Implementing Good Manufacturing Practices: Pharmaceutical GMPs

Further, the Quality Control Unit must investigate when a batch possibly fails testing or "unexpected results or trends."  A failure can be related to the "quality of components, containers, closures, in-process materials, and finished product." These parts of the pharmaceutical manufacturing process are available to test for sterility, micro-organisms, content uniformity, impurities, endotoxins, and more.  To add to this, malfunctions and equipment defects within the manufacturing processes are investigated to locate and isolate any potentially affected batches. Overall, these measures aim to minimize the risk of contamination, mislabeling, and inaccurate active ingredient percentage.

During the production of pharmaceuticals, all aspects of the process should be designed to minimize the threat of contamination. For example, the FDA requires a cleanroom environment for sterile drug production with "cascading air quality" through the facility. This phrase refers to production spaces placed under higher positive air pressure than the surrounding rooms, which are also under more pressure than standard room air.  This design (along with sterilization PPE, tools & guidelines) helps keep contaminants from entering the space through open airways. 

However, since the QCU is designed to operate independently, most facilities have a dedicated GMP room(s) to handle these procedures.   For pharmaceutical manufacturers, if their supply increases, the size of their QCU will need to grow with it.  Therefore, as their production increases over time, manufacturers will eventually need to provide additional GMP space to meet these requirements. Luckily, Panel Built, Inc.'s modular wall systems and panelized cleanrooms are the perfect solutions for facilities looking to improve their GMP whenever needed. 

One of the prevailing aspects of GMP is the importance of creating a clean environment throughout production.  With Panel Built's highly adaptable wall system, each of these spaces can be created with our system's semi-permanent design.  The walls use a non-progressive, panelized method with a binder-post connection system. In addition to connecting one panel to another, the binder posts act as a raceway for electrical or data wiring. This system allows for an endless array of layout options, allow Panel Built to design our systems 100% to customer specifications. 

As we mentioned, generally, GMP environments are placed under positive air pressure (air is forced out of the room if opened to the outside).   To achieve this, air constantly moves into the system through a HEPA filtration system or Fan Filter Units (FFU). The outside air is purified before entering the cleanroom.  Then, existing air inside the cleanroom goes into an air return chase either built into a wall panel or formed from a double-wall system. After entering the chase, the air is either directed outside or pushed back through the HEPA filter system.