Global Auditing Services offered by cGMP Consulting 

In the dynamic landscape of global regulations, maintaining compliance with Good Manufacturing Practices (GMP) is paramount. cGMP Consulting stands at the forefront, offering top-notch auditing services that empower companies to enhance product quality, ensure regulatory compliance, and build a foundation of trust in the market. GMP auditing is a critical component of quality assurance, involving the systematic examination of manufacturing processes, facilities, and documentation to ensure adherence to established GMP standards specified by each industry.  

cGMP Consulting specializes in conducting thorough GMP audits within client organizations. Our seasoned auditors delve into every aspect of manufacturing, evaluating processes, quality control measures, documentation practices, and personnel training. These audits serve as a proactive approach, identifying potential issues before they escalate, thereby promoting a continuous improvement culture. 

Understanding that every organization is unique, cGMP Consulting provides tailored compliance audits. These audits go beyond the standard checklist, addressing specific challenges and opportunities within each client’s operations. The result is a customized roadmap for continuous improvement and sustained GMP compliance. 

Internal GMP Audits  

Internal GMP audits or Self-Inspections are an integral part of a robust Quality Management System. Our expert auditors will perform a targeted inspection analyzing processes, documentation, and systems to identify potential quality systems gaps before regulators do. This helps rectify potential issues and promotes a quality culture.  

Many companies opt to bring in GMP consultants to perform these audits; one benefit includes bringing in a “different set of eyes” as often clients get used to seeing things being done the same way. A consultant can bring a different perspective and offer solutions that come from seeing a variety of similar situations throughout industry. Our auditors have seen hundreds of companies worldwide and can share valuable insight into industry standards and best practices.  

Pre-Approval Inspection (PAI) Readiness Audit 

Regulatory agencies conduct PAIs to confirm that a manufacturing site named in a drug application can manufacture the product and that the data submitted in the application is complete and accurate.  

Before being audited by a regulatory authority, an important part of the drug approval process, we can help you prepare. We will focus on the facilities and processes related to the manufacturing of pharmaceuticals, human or animal food, dietary supplements, APIs, critical starting materials, intermediates, solvents, drug products, etc. We can help you fill any gaps to meet regulatory standards before a product is approved for market distribution.  

Supplier Qualification Audits 

Avoid entering into a supplier agreement without proper vetting. Qualification audits of potential suppliers of any starting materials are a GMP requirement and a critical step for ensuring product quality before your manufacturing process has even begun.  

These could be any type of supplier including raw materials, excipients, components, intermediates, APIs, drug products, etc. A quality product cannot be made with subpar or inconsistently supplied materials. Poor incoming materials quality can lead to problems such as product loss, production stoppage, regulatory actions, recalls, and field alerts, to name a few. This audit will include an examination of the supplier’s facilities, processes, and quality management systems and ensure the quality and safety of materials sourced from external sources. 

Many companies do not employ the appropriate resources or qualified auditors, so they prefer to hire GMP consultants. Often this is a less costly option than hiring, training, and retaining full-time auditors.  

Due Diligence Audits 

A due diligence audit is a process that provides an assessment snapshot of the potential regulatory risks, liabilities, and compliance gaps for the company in review. The scope of the audit may include examining the company’s regulatory strategy, internal workings, and audit/inspection records. It may also involve assessing the company’s remediation processes/procedures. cGMP Consulting can work with you to determine the desired scope is being addressed.  

Routine Supplier Audits 

Per regulations, companies are required to have a system in place to monitor its suppliers’ continued GMP compliance. This can be conducted using a risk-based approach if that is important to your organization. Routine Supplier Audits ensure timely and thorough monitoring of your supplier’s quality. We can conduct on your behalf with minimal disruption to day-to-day activities. 

GMP Gap Assessments 

We can identify current good practices and areas that need improvement to become GMP compliant. This assessment encompasses various aspects of manufacturing, including processes, documentation, personnel training, and quality control. 

We have extensive experience with companies moving from a non-GMP environment to become GMP compliant to attract new business or sell in regulated industries. 

GMP consulting can perform a comprehensive Gap Assessment to identify current good practices and areas that will need to improve in order become GMP compliant and therefore increase the chances to obtain regulatory approval for the new GMP certified product or services. 

Expectations and Remediations 

Before any audit, purpose and scope will be agreed upon. Daily feedback will be provided during the 1-5 day audit, depending on the complexities of the facility and process. A comprehensive report will be presented upon project completion.  

Once the gaps have been identified, a project plan is developed with the client to address each gap. Our subject matter experts will guide you through the remediation, implementation, and training.  

Regardless of the type, GMP audits play a crucial role in maintaining product quality, ensuring consumer safety, and meeting regulatory requirements. It’s important for organizations to conduct regular audits and address any non-compliance issues promptly. 

Why Choose cGMP Consulting?  

• Trusted partner in elevating manufacturing standards 
• Comprehensive suite of GMP auditing services 
• Expertise to navigate regulatory complexities 
• Culture of continuous improvement 
• Delivery of products with the highest quality to market 

At cGMP Consulting, excellence in GMP compliance is not just a goal; it’s a shared journey towards industry leadership and consumer trust. 

Luis Nieves, Senior Auditor