Too often, I see folks in pharma focus on 21 CFR Chapter 1, or at best all three chapters, maybe know the guidances and pay attention to little else. Unfortunately, that approach will often get one in trouble.
Section 711 of the Food and Drug Administration Safety and Innovation Act (FDASIA) amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to enhance the safety and quality of the drug supply chain. Specifically Section 711 amends Section 501(a)(2)(B) of the FD&C Act by adding the following sentence:
“For purposes of paragraph (a)(2)(B), the term ‘current good manufacturing practice’ includes the implementation of oversight and controls over the manufacture of drugs to ensure quality, including managing the risk of and establishing the safety of raw materials, materials used in the manufacturing of drugs, and finished drug products.”
This amendment clarifies that current good manufacturing practice (CGMP) requirements for drugs include:
- Implementing oversight and controls over the entire manufacturing process to ensure quality.
- Managing the risks related to raw materials, other materials used in manufacturing, and finished drug products to establish their safety.
In essence, Section 711 expands the FDA’s CGMP authority to explicitly cover supply chain management and drug manufacturers’ oversight of their suppliers and contract manufacturing operations. It also allows the FDA to enforce supply chain control requirements during inspections.
The legislative history shows that Congress intended to significantly expand the FDA’s authority over the increasingly global drug supply chain through this provision. It allows the FDA to scrutinize how manufacturers select, qualify, and oversee suppliers of raw materials and contract manufacturers to ensure drug quality and safety.
Please note that the FDA gets this expanded authority without revising 21CFR. That’s how it works; Congress can do that. Will we eventually see some 21 CFR updates? I have no idea.
But what this does mean is that the FDA has the authority to:
- Inspect risk management for GMPs, and assume you have it. What does good risk management look like? The agency has adopted ICH Q9(r1) as guidance, so start there.
- Inspect your supplier management, which includes qualifying and overseeing suppliers and contract manufacturers.
I’ve started to receive regulatory intelligence that this is coming up in inspections. Expect to be asked for the risk management evidence and for supplier qualification and oversight evidence.
Investigations of a Dog 