cGMP Consulting: Your Partner for cGMP Certification Audits 

In today’s competitive manufacturing landscape, adhering to current good manufacturing practices (cGMP) is not just a regulatory requirement, but a market entry requirement towards ensuring product safety and quality in many cases. Given our ISO/IEC 17020:2012 accreditation, we can offer the distinction of cGMP certification to qualified auditees.  Our comprehensive auditing services help your organization achieve and maintain compliance with the highest industry standards.  

Certification Signals Commitment to Quality

cGMPs are regulations enforced by the FDA and other international bodies to ensure that products are consistently produced and controlled according to quality standards. cGMP certification is essential for various reasons: 

• Regulatory Compliance: Ensuring adherence to legal requirements to avoid penalties and legal issues, including possible business shutdown. Regulatory agencies require cGMP compliance for pharmaceuticals, medical devices, food (including dietary supplements), and cosmetic products, to name a few. 
• Product Safety and Quality: Maintaining high standards to prevent contamination or adverse effects and ensuring the composition, efficacy, purity, and reliability of products. 
• Market Access: Facilitating entry into markets that require cGMP certification. 
• Consumer Trust: Building confidence in your products by demonstrating a commitment to quality and safety. Certification signals commitment to quality. 

There are numerous benefits to being cGMP certified, specific to each industry. For instance, to become a supplier to a pharmaceutical company, many organizations will now recommend or require cGMP certification to bring additional quality control to their supply chain. Retailers, especially those selling products that directly impact consumer health and safety, often require their suppliers to have cGMP certification. Many retailers including pharmacy chains; grocery, health and wellness stores; and cosmetic or beauty retailers require this evidence for consumer safety and confidence. Certification can be a significant competitive advantage. 

The cGMP Certification Audit Process

1. Preliminary Audit Activities: 
   • Determine purpose and scope of audit 
   • Gather relevant business information  
   • Determine applicable regulations and standards  
   • Understand audit history and possible unmitigated actions from regulatory agencies 
   • Prepare detailed audit agenda  
2. cGMP Certification Audits:
   • Opening meeting 
   • Site tour 
   • Conduct a comprehensive audit to assess compliance with cGMP regulations and standards 
   • Review documentation, including SOPs, batch records, and validation reports 
   • Hold closing meeting 
3. Certification: 
   • A recommendation will be made regarding your business using one of the three options: 
     1. Approved, cGMP Certified 
     2. Conditionally Approved 
     3. Not Approved 

• • Feedback will highlight areas of non-compliance and recommendations for improvement. These will be categorized as critical or non-critical.  
  • If conditionally approved, you will have the opportunity to remediate the observations. Once the corrective actions are found to be acceptable, you will then be cGMP Certified. 
  • Upon certification, a certificate will be issued as evidence. 

By registering with the FDA, you declare that you follow cGMP. The FDA evaluates compliance during the approval process and can audit your organization at any time without notice. To pass a cGMP certification audit or an FDA audit, you must have the systems and procedures, followed with documented evidence, such as batch records and exception reports in place and demonstrate use.  

It’s important to note that while cGMP Consulting can certify compliance, the FDA or other regulatory bodies have the final authority on cGMP compliance and do not recognize any certifications for cGMP.  

Pre and Post Audit Activities

Following an audit, or sometimes before a certification audit, our experts at cGMP Consulting can identify your compliance gaps and help remediate them by recommending and establishing robust and enduring solutions. This reduces your compliance risk and prepares you for any future audits, regardless of the auditing body. 

Additional Services We Offer: 

• Observation Remediation: Including quality system development, technical writing, validation work, etc. 
• cGMP Training: Educate your staff on cGMP requirements and best practices to ensure continued compliance and success within your organization.  
• Audit Readiness Training: For future audits with suppliers, customers, and/or regulatory agencies to increase the likelihood of a successful audit. 

Contact Us

Ready to show the world your manufacturing processes meet the highest standards of quality and compliance? Contact cGMP Consulting today to learn more about our cGMP certification auditing services and how we can help your organization succeed. Contact us today! 

At cGMP Consulting, we are dedicated to helping you achieve excellence in manufacturing through robust cGMP compliance. Partner with us to safeguard your products, enhance your reputation, and achieve regulatory success.