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and Leachables for Pharmaceutical Products

This book specifically addresses the safety aspects of compatibility for drugs and their delivery devices and containers. The author deals with issues such as how the leachables impact safety of a therapeutic product and, more importantly, how one ascertains the magnitude of the impact. The book examines the strategies and tactics for performing safety assessments for leachables and extractables and establishes the means for interpreting the results obtained from such assessments. It helps the pharmaceutical industry unify methodology for assessing leachables and extractables safety of drug packaging.

From the Back Cover Compatibility of Pharmaceutical Products and Contact Materials

Dennis Jenke

Important safety aspects of compatibility for therapeutic products and their manufacturing systems, delivery devices, and containers

Compatibility of Pharmaceutical Products and Contact Materials helps pharmaceutical, toxicology, analytical, and regulatory affairs professionals assess the safety of leachable and extractable chemicals associated with drug product packaging, manufacturing systems, and devices. The most comprehensive resource available, its coverage includes the strategies, tactics, and regulatory requirements for performing safety assessments, along with the means for interpreting results.

Structured around a logical framework for an extractables and leachables safety assessment and closely linked to the pharmaceutical product development process, Compatibility of Pharmaceutical Products and Contact Materials directly addresses the fundamental questions of "what activities need to be performed to completely, efficiently, and effectively address the issue of product safety from an extractables and leachables perspective?" and "when do the various required activities need to be performed?" Specifically, the chapters describe:

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* Pertinent regulations and practical ways to meet guidelines

* Coordinating manufacturing, storage, and delivery systems development and qualification with therapeutic product development

* Materials characterization and the materials screening process

* Component and/or system qualification (illustrated by several case studies)

* Performing validation/migration studies and interpreting and reporting the results

* Creating a product registration dossier and putting it through regulatory review

* Product maintenance (Change Control) from an extractables and leachables perspective

* Likely future developments in extractables and leachables assessment

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