Designing manufacturing facilities that meet guidelines
cGMP requirements exist to establish the foundation for drug product quality. Manufacturing facilities that must comply with Current Good Manufacturing Practice are specifically designed to allow our clients to adhere to cGMP regulations, enforced by the FDA. These regulations are minimum requirements, and we understand many pharmaceutical manufacturers are implementing more comprehensive approaches that exceed these minimum standards.
Within the Code of Federal Regulations (CFR) Title 21, exists “Subpart C – Building and Facilities” which outlines specific criteria for how a cGMP facility is to be constructed. When your building is designed and constructed correctly, with adequate space, environmental containment, and cleanable finishes, this allows you to execute many of your Standard Operating Procedures (SOP) with ease.
Experience has taught us that there is no cookie-cutter facility design and an in depth understanding of your current and future manufacturing processes is critical for your remodel or new project to be a success.