Speakers from Authority & United States Pharmacopeia
Dr Ulrich Rose, EDQM, France
Dr Kahkashan Zaidi, USP, USA
Dr Gerd Jilge, Boehringer Ingelheim Pharma, Germany
Dr Samuel Powell, Pfizer, UK
Dr Xaver Schratt, LPU GmbH, Germany
Dr Andrew Teasdale, AstraZeneca, UK
Dr Lise Vanderkelen, Toxicon Europe, Belgium
In Part II of the Impurities Forum the key principles of the ICH Q3D Guideline on elemental impurities will be highlighted. You will get to know the essential aspects and approaches of how to determine and control elemental impurities in drug substances, drug products and excipients. You will learn
- what has to be considered with respect to the drug substance monographs of the European Pharmacopoeia
- how to perform a risk assessment in order to establish a control strategy for elemental impurities,
- how the route of administration and the duration of exposure affect the limits of elemental impurities
- which analytical methods are suitable to determine elemental impurities and what you have to consider when you apply them,
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 basis for an EI risk assessment and the key factors for evaluation.
- the development of controls designed to limit the inclusion of elemental impurities in drug products to levels at or below the PDE
In the European Pharmacopoeia the test for heavy metals (2.4.8) from approx. 760 individual monographs on substances for pharmaceutical use (except substances for veterinary use only) were deleted. The revised versions of the general monographs on Substances for pharmaceutical use (2034) and Pharmaceutical preparations (2619), of the general chapters on Elemental Impurities (5.20) and on Determination of elemental impurities (2.4.20) have been adopted and will become effective on 1 January 2018.
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 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.
EDQM’s implementation strategy of ICH Q3D in the European Pharmacopoeia – an update
ICH Q3D on elemental impurities – requirements and implementation status in the USP general chapters and monographs
Analytical methods to determine elemental impurities
- History of heavy metals tests
- Implementation strategy of ICH Q3D in Ph. Eur.
- Modifications of general chapters and general monographs
- Specific metal tests in individual monographs
Control Strategies for Elemental Impurities in final dosage forms – Case studies
- Principles and characteristics of the most common spectrometric techniques AAS, ICP-OES, ICP-MS
- Compound methods (sample preparation plus spectrometric detection and quantification)
- Special considerations for trace-elemental analysis
- Application-based approach for choice of methodology
- Analytical process (method development, validation strategy, routine testing)
- Utilisation of Data as part of an Integrated EI Risk Assessment Process
- Potential Sources of Elemental Impurities in the Finished Product: API, Equipment, Container closure system, Excipients
Conducting a risk assessment
In this Workshop the participants will work on several case studies and perform a risk assessment for different scenarios taking into account e.g. manufacturing equipment, dosage form of the drug product etc.