Pharmaceutical manufacturing and transportation is an industry that requires a high level of oversight to make sure the medications being manufactured meet the required specifications and that they are being transported correctly to ensure maximum efficacy upon delivery. For many patients, these medications can do everything from improve the quality of their life to ensure their survival, which is what makes these regulations so important.
Special guest post by Megan Ray Nichols
What do you need to understand about safety in pharmaceutical manufacturing and transportation?
The first step in pharmaceutical safety happens in the manufacturing stage. In the United States, manufacturers are constantly under scrutiny by the FDA (Food and Drug Administration) to ensure each batch of a medication meets the same quality and efficacy standards as the previous batches.
Pharmaceutical companies that produce their products in the United States are subject to the FDA’s Current Good Manufacturing Practice, or CGMP. These practices ensure the company is using the highest-quality raw products as well as up-to-date manufacturing technology to provide a standard level of quality across all of their products.
This is essential, especially for over-the-counter medications, because most customers don’t have the skills or equipment necessary to test their medication and make they’re safe and effective. For a bottle of Tylenol, for example, most people don’t look closely enough to see anything other than they’ve got the proper number of pills in hand. It’s not laziness on the consumer’s part, but rather a sign of the trust they’ve placed in the manufacturer.
Safety plays a significant role in the transportation of medications. Once the medication is complete and safe to transport, the problem becomes a logistical one. A number of different variables have to be taken into account, including:
· Form: In what form are these drugs being transported? Solid — in the form of pills or powder — or liquid, in IV bags or sterile bottles? Are they gaseous substances that need to be transported in pressurized containers?
· Type: Security for the shipment of controlled substances should be much higher because they are most likely to be stolen and sold on the street.
· Requirements: Do the medications have to be kept at a certain temperature to maintain safety and efficacy?
· Destination: Where are the medications going? Will there be multiple transport changes (such as truck to plane) for final delivery, or will the products remain in the same vehicle for their entire journey?
These variables and many more have to be taken into account when planning the best way to produce and deliver pharmaceutical products. Items that have to be kept at a low temperature, for example, will need to be more carefully monitored than those that can be stored at room temperature.
Security at loading and unloading points is also a necessity — especially for controlled substances at risk for theft.
Customer expectations are higher than they’ve ever been, in part because they know they can put their trust in these companies and that there are laws in place to ensure every Tylenol or Excedrin they take is going to be close to identical. That trust comes from experience — they know that if there is a problem, the product will be removed until it can be fixed, like the cross-contamination problem that Novartis experienced in 2012 with Excedrin and four of its other over-the-counter products.
The applicable safety regulations are the key to making sure the trust of these consumers is not misplaced.
Regulations concerning the safety of pharmaceutical manufacturing and transportation aren’t there just to pacify bureaucrats and legislators — they’re in place to ensure that safe and effective medication is available to patients around the world. By ensuring this safety throughout both the manufacturing and shipping processes, we can help to ensure that no matter their destination, all of these medications arrive where they’re needed most in time to help.