[Author’s Note: Part I covered the history and background of the USDA’s Animal and Plant Health Inspection Services (APHIS)/Center for Veterinary Biologics (CVB), what the agency regulates and how, number of sites, products, and species regulated, and how it supports the health of the U.S. herd from a presentation by USDA CVB Senior Biologics Specialist Kendall Graber at the International GMP Conference held virtually in March 2021. Part II provides a comparison of GMPs in 21 CFR and requirements in 9 CFR—the similarities, and differences—and CVB’s compliance program.]
“Why aren’t current Good Manufacturing Practices (CGMPs) such as 21 CFR used to regulate veterinary biologic products?” Graber asked. Within the U.S., the federal Food, Drug, and Cosmetic Act, which is specific to human and veterinary drugs—not biologics—has the requirements for CGMP.
[Related: Redica Systems includes information on U.S. FDA CVM inspections. Try our platform our for free.]
The Virus-Serum-Toxin Act, which is specific to veterinary biologics, is codified in 9 CFR. “There is a long history of quality manufacturing requirements and regulations within the United States,” he explained. “Not all GMPs are created equal. There are variations from country to country. 9 CFR is a performance-based, process-controlled, regulatory system, which is recognized worldwide for export.”
9 CFR and GMPs have similar quality manufacturing and testing standards, he said, and they share a common goal, as both are intended to ensure consistency of production and testing and provide for pure, safe, potent, and effective biologics for consumers.
In addition to CFR 9, CVB publishes on policy and guidance through documents such as Veterinary Services Memorandum, and on practice through documents such as Veterinary Biologics Notices, supplemental assay methods, licensing guidelines, and its inspection and compliance manual, which is located on the APHIS website.
Not all GMPs are created equal. There are variations from country to country
One of the areas where 9 CFR and GMP appear to vary on paper is quality management. 9 CFR does not specifically define requirements for a quality unit or internal audits. However, product quality is a requirement, and CVB has found that many regulated manufacturers utilize quality management systems and self-inspection programs as a mechanism to ensure compliance to the requirements of 9 CFR.
9 CFR does not spell out specific validation requirements. However, there are in-process control requirements to ensure validity of testing. In-process validation is valuable as finished product testing moves away from in vivo testing and historical assays to other methods to evaluate purity, safety, potency, and efficacy parameters.
“While quality management and validation are not defined as requirements by 9 CFR,” Graber said, “compliance with other requirements of 9 CFR demonstrate that they are in place. There are, in fact, many parallels between 9 CFR and CGMP (Figure 1).
CVB’s Compliance Program
Graber explained that in addition to the inspections CVB performs, “compliance is assured by numerous factors,” including test results and other reviews and monitoring (Figure 2).
[Author’s Note: Part III will provide an in-depth look at USDA’s expectations and discussion on key CFR section.]
[Related: Redica Systems includes information on U.S. FDA CVM inspections. Try our platform our for free.]
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