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Supply Chain Reliability and Security

September 16, 2014

In the face of challenging regulatory pathways, complex technologies, and scrutiny of raw materials, manufacturers of combination products want to be particularly diligent about supply chain security and reliability.

In the United States, a key step to ensuring a reliable supply chain is to look for a supplier that follows the FDA’s Current Good Manufacturing Practices (cGMPs), which are detailed in the Code of Federal Regulations 21 CFR 820 for devices and 21 CFR 210/211 for drugs. These technically apply only to the combination product’s manufacturer. Choosing a supplier very familiar with and actively practicing the critical components of cGMPs, however, can offer assurance that the component or material meets key quality system requirements. The FDA does, on the other hand, require that a manufacturer oversees its suppliers and ensures that they have adequate quality management processes in place. This is spelled out in the Code of Federal Regulations Title 21: Section 820:50 (Purchasing Control): “Each manufacturer shall establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements.”

Similar statements can be found in other FDA regulations. For example, FDA’s “Guidance for Industry Q10: Pharmaceutical Quality Systems” requires pharmaceutical companies to manage outsourced activities and purchased materials, including making sure they comply with appropriate GMPs. Additional details on cGMPs for finished pharmaceuticals, specifically pertaining to the control of components and drug product containers and closures, can be found in 21 CFR 211.84.

While FDA’s GMPs apply to companies with products in interstate commerce in the United States, the term GMP is not only a U.S. concept. The European Union, Canada, and even the World Health Organization, for example, have established their own GMP standards as well. In addition, international organizations such as the International Conference on Harmonization and the International Medical Device Regulators Forum have established GMP guidelines for active pharmaceutical ingredients and medical devices in the form of ISO 14969 and ISO 13485 GMPs for Medical Devices.8 These guidelines are being adopted as regulations by some countries.

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