What the Baltimore Vaccine Incident Can Teach Us About GMP

After over a year of quarantine restrictions, many of us are fed up with COVID-19 and can’t wait to receive the vaccine. It can be frustrating waiting for the rollout to complete and even more so when some of the vaccine doses end up wasted.

That’s exactly what happened in Baltimore recently. The U.S. Food and Drug Administration recently reported an accident at a plant that made 75 million doses of the Johnson & Johnson coronavirus vaccine inoperable. What exactly happened, and what lessons can we learn as a medical industry to prevent future similar incidents?

It’s worth discussing what exactly led to the Baltimore case and the costs of failing to maintain up-to-date good manufacturing practice (GMP).

What Happened?

The factory in Baltimore contaminated the ingredients for the vaccine. Specifically, it failed to seal off the preparation area properly and accidentally moved production waste through it. The F.D.A. advised the plant to throw out 60 million doses as a result.

In addition, another 15 million doses could have been contaminated at another southeastern Baltimore plant. This second factory was operated by Emergent BioSolutions, a subcontractor for Johnson & Johnson that operated as a government contractor as well for a long time.

10 million doses were determined to be safe by regulators for both internal use and export, mostly because of the continuing need for COVID-19 relief and the safer conditions in which they were produced. Still, the incident represents an unfortunate loss, especially as millions more are still waiting for their vaccinations.

Possible Cross-Contamination

Emergent also manages the creation of vaccines for another vaccine producer, AstraZeneca. The F.D.A. notes that the company failed to separate production lines for AstraZeneca and Johnson & Johnson, resulting in more potential cross-contamination that could render even more doses unusable.

To be specific, while the factory did prepare ingredients separately, workers began using the same warehouse for both doses once production began. Indeed, back in March, the factory discovered traces of key ingredients from the AstraZeneca vaccine in the Johnson & Johnson version and had to throw millions of doses out.

High Excess Waste

The accelerated nature of vaccine production also generated plenty of medical waste, and Emergent allowed its workers through official procedure to move it through the warehouse in wheeled containers, leading to the 60 million doses lost according to the F.D.A.

Concerns Over Previous Infractions

Many regulators were aware of problems at Emergent even before the incident. In September last year, for example, inspectors noticed crowded manufacturing zones with too many equipment and supplies in the same place.

There were also inadequate quality assurance practices and a general disregard for GMP, as the staff at the factory changed significantly over the course of only a few months.

What Was Done In Response?

F.D.A. regulators have since closed down the factory for a few months as investigations are underway into:

• The exact cause of the contamination
• When the facility may reopen safely
• Measures for the other 170 million AstraZeneca and Johnson & Johnson vaccines also produced by Emergent

In the meantime, AstraZeneca production has ceased at the Emergent plants, and Johnson & Johnson vaccines can only continue under the direct supervision of Johnson & Johnson.

Regulators believed that the overloading of the facility’s capacity and overall lax procedures at the factory were partly to account for the high number of disqualified doses, as testing may not have picked up on every case of contamination.

The memo from the F.D.A. also states that even a low contamination level might have an impact on the safety or effectiveness of the vaccine, as no scientific experiments or evidence conclude the opposite.

It’s also worth noting that Emergent was a recipient of government aid totaling about $200 million as of this April, though payments have recently stopped.

What Can We Learn?

Just as important is the response that Emergent and other medical industry entities should make regarding good manufacturing practices. On top of costly resource losses and action from regulators like the F.D.A., incidents like the one in Baltimore damage your reputation among your customers, whose trust matters immensely in such a high-risk industry like medicine.

GMP and CGMP

The answer is good manufacturing practices (GMP), the actions you take to ensure that your output as a facility is consistent and controlled to the overall standards of the business. GMP can apply to almost any market, from food to cosmetics, and it matters especially for the medical field.

Companies focusing on GMP implement proper monitoring and control tools in their facilities. Having a proper GMP system in place prevents incidents like cross-contamination, mislabeling, and other mistakes that negatively impact the usefulness or safety of your pharmaceuticals. They also protect both you, the customer, and the environment from harm and help you adhere to government regulations.

The many facets of GMP alignment include:

• Sanitation. Facilities need strong cleaning and hygiene policies in place to prevent contamination.
• Maintenance. Any equipment in the facility must be maintained and function as intended. Regular cleaning and storage, as well as checkups to prevent malfunctioning, is a must.
• Raw materials. Keeping track of stock and labeling where materials come from is the best way to ensure quality.
• Staff training. Everyone working in a pharmaceutical facility must be properly trained in the GMP principles and policies of the company. Up-to-date knowledge is expected.
• Audits. All facilities must be inspected and audited occasionally. These checks will make sure that your business is continuing to align with the guidelines.
• General quality control. From food to medicine, the F.D.A. requires that products coming out of a facility to be properly processed and not expired.

There’s also another term officially designated by the F.D.A. called “current Good Manufacturing Practices” or “CGMP.” Because medical practices and knowledge evolve, sometimes faster than the law can keep up, CGMP refers to how GMP itself changes with time.

Process Validation

It doesn’t matter how much confidence you have in a new product, vaccine, or medicine. A single testing phase isn’t enough to catch all the potential problems that could arise. That’s the philosophy behind process validation, another essential step in medical compliance.

Process validation involves the collection and use of data to check every step of the pharmaceutical process, from product design to commercial production all the way to discontinuation. The goal is to always have scientific evidence that the process is capable of delivering safe and effective products.

We often refer to process validation in the form of three phases:

• Design, or defining the commercial manufacturing process.
• Qualification, to ensure that the process is reproducible and able to meet the demands of commercial manufacturing.
• Verification, ongoing assurance that proper controls are maintained during manufacturing.

These steps would have helped prevent incidents like vaccine contamination, and the Baltimore plant occurrence is a testament to the importance of good manufacturing practices in the medical field.

Ensure Your Process Validation Is FDA-Compliant

Process validation plays an important role in ensuring all drugs, medical devices, and other related products are up to the strict standards established by the FDA. 

It also provides your teams with a consistent set of rules for validating the processes you use should something go wrong.

Are you looking to keep your knowledge up to date? Sign up for our process validation course today.