cGMP – Current Good Manufacturing Practices Certification
- Industry: Food & Beverage Manufacturing and Safety
About cGMP
Current Good Manufacturing Practices (cGMP) are a set of regulations enforced by regulatory agencies like the FDA. They provide a framework for consistent, safe, and high-quality manufacturing of products across industries including food, pharmaceuticals, and cosmetics.
A cGMP audit and a GMP audit are related but slightly different in terms of scope and focus.
A cGMP audit is where the “current” aspect signifies that the audit evaluates compliance with the most up-to-date GMP standards at the time of the audit. cGMP audits are more focused on dietary supplements which are regulated in the U.S. by the Food and Drug Administration (FDA). The purpose of a cGMP audit is to ensure that dietary supplement manufacturers adhere to the current GMP requirements related to production, testing, and distribution.
A GMP audit is conducted to assess whether a manufacturing facility, process, or system meets requirements and regulations for good manufacturing practices. GMP requirements ensure that products are consistently produced and controlled to meet quality and food safety standards appropriate for their intended use. GMP audits typically cover a wide range of areas, including facility design, equipment qualification, personnel training, documentation, quality control, and product testing.
Why cGMP Certification Matters
- Regulatory Compliance: Confirms adherence to FDA-mandated cGMP standards, reducing the risk of fines, recalls, or shutdowns.
- Product Quality & Safety: Ensures every product meets strict standards for purity, potency, and identity—protecting both consumers and your business.
- Process Consistency: Validates that manufacturing operations are repeatable, controlled, and documented—minimizing variability and errors.
- Ingredient Integrity: Verifies that raw materials are properly sourced, tested, and meet specifications for quality and safety.
- Comprehensive Documentation: Establishes traceability across the supply chain through robust batch records and testing protocols.
- Brand Credibility: Positions your company as a reliable, quality-focused partner in the eyes of regulators, retailers, and consumers.
EAGLE’s cGMP Audit Services
We conduct independent cGMP audits across diverse manufacturing sectors. Our detailed assessments help you identify gaps, improve documentation, and streamline practices to align with cGMP certification.
Benefits of Our Auditing Approach
Expertise:
Our auditors possess deep industry knowledge and understand the nuances of your unique needs.
Tailored Solutions:
We customize our auditing approach to fit your organization's specific needs and operational context.
Partners in Success:
We pride ourselves in becoming your partner in achieving your objectives while taking a consultative approach.
Contact us today to begin the process and take the first step toward achieving certification.