Understanding and Implementing the New ICH/USP Elemental Impurity Guidelines

Instructor: Barrett Rabinow
Product ID: 704984
  • Duration: 90 Min
In this webinar you will learn the different global regulatory agencies’ expectations for meeting the new ICH/USP elemental impurity guidelines. Different strategies for compliance will be presented with numerous illustrative examples.

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Last Recorded Date: Dec-2017

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Why Should You Attend:

Mandatory ICH Q3D/USP testing for elemental impurities (EI) in current, finished drug products becomes law on January 1, 2018. In both Europe and the US, the EQDM/EMA and FDA deadlines for compliance of new marketing authorization and new drug applications, respectively, with ICH Q3D became effective June 2016. Implementation requires extensive prior work.

Implementation imposes considerable new requirements upon the company pharmaceutical quality system. These include: drug product specification table (test, method(s), limits); non-compendial test method(s), relevant reference standards used, and validation package; GMP related processes to limit the inclusion of EI, change management processes (triggers for updates); periodic review; original data used in the product assessments, quality agreements, supplier qualification, etc.

This webinar will cover the FDA , USP and ICH Q3D requirements for elemental impurities. It will further provide the understanding of the design of studies required for manufacturers to comply.

Areas Covered in the Webinar:

  • Introduction to Elemental Impurities (EI) and EI Limits
  • USP, FDA and ICH Timeline for Implementation
  • Implementation Strategy Scenarios
  • FDA Documentation Expectations (Documents Required of Quality to Comply)
  • Requirements for Analytical Instrumental Methods to Comply with ICH Q3D
  • Understanding of the Depth and Design of Studies Required of Manufacturing to Comply
  • Approaches for Elemental Impurity Evaluation
  • Analysis of Typical EI Levels in Container Materials and Excipients
  • CRO Evaluations
  • Troubleshooting EI Issues in Manufacturing

Who Will Benefit:

  • Senior quality managers
  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Production managers
  • Manufacturing engineers
  • Production engineers
  • Design engineers and managers
  • Process owners
  • Quality engineers
  • Quality auditors
  • Document control specialists
Instructor Profile:
Barrett Rabinow

Barrett Rabinow
Baxter Distinguished Scientist, Baxter Healthcare

Barrett Rabinow was previously a Baxter Distinguished Scientist at Baxter Healthcare Corporation where he worked for over 39 years. He received his A.B. from Cornell University in 1968 and a Ph.D. in Chemistry in 1974 from the University of Chicago. From 1975-1976, he completed postdoctoral fellowships in electrochemistry, and in clinical chemistry at Michael Reese Hospital, Chicago. From 1976-1977, he served as Director, Clinical Chemistry Laboratory, Norwegian-American Hospital in Chicago. He then joined Baxter Healthcare Corporation in 1977. His positions of increasing responsibility led to the position of Director, Chemistry, where he oversaw chemistry, particle science, material science, polymer technology, and manufacturing troubleshooting for the parenterals solutions business. Dr. Rabinow has been active in industry task forces, organized by the Parenteral Drug Association, AdvaMed, Association for the Advancement of Medical Instrumentation, and the International Standards Organization as well as collaborative studies with USP, FDA, and NIH. For six years, he identified and evaluated new business opportunities, leading to Baxter acquisitions. He has developed lifecycle reformulations of drugs with new pharmacological characteristics in the area of nanosuspensions and stereoisomers. He led a team developing innovative lean stability testing protocols for parenteral solutions. Dr. Rabinow has numerous patents to his credit in the area of pharmaceutical formulations, nanoformulations, and biomaterials. He has authored four book chapters and over 40 articles, in the areas of physical-organic chemistry, clinical and analytical chemistry, trace metals, biomaterials, packaging, pharmaceutical science, drug delivery, pharmacokinetics, pharmacology and drug targeting.

Topic Background:

The new EI limits require more sophisticated analytical technology, such as ICP-MS, not routinely used in QC labs. The ultra-sensitive analytical method must be validated specifically for all of your different dosage forms. Additionally, a risk managed approach is required to understand the contributions from your entire manufacturing process to 27 different designated trace elements of concern. Each EI has different limits, which vary depending upon the dosing volume of each different dosage form. Implementation requires considerable additional resources including capital expenditure for instrumentation in each plant and back-up with highly trained analysts (and back-up).

Practical implementation of ICH Q3D establishes a risk based approach. The fundamental challenge, however, is to find a means to categorize risk. This means an exhaustive assessment of all the components of manufacturing including API, excipients, water, manufacturing equipment, processing aids, and container closure system to determine their contributions to all 27 EI. Alternatively, it is possible to simply do final product testing on finished dosage forms. This carries the risk, however, that failure here involves discarding the batch.

Regulatory dossiers for all products must be updated to include: an updated drug product specification table (test, method(s), limits); non-compendial test method(s), relevant reference standards used, and validation package; summary of identified EI and observed or projected levels; data from representative commercial batches (component or drug product dependent upon the approach taken); summary of product risk assessment (discussing risks and controls); Conclusion of the product assessment, demonstrating compliance with established Permissible Daily Exposures (PDE) of identified EI; post-approval stability protocols if updated for EI testing.

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