Coronavirus 2020: Everything Pharmaceutical Personnel Should Know

The high-profile coronavirus disease of 2020, also known as SARS-CoV2 and COVID-19, is a major respiratory disease. First detected in the Wuhan City of China, the virus has spread to other nations internationally and is now considered by experts to be a global pandemic.

It has become a serious threat to U.S. citizens as well. Rapid detection of the virus and the proper management of medical resources is necessary to maintain safety.

Now that the number of confirmed worldwide cases reaches 90,000 and the first few deaths from the virus have transpired in the U.S., the people, the U.S. Food and Drug Administration (FDA), and the pharmaceutical industry are making preparations to mitigate the consequences.

What the FDA Is Doing

The FDA is rapidly developing new policies to meet the challenges presented by coronavirus. To date, they have done so for labs developing diagnostics for the virus to ensure rapid and accessible testing in the U.S.

The policies include labs that already use newly-developed diagnostics before the FDA has completed the Emergency Use Authorization (EUA) review. The FDA issues an EUA to permit the use of medical products when a public health emergency is on the line.

The Secretary of Health and Human Services confirmed these authorized emergency uses for detecting COVID-19 on February 4th, 2020. Essentially, coronavirus testing is now allowed even outside the Center for Disease Control (CDC) and before agency review.

The FDA and CDC will also create more respirators, including N95s, for use by health care personnel. Previously, these devices were for industrial purposes only.

How Is COVID-19 Affecting the Pharmaceutical Industry?

Supply chain issues are one of the biggest problems that the pharmaceutical industry is facing. With a large portion of active pharmaceutical ingredients (APIs) being manufactured in China, a slowdown in production capacity could lead to potential drug shortages.

The federal government is aware of this problem, and specific individuals within the Trump Administration have proposed the need to shift manufacturing and supply chains back to the U.S.

The FDA is asking manufacturers to evaluate their supply chains and notify the FDA of anticipated shortages. While there are no shortages yet, the FDA has observed that at least 20 drugs with active ingredients made in China may be impacted.

This issue could affect medical devices as well. A large portion of essential medical devices are made in China, and, like APIs, they are prone to potential supply chain issues.

Other companies may experience workforce challenges as COVID-19 forces a large portion of their workers to quarantine themselves during recovery. It’s vital that your company has an appropriate health and safety plan in place should an outbreak occur.

Other Aspects of Pharmaceutical Industry Biogenics

The FDA is not aware of any gene therapies that could be jeopardized by the virus. Likewise, no shortages of biologics have been identified yet.

Blood Transfusions

It’s still unknown whether COVID-19 can spread through blood transfusions. However, respiratory viruses, in general, usually do not spread through blood. There have been no reported cases of such infections yet.

Food Safety

The FDA has not received any reports of the virus spreading through the food supply yet, but the organization still emphasizes the importance of hygienic food preparation.

Prepare for COVID-19 With CfPIE’s Pharmaceutical Training Courses

The Center for Professional Innovation and Education works with leading pharmaceutical companies, medical device manufacturers, biotechs, and more to help them ensure that their key personnel is up to date on the latest best practices, industry trends, and more.

COVID-19 presents a variety of risks that medical companies need to be aware of. Whether it’s affecting your supply chains, the drugs you manufacture, medical device availability, or the internal policies that your company relies on, you must be prepared to handle these issues as they occur.

We are offering a variety of pharmaceutical, medical device, and biotech training courses in the coming months that can provide you with the knowledge you need to protect your company and its key personnel. 

Here are just a few of the courses we recommend:

• Best Practices for an Effective Cleaning Validation Program
• Cleanroom Fundamentals - Regulation, Science, Design, Practice, Operation & Management
• Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products
• Good Laboratory Practices (GLP) for Nonclinical Laboratory Studies™

Please contact CfPIE by calling 1-610-648-7550 or [email protected] if you have any questions at all about the courses we offer and how you can prepare for COVID-19.