SPI Publishes Updated Guide to Regulatory Considerations for Drug Packaging Materials

The guide is designed to provide information useful to the entire pharmaceutical supply chain.

SPI: The Plastics Industry Trade Association is pleased to announce the publication of an update to its 2003 Guidelines for the Development of Type III Drug Master Files.  This manual, prepared by the SPI Pharmaceutical and Medical Device Applications Committee, is a guide to the regulatory considerations and procedures to be taken into account when establishing a Type III Drug Master File.  The new updates reflect procedural changes at the U.S. Food and Drug Administration and "best practices" amassed by the law firm of Keller and Heckman.

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