Quality Manual that describes your company’s product, quality objectives, and regulations you adhere to? *
2. Do you conduct and document management reviews for deviations, CAPAs, complaints, audits, trainings, change controls, and supplier performance? *
3. Do you have a Good Documentation Practices (GDP) procedure that includes record retention requirements? *
4. Do you have a Training Program that outlines training expectations for all roles within the company? *
5. Do you conduct and document annual GMP Training for all staff? *
6. Do you have a supplier approval procedure, and are all suppliers documented in the approved suppliers list? *
7. Do you have documented procedures for inspecting and testing incoming materials and finished product? *
8. Do you have defined procedures for manufacturing, maintenance and calibration? *
9. Do you have approved Batch Records that are completed, reviewed, and dispositioned for each batch you produce? *
10. Do you have a Change Control Policy? *
11. Do you document, investigate, and disposition all complaints and deviations? *
12. Do you perform internal audits on a predetermined schedule? *
13. Do you have a procedure for product holds and recalls? *

Take the GMP Readiness Questionnaire

Industry: (select all that apply)

For questions 1 - 13, select the option that best describes your current state

A. Yes – We have a fully established process that is written, approved, and followed consistently.

B. Somewhat – We have a process, but it needs improvement, approval, or is inconsistently followed.

C. No – We do not have this process in place.

1. Do you have a Quality Manual that describes your company’s product, quality objectives, and regulations you adhere to? *
2. Do you conduct and document management reviews for deviations, CAPAs, complaints, audits, trainings, change controls, and supplier performance? *
3. Do you have a Good Documentation Practices (GDP) procedure that includes record retention requirements? *
4. Do you have a Training Program that outlines training expectations for all roles within the company? *
5. Do you conduct and document annual GMP Training for all staff? *
6. Do you have a supplier approval procedure, and are all suppliers documented in the approved suppliers list? *
7. Do you have documented procedures for inspecting and testing incoming materials and finished product? *
8. Do you have defined procedures for manufacturing, maintenance and calibration? *
9. Do you have approved Batch Records that are completed, reviewed, and dispositioned for each batch you produce? *
10. Do you have a Change Control Policy? *
11. Do you document, investigate, and disposition all complaints and deviations? *
12. Do you perform internal audits on a predetermined schedule? *
13. Do you have a procedure for product holds and recalls? *

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