Compliance Architects provides comprehensive, practical cGMP/GMP consulting services to the pharmaceutical, medical device, biopharmaceutical, dietary supplement, and related industries. Our highly experienced FDA GMP consultants have gained expertise in FDA-regulated plant-floor manufacturing by working with the world’s leading companies.  Each brings a wealth of experience about the “c” in cGMPs to help you plan, implement, and maintain effective business systems while ensuring your company’s GMP compliance.

What are the cGMPs?

cGMP refers to the Current Good Manufacturing Practice regulations, which are found in 21 CFR 211 (pharmaceuticals), 21 CFR 820 (medical devices), and 21 CFR 111 (dietary supplements) as established by the US Food and Drug Administration (FDA). At their core, the CGMPs outline the requirements for systems that ensure the proper design, monitoring, and control of manufacturing processes and facilities. If properly implemented, these systems help prevent poor quality issues, such as contamination, failures, and errors.

The Benefits of Hiring a Qualified GMP Consultant

Because the cGMP requirements are designed to be flexible, it is up to each company to determine the most effective way to implement the necessary controls and systems. It’s also important to note that the cGMPs are the minimum requirements and are enhanced through guidance and enforcement practice.

Although the FDA publishes regulations and guidance documents for the industry in the Federal Register, they won’t hold your hand or walk you through the details to ensure you achieve compliance.

Our GMP Consultants bring expertise and experience your business may not have. By employing scientifically sound and proven techniques and methods, companies can leverage modern technologies and innovative approaches to achieve higher quality.

The result of our efforts is production facilities in good condition, properly maintained and calibrated equipment, qualified and fully trained employees, and reliable, reproducible, and adequately documented processes.

Don’t Take Chances with FDA Compliance

Contact us today using the form on the right, and one of our Senior GMP Consultants will be in touch with you.