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.
“Pharmaceutical and medical device manufacturers may want to share this publication with their suppliers,” said Patty Long, SPI’s Director, Industry Affairs. “The regulatory considerations that go into the packaging materials for these products are important information for both ends of the supply chain -- from the brand owner to the processor.”
By necessity, and for the common good, the pharmaceutical industry is closely regulated. Suppliers to the pharmaceutical industry should be knowledgeable about the regulatory requirements to which the industry and their customers are subject. The main purpose of this manual is:
1) To provide general information on the regulatory scheme applicable to packaging materials for new drugs,
2) To provide information on how to prepare a Drug Master File (DMF) for materials used in drug packaging applications,
3) To explain those regulatory considerations that limit the ability of drug manufacturers to change suppliers of their packaging materials and of packaging manufacturers to alter the materials or manufacturing processes used in the production of their products, and
4) To provide practical advice on maintaining, transferring, and closing DMFs
“Guidelines for the Development of Type III Drug Master Files” is available free-of-charge and may be downloaded here .