The pharmaceutical industry is a large one in the United States, and countless millions of Americans are currently on prescription drugs or have the need for them. This, in turn, means that today’s pharma labs are held to high standards of manufacturing and distributing prescription drugs and related materials, and this ranges from API GMP (active pharmaceutical ingredients good manufacturing practices) to radiolabeling, replacing fume hoods in the lab, maintaining chemical purity, and even 14c labeling. Today’s pharma industry is held to those high standards for API GMP and more to ensure that today’s pharma products are both safe and effective for paying American consumers. After all, prescription drugs are trusted to be put into the body and have a positive effect, and improperly made products may be a real problem. A responsible lab head technician will ensure that API GMP is upheld, and demonstrate that API GMP when inspectors arrive to look over the facility.
Tracking and Logging Data
Maintaining API GMP includes requiring staff members to carefully track everything that happens. Experiments in the lab, producing final products, storing and distributing them, and even lab conditions such as air humidity should be tracked and that data should be logged. Why? This storehouse of data may show a business owner if the lab is slacking off on its standards, and if a problem occurs, this data makes it much easier to determine the cause. For example, if a wholesale customer returns faulty products and reports customer complaints, this storehouse of data allows researchers to determine what went wrong when they made that product. All of that logged data ensures that a problem can be diagnosed and that the problem won’t occur again. And if inventory goes missing, data may help identify where it went. Tracking production also prevents an excess of product being made, as excess inventory may be a waste of money to produce. Finally, when an inspection is taking place, the staff at a lab will need a way to prove their API GMP, and showing inspectors that data is a fine way to do this.
Examples of Good Manufacturing Processes
It is clear that the technicians in a lab are working hard to track what they are doing and stay on top of developing problems. How might this be done? Many labs are regularly changing their fume hoods to keep performance optimal, and such a fume hood should be checked at last one each year by an independent certifier. This inspector will determine if that fume hood has the correct air flow to meet Cal/OSHA criteria, and make a note if it does not. A recent survey in the industry, meanwhile, has found that one in five labs was making plans at the time to replace their fume hood. In one of three of those cases, the fume hood was being replaced due to simple old age. Even in the complex pharma industry, something as mundane as replacing old hardware is critical.
Even the very air in a lab should be monitored and controlled. The lab’s clean rooms in particular must have minimal air particles and a specific level of humidity, and these standards are quite strict (and not without reason). In a typical urban area, for reference, the air may contain around 35 million particles per cubic meter of air. Each of those particles will be 0.5 micrometers in diameter or more. In an ISO 1 clean room, by contrast, that cubic meter of air will have, at most, 12 airborne particles that are 0.3 micrometers in diameter or less. Particles bigger than that aren’t even allowed inside the clean room’s air at all. And thanks to modern electronic sensing devices, it is possible for a lab’s staff to control the clean room’s humidity level within 1%. This allows substances with delicate tolerances to avoid contamination.