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Speaker from Authority
DR CORINA NACHTSHEIM, Quality Assessor, Germany
DR USFEYA A. MUAZZAM, Bonn, Germany
DR GISELA FONTAINE, Solvias AG, Switzerland
DR THOMAS HÄMMERLE, Baxter AG, Austria
DR GERD JILGE, Boehringer Ingelheim Pharma GmbH & Co. KG, Germany
DR HEIKE SCHMIDT-EISENLOHR, LPU Labor für Pharma- und Umweltanalytik GmbH, Germany
DR XAVER SCHRATT, LPU Labor für Pharma- und Umweltanalytik GmbH, Germany
DR LANCE SMALLSHAW, UCB Biopharma sprl, Belgium
DR ANDREW TEASDALE, Astrazeneca, United Kingdom
DR ANDREAS WOLF, AbbVie, Germany
In Part II of the Impurities Forum the key principles of the new ICH Q3D Guideline will be highlighted. You will get to know the essential aspects and approaches of determining and controlling elemental impurities in drug products.
You will learn
which are the principles of the elemental impurities risk assessment process,
how to implement risk-based strategies to control elemental impurities,
which analytical methods are suitable to determine
elemental impurities and what you have to consider when you apply them,
what you need in your QC lab to be prepared for elemental impurities analytics.
In November 2014 the ICH Q3D Guideline for Elemental Impurities was published as Step 4 document. This document outlines
the evaluation of the toxicity data for potential elemental impurities
the PDEs for each element of toxicological concern
the development of controls designed to limit the inclusion of elemental impurities in drug products to levels at or below the PDE
In March 2015 USP announced a revision to General Notices section 5.60.30 Elemental Impurities in USP Drug Products and Dietary Supplements, establishing 1 January 2018 as the new date of applicability of General Chapters <232> Elemental Impurities-Limits and <2232> Elemental Contaminants in Dietary Supplements. The limits provided in GC <232> align with ICH Q3D Step 4. GCs <232> and <233> Elemental Impurities-Procedures will become official on 1 December 2015.
Also in March 2015 the European Pharmacopoeia decided to delete the reference to the test for heavy metals (2.4.8) from all individual monographs on substances for pharmaceutical use.
The conference addresses all personnel involved in development of drug substances and drug products from scientific staff to laboratory heads involved in R&D. The needs of Laboratory Managers, Supervisors and Analysts in pharmaceutical quality assurance and quality control departments will also be covered.
The new ICH Q3D Guidance on Elemental Impurities – authorities expectations
Scope and applicability of the ICH Q3D guideline
Similarities and differences with the EU-Metal Catalysts guideline
What is the link with the EP and USP monographs?
The classification system of heavy metals and metal catalysts in the proposed guideline, thresholds.
Implications to the API industry – additional requirements – analytical work required – costs
What do authorities expect?
Utilisation of Data as part of an Integrated EI Risk Assessment Process - Role of Industry Collaboration /FDA-IPEC Excipient Study Data
An overview - Utilisation of Data as part of an Integrated EI Risk Assessment Process
Practical Implementation Considerations
Potential Sources of Elemental Impurities in the Finished Product
- Container-closure system
Data sharing - Elemental Impurities Pharma Consortium – current status – future aims
Safety assessment of metallic impurities in oral dosage forms – limits and
Permitted Daily Exposure (PDE)
General principles of safety assessment
How to determine PDEs
Conversion between PDEs and concentration limits
Justification for impurity levels higher than the PDE
Analytical methods to determine metallic impurities
Principles and characteristics of the most common spectrometric techniques AAS, ICP-OES, ICP-MS
Compound methods (sample preparation plus spectrometric detection and
Special considerations for trace-elemental analysis
Application-based approach for choice of methodology
Analytical process (method development, validation strategy, routine testing)
QC lab infrastructure and equipment for metal impurities analytics
Process-oriented laboratory design
Basic components of a trace elemental laboratory
Approaches for contamination control
Handling of highly active pharmaceutical compounds in a trace elemental laboratory: operator protection versus product protection?
Accessories for interference control in ICP-MS
Identification and assessment of potential elemental impurities in pharmaceutical excipients
Potential sources of elemental impurities in pharmaceutical excipients
Important aspects of excipients safety assessment
Excipients supplier qualification
Classification of elemental impurities: examples
An approach to risk assessing for elemental/metallic impurities
ICHQ3D - what’s expected
An example of a Risk Tool Macro
What information is required for Skip Testing – Ph.Eur./ICHQ3D expectations
Regulatory filing – Where do I include information relating to a Risk Assessment