From GMP API manufacturing to GMP quality control to the importance of radiolabeling, the pharmaceutical world is easily one that is overwhelmingly intricate and complex to the outside observer. But there is no doubt about it that the global pharmaceutical industry is hugely important – and often even lifesaving for large numbers of people. Things like GMP API manufacturing and GMP quality assurance help to make it an industry that continues to thrive in this day and age – and these same GMP API manufacturing protocols will insure that it thrives in the years that are to come as well.
And thrive it has. In total, the global pharmaceutical industry brings in a great deal of money, and the United States brings in a great deal of this money. In fact, it has been found that the United States alone holds up to forty five percent of the global market for pharmaceuticals on a world wide basis. But more important than the sale of these drugs and medications and treatments is the creation of them, the world of GMP API manufacturing here in the United States and beyond it, as GMP API manufacturing has spread to many different places all throughout the world as we know it.
When we look at the world of GMP API manufacturing, we find that protocols are strict. And for the safety of people consuming what is produced in the world of pharmaceuticals, this is an absolute necessity not to be taken lightly. The fallout of neglecting these protocols was seen in the year of 2012, before many of these protocols existed in the first place or were instituted on a wide scale throughout the United States and in the world as a whole.
In this year, there was an outbreak of fungal meningitis. Unfortunately, this outbreak led to the deaths of forty eight people and would likely have led to more if it was not traced back to one particular pharmacy in the United States. It was found that the outbreak of this form of meningitis occurred due to the fact that cleaning and maintenance procedures were not being followed as they should have been at the pharmacy where the outbreak originated in the first place. It was because of this that new clean room standards and standards for GMP storage conditions and other such procedures can into being in the world of GMP API manufacturing as a whole.
For instance, any given laboratory in the United States (or really anywhere) should be taking care to ensure that all of the on site equipment is in good working order at all times of operation. Even the fume hoods in laboratories need to be replaced eventually, even if they have been well taken care of the entire time that they have been in use (as, of course, they should be). In fact, among the one fifth of labs that are currently looking to or in the process of replacing their fume hoods, which, by the way, is an essential component in just about any lab environment, up to one third of these replacements are happening simply because the current fume hood has gotten too old to be safely and efficiently used, at least not as it once was.
Even during its years of operation, the typical laboratory fume hood should still be looked at on a regular basis, ideally at least once a year, if not even more frequently than that. It should be thoroughly inspected by an independent certifier. It is the job of this independent certifier in question to make sure that the airflow of the fume hood is meeting the necessary criteria, as deemed by the Cal/OSHA restrictions and regulations that are now in place.
Humidity is also an important thing to monitor in any given lab setting, as the humidity of a room can greatly impact the outcomes of certain types of pharmaceuticals, certain medications. Using electronic sensing devices has helped to make the close monitoring of this humidity more possible – and easier, of course – than ever before, but it is still not something to take for granted by any means, as pharmaceuticals are so hugely important in our world.