Good Manufacturing Practice (GMP) is a system for ensuring that pharmaceutical products are consistently produced and controlled according to quality standards. The standards are designed to minimize the risks that cannot be eliminated through testing the final products. GMP is governed by the Food and Drug Administration (FDA) to ensure the safety and integrity of drugs. GMP labs are used for many purposes- supporting translational research projects, participating in clinical trials, ramping up commercialization, etc. Any lab involved in commercializing a product or doing clinical trials must be GMP compliant.
GMP covers all aspects of production from the startling materials, premises, and equipment to the training and personal hygiene of the staff. Detailed written procedures must be documented to prove that correct procedures are consistently followed at each step in the manufacturing process- every time a product is made.
When building a GMP laboratory, the design of the facility is critical. GMP-compliant labs are becoming increasingly common as more organizations want to improve patient safety, even for products still under development. Building even a small GMP facility involves meeting strict regulatory standards. Typically, these standards result in increased project budgets. Extensive pre-planning, cost analysis and specialized consulting are necessary to mitigate challenges and missteps.
Many issues must be considered before even starting design. The product’s manufacturing process must be clearly defined in order to map space allocation, work flow, procedural documentation, equipment requirements and utility loads. Complex, dedicated HVAC systems must be designed for the space to provide easy access for maintenance and calibration.
Some clients prefer to involve regulatory officials from the FDA from the start. Having an official on board during the programming process can be a critical component to success.
Documentation is critical to approval. It is easy to underestimate the amount of documentation required for compliance. It is important to select contractors who have experience with GMP compliance documentation or who understand what is required.
The compliance process begins as soon as the project stars. Everything must be validated: a methodology for establishing documented evidence for each procedure, process, equipment, material, activity, or system. Validation is so critical because it is not possible to test 100% of the final product. Therefore, extreme measures are taken to validate the production process to ensure quality and safety.