Continuous Manufacturing: The FDA’s Pet Project
In February of this year, the FDA released new draft guidelines on Quality Considerations for Continuous Manufacturing, an area the agency has shown increasing interest in, despite the fact that only 20 pharmaceutical manufacturers in this country are currently invested in continuous manufacturing or are considering it as an option for their business.
However, the release of the report indicates the FDA’s interest in this process as a win for good manufacturing practices. Pharmaceutical professionals seeking GMP certification would be well-advised to be aware of trends in this area, as the FDA advises that continuous manufacturing not only decreases the risk of drug shortages, but also improves consistency, leading to a better product.
Major manufacturers have concerns of their own with the FDA’s report, which they critiqued as incomplete in some areas. For example, the draft guidelines are explicitly geared towards the manufacture of oral drugs with no recommendations for biologics.
Of particular interest to professionals with GMP certification, the FDA also suggest in their guidelines that implementing continuous manufacturing result in a decreased need for postapproval submissions to the agency, as manufacturers would be engaged in more robust quality systems analysis. However, they did not specifically address which submissions could be removed from the process, leading to confusion and questions from manufacturers.
These debates on the usefulness of continuous manufacturing are one reason why ensuring that your GMP certification is up-to-date is important, to keep you competitive in the job market. Our cGMP certification course keeps you current, and our instructors not only discuss the industry standards of today, but open up discussion to the issues that will affect GMP certification in the future. We encourage all participants to prepare questions and engage with their peers in the course to gain a robust understanding of issues in this ever-changing field.
To register, visit the course page or call 1-610-648-7550.
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