Pharmaceutical Packaging - Regulations and Testing Standards

Why Should You Attend:

An often overlooked aspect of pharmaceutical development and supply chain maintenance is the interplay between pharmaceutical dosage forms and their respective packaging. Along with control on the ingredients, both active and excipients, proper control of packaging is crucial to both developing an effective product and maintaining proper purity, efficacy and safety over the intended shelf-life. With the 2006 publication of the Product Quality Research Institute’s Safety Thresholds and Best Practices for Leachable and Extractables in Orally Inhaled and Nasal Drug Products (OINDP)[1], the design and safety expectations for packaging compatibility studies was put on a sound scientific basis. Worldwide regulatory authorities now expect that similar scientific justifications be constructed for all dosage forms. This expectation has expanded in recent years to include any surface, even during processing, to be investigated and justified.

This webinar will begin with a discussion of the history behind the legal basis of pharmaceutical regulations in the US and EU. Recent regulatory trends with regards to packaging will also be discussed.

Learning Objectives:

Upon completing this course, participants should understand:

• The historical basis and legal process of US regulations
• Key on-line resources for regulatory expectations for pharmaceutical packaging
• How to build effective testing strategies by marketing region
• How to build effective testing strategies by submission type
• The difference between acceptable and unacceptable changes due to packaging
• How to evaluate extractables separately from leachables
• How to construct threshold justifications by dosage form or surface

Areas Covered in the Webinar:

• History behind the legal basis of pharmaceutical regulations in the US and EU
• Categorization of packaging risk by marketing region
• Identification of pertinent regulatory documents
• Examples from initial marketing authorizations
• Change management strategies
• Preparing and evaluating requests for proposals
• Recommendations for submission documentation

Who Will Benefit:

This course is designed for pharmaceutical professionals tasked with developing or controlling pharmaceutical packaging systems including those who have no prior experience. Key organizational roles may include QC, Regulatory or Quality Management Systems responsibilities such as:

• Regulatory professionals
• Compliance professionals
• Quality auditors
• Quality control supervisors
• Analytical development professionals

Thomas Feinberg
President, SCIO Analytical LLC

Thomas N. Feinberg, Ph.D., President, SCĪO Analytical, LLC - He founded SCIO Analytical in 2014 as a science-based consulting resource focused on helping clients find solutions for difficult analytical chemistry problems such as extractables and leachables. Prior to SCIO Analytical, Dr. Feinberg worked for four years at the University of North Carolina at Chapel Hill in Chemistry and Environmental Sciences followed by a two-decade career at the Morrisville, North Carolina site of Catalent Pharma Solutions (formerly Cardinal Health and Magellan Laboratories). As the first LC-MS chemist at Magellan, he grew the Structural Chemistry function to become the industry leader in CMC support laboratory services impurity and degradant investigations and developed one of the premier laboratories for extractables and leachables studies across all dosage forms. Dr. Feinberg is internationally recognized, serving as an active member of the Product Quality Research Institute (PQRI) since 2001 and as the trainer for the 2006 PQRI Orally Inhaled and Nasal Drug Product Extractables and Leachables process. He has been a science advisor to the Materials Working Group of the International Pharmaceutical Aerosol Consortium on Regulations and Science (IPAC-RS) since 2012. At SCIO Analytical, Dr. Feinberg has assisted clients with designing and remediating quality control and assurance systems for drug substances, drug products, containers and novel manufacturing processes. He has worked with clients on successful regulatory filings across all phases of development. Dr. Feinberg completed his bachelor’s degree in Chemistry at Cornell University and his doctorate in Physical Chemistry at the University of North Carolina at Chapel Hill.

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