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Quality Elements for Suppliers of Products or Services to GMP Regulated Companies

Medical products are items used to diagnose, treat, cure, mitigate or prevent disease in patients. These include pharmaceutical products and medical devices. The manufacture of medical products that are used in the United States, and in many other countries, are regulated by Good Manufacturing Practices (GMP) and Quality System Regulations (QSR). These regulations, which are nearly identical in many countries, cover not only the manufacture of finished products, but may also encompass starting and intermediate materials and related services that are a part of the supply chain for those medical products. The result is that many medical product manufacturers require products or services from providers who adhere to GMP/QSR (collectively, “GMP”) as well. Adoption of GMP can provide advantages to suppliers, including expanded market opportunities with the added benefit of increased profitability through improved manufacturing techniques.

The purpose of this document is to outline those basic GMP elements that may be required of suppliers whose products or services eventually enter the supply chain for the manufacture and delivery of regulated medical products. When established and followed, these GMP elements help to assure product quality, minimize compliance risk to the manufacturer, and protect patients. This document addresses the risks involved regarding the intended use vs. actual use of products and services.