Biopharmaceutical GMP Consulting Services
Compliance Architects® provides comprehensive, practical cGMP / GMP consulting services to the biopharmaceutical industry. Our highly-experienced FDA GMP consultants learned the ropes of FDA-regulated plant-floor manufacturing in the world’s leading FDA-regulated companies. Each bring 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 assure proper design, monitoring, and control of manufacturing processes and facilities. If properly put into practice, the systems help to prevent poor quality issues such as contamination, failures, and errors.
The Benefits of Hiring a Qualified Biopharmaceutical GMP Consultant
Because the cGMP requirements are designed to be flexible, it is up to each company to decide how best 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.
And although the FDA publishes regulations and guidance documents for 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 a level of expertise and experience that your business may not currently have. By using scientifically sound, proven techniques and methods we enable companies to use modern technologies and innovative approaches to achieve higher quality.
The result of our efforts is production facilities that are in good condition, equipment that is properly maintained and calibrated, employees who are qualified and fully trained, and processes that are reliable, reproducible, and properly documented.
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.