cGMP Regulatory Review
cGMA is expert in providing primary cGMP regulatory review documentation for manufacturing facilities and environments. These typically include: Floor Plans at all levels indicating major pieces of process equipment, Flow Plans indicating flows of personnel, visitors, and staff, materials including raw materials and supplies, process intermediates, samples, finished product, soiled and clean equipment, and wastes; Air Classification Plans, Air Pressurization Plans, Air Handling Unit Zoning Plans, and where applicable, Electrical Classification Plans.
These documents form the basis of regulatory agency review of proposed manufacturing facilities, or alterations thereto. cGMA can assist with arrangements, submissions, and presentations for a FDA Type C meeting for the purposes of design review.
Additionally, cGMA provides review and commentary on cGMP regulatory approaches and expectations for capital facility designs provided by others, offering a wealth of experiences at a wide range of clients, facilities, and approaches.
These documents form the basis of regulatory agency review of proposed manufacturing facilities, or alterations thereto. cGMA can assist with arrangements, submissions, and presentations for a FDA Type C meeting for the purposes of design review.
Additionally, cGMA provides review and commentary on cGMP regulatory approaches and expectations for capital facility designs provided by others, offering a wealth of experiences at a wide range of clients, facilities, and approaches.