Should FDA Pre-Approval Inspection of Manufacturing Plants That Make Over-the-Counter Drugs Be Mandatory?

Regulatory Gaps and Lapses in Inspections

The FDA ensures the quality of manufacturing facilities through several processes. One of the primary methods is conducting an FDA pre approval inspection of facilities for any manufacturer producing pharmaceutical products to ensure they are in full compliance with all regulatory requirements. FDA’s Good Manufacturing Practices (GMP) are central to these inspections, and companies must fully comply.

However, the FDA’s processes have been criticized for crucial regulatory gaps, such as controlling imports of drug products coming from overseas. Additionally, some have criticized FDA inspection frequency and the inspection process itself.

Recent Contamination Incident

Safety practices in pharmaceutical manufacturing have come under scrutiny following notable instances of unsafe practices for over-the-counter drugs. One specific incident reflects lacking inspections for imported over-the-counter medications, resulting in blindness and degrading vision from eye drops contaminated with antibiotic-resistant bacteria.

Recently, an Indian company that manufactures artificial tears was suspected of being contaminated with drug-resistant bacteria capable of degrading vision while also being contagious.

Most notably, this bacteria spread person-to-person at a long-term care center in Connecticut. As a result, many patients still have degraded vision. As a result, the  FDA blocked imports of the eye drops and issued a recall.

As a result, the FDA’s inspection processes for over-the-counter drugs are now under the microscope. Should inspections be mandatory? Why was this specific manufacturer not inspected and gone through necessary quality checks before its products were made available to consumers?

Changes may take some time to be drafted, agreed upon, and implemented. In the meantime, companies domestic and abroad can help prevent potential issues and stay ahead of possible changes by providing employees with FDA compliance training.

Concerns and Solutions

Allowing the import of contaminated eye drops brought FDA’s inspection and enforcement processes into the spotlight. It’s clear the FDA’s processes are not perfect, especially concerning imported medication and nonprescription drug products.

Many critics have said that the FDA needs to do more to improve safety practices in pharmaceutical manufacturing, domestically and abroad. The incident we discussed above is a prime example, and it’s not the only example of lacking processes.

The U.S. Government Accountability Office (GAO), a federal agency, has raised several concerns regarding FDA’s processes and made specific recommendations. The GAO has provided three detailed recommendations for executive action:

1. Incorporate leading practices identified by the GAO for designing a program to evaluate the effectiveness and efficiency of unannounced inspections in foreign facilities.
2. Evaluate the costs and effectiveness of translation services to be made available during foreign inspections to improve these inspections.
3. Develop new strategies for recruiting, training, and retaining investigators capable of specializing in foreign drug inspections.

The last recommendation aims to solve a primary concern — an insufficient workforce for conducting inspections in foreign manufacturing facilities. As a result, the FDA has a significant backlog of foreign companies to inspect, but many over-the-country companies are still exporting products to the US.

It’s clear the FDA needs to ensure any company that will be manufacturing drugs for the US meets compliance requirements for the safety of consumers. While the FDA may have gaps and lapses, they can also be corrected by taking key actions to improve processes and expand its workforce.

The importance of FDA regulatory compliance training

Pharmaceutical companies need to stay up to date with FDA regulations. This includes hiring qualified personnel, investing in training and education, and utilizing available FDA resources.

FDA compliance changes frequently, and your employees must stay on top of any changes affecting their roles. Compliance training keeps your employees updated with the latest CGMP requirements to help you avoid fines or product quality issues.

While abiding by FDA regulatory compliance requirements is necessary, providing ongoing training also improves your manufacturing processes. In addition, your teams will be aware of process changes that reflect significant studies and analyses from the FDA, allowing for efficiency and effectiveness enhancements throughout the company.

Whether the FDA will make pre-approval mandatory for over-the-counter drugs remains to be seen. However, manufacturers can stay ahead of potential changes by providing compliance training.

CfPIE is a leading provider of life science training, including Good Manufacturing Practices (GMP) courses that keep your workforce in full compliance. Learn more today about how our programs can help keep you in compliance and operating effectively.

About CfPIE

The Center for Professional Innovation and Education (CfPIE) is the global leader in life sciences training, providing specialized courses for pharma/biotech, medical device, and skin/cosmetics topics. Classroom and custom on-site formats, and certification programs help improve personal skills, maintain regulatory compliance, and advance careers. Small class sizes and industry-active course directors promote a dynamic learning environment with excellent student-to-teacher interaction. More information: http://www.cfpie.com