Navigating grades and sources of materials in drug manufacturing

May 31, 2024

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In drug manufacturing, understanding material quality—from raw materials to finished dosage forms (FDF)—is crucial. Complex global supply chains, inconsistent standards, and practical challenges in ensuring material suitability make sourcing and quality control difficult. The article by Allison Radwick highlights the importance of material grades and sources for safety and functionality, emphasizing their role in supply chain integrity and patient protection.

Excipients, though inactive, play a vital role in drug formulations, influencing stability and bioavailability. Regulations mandate drug quality, but there is often uncertainty around material selection, leading to potential risks from using inappropriate suppliers. The U.S. Pharmacopeia (USP) sets standards for material suitability, including identity, strength, purity, and performance, guiding manufacturers in selecting appropriate materials for drug production.

Global regulations on pharmaceutical material standards vary, but most countries rely on pharmacopeial standards. The USP’s guidelines ensure materials meet high benchmarks, including GMP compliance. Multi-compendial grades simplify international trade, but materials lacking specific standards require stringent quality checks.

Supplier qualification is essential to mitigate risks of material quality and safety. Economically motivated adulteration and inconsistencies in GMP-grade materials necessitate robust verification beyond certificates of analysis (COAs). Organizations like IPEC-Americas and USP provide guidance on best practices for supplier qualification, emphasizing auditing, risk assessment, and change management.

Ensuring material quality is vital for patient health. Manufacturers must adopt rigorous selection protocols, GMP adherence, traceability, testing programs, and supplier qualifications to secure the supply chain and safeguard patients. Unified standards and cooperation can enhance supply chain security and resilience.