CGMP Certification

What is CGMP Certification?

Current Good Manufacturing Practices, abbreviated cGMP, refer to established best practices for food and dietary supplement manufacturers. In the US, cGMP means adhering to 21 CFR 111 for dietary supplements or 21 CFR 117 for food products in addition to applicable portions of Codex Alimentarius. GMPs are mandated by the FDA and so must be followed by manufacturers. Many companies go a step further and seek the distinctive cGMP certification by an accredited body in order to differentiate themselves or open up new lines of business. Avert works with manufacturers to create or enhance their quality management systems and supports them throughout the certification process ultimately working with reputable firms such as SGS and NSF to secure the certification or registration.

Why is this certification important?

Because dietary supplements are ingested and pose similar risk to foods, dietary supplements historically were considered a type of food and thus had the same requirements as foods.  GMPs for the food and dietary supplement industry were originally codified in 1986 under 21 CFR 110: Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food.

Why the little “c”?  When FDA published the first set of GMPs specific for dietary supplements in 2007 under 21 CFR 111, they were titled: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, Or Holding Operations For Dietary Supplements.  Today, GMP and cGMP can be used interchangeably as each refers to the proper design, monitoring, and control of manufacturing processes and facilities. 

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How Avert Helps with Your CGMP Certification

Avert works with your team to facilitate your cGMP certification program including:

  • Research and development of new products and processes
  • Comprehensive program development, audit preparation, and training
  • Complete Quality Management System (QMS) creation and development encompassing:
    • Administrative and Regulatory
    • Corrective and Preventive Action
    • Equipment and Facilities
    • Laboratory Controls
    • Production and Process Controls
    • Quality Management
    • Food Safety
    • Supply Chain
    • Warehouse and Distribution
  • Ongoing management of the QMS including internal audits and continuous improvement

Let's Talk About It!

Don’t let your competitors get the upper hand! Show your customers your commitment to quality and product safety through cGMP registration of your facility and processes. Avert will design and implement your quality management system from the ground up and provide appropriate training so your team is positioned to maintain and improve your quality management systems. Call or email us today!
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