Validation Workshop

Thursday, October 22nd

Workshop Agenda

(All of the workshop sessions will be available on the virtual conference platform on Thursday, October 22 at 11:00 a.m. EDT)

Welcome – Opening Statements

Klas Meyer (BAM) and John Edwards (Process NMR Associates, LLC)

ISO 17025 Requirements

Torsten Schönberger (BKA)

The Need for Proficiency Testing in the Scope of NMR Method Validation – A Role for the ValidNMR Organization?

In the scope of analytical method validation it is generally accepted, in the arena outside of NMR spectroscopy, that validation should include inter-laboratory comparison (ILC) studies or proficiency testing coordinated by a relevant third-party organization such as AOAC, AOCS, ASTM, ISO, USP, etc. Validated NMR methods that are in general use by the industrial community under the auspices of official organizations are very limited. The reasons for the lack of official NMR methods is often stated to be due to the high cost of NMR instrumentation and the fact that it resides in research centers rather than in manufacturing plant laboratories. Over the years, chromatography has been preferred in these environments even though it requires constant calibration with expensive standards. As a primary method NMR does not require continued calibration with standards and appropriate utilization of superconducting and benchtop systems to provide ID and qNMR in purity, potency, and complex mixture analysis could greatly reduce the burden on chromatography approaches. A short review of the limited number of NMR-based inter-laboratory comparisons will be presented to provide a background to this topic. Further discussion will elaborate on the role that the ValidNMR organization could play as an interface between standard method development in industry and the requirement to determine intra-lab and inter-lab error and bias through ILC studies or third-party coordinated proficiency testing.

John Edwards (Process NMR Associates, LLC)

BAM Quality Toolbox Framework for qNMR

Accreditation of analytical methods, either according to GxP or ISO regulations, requires a comprehensive quality management system. General quality documents are often already in place, which need to be extended by method-specific documentation. In this presentation we like to show an idea of a modular set of standard operating procedures (SOP) specifically developed meeting the requirements for quantitative NMR. The future goal is to collaborate with different accreditated NMR laboratories to compile a universal set of SOP and other quality documents that can be modified and used as a starting point for developing your own quality system for applications of qNMR in a regulated environment.

Klas Meyer (BAM)

NMR Validation as Per ICH Guidelines

More than a quarter century ago, the International Conference on Harmonization (ICH) introduced the first guidance on analytical method validations (Q2). These guidelines focused primarily on chromatographic methods. In the interim more analytical technologies, including NMR, have become commonplace, necessitating guidelines for validating methods which use these techniques.  This talk will focus on the different validation characteristics, with examples from my NMR lab, and briefly discuss the upcoming revision of Q2 and introduction of Q14 (Analytical Procedure Development).  

Cathy D. Moore (Element Materials Technology)​


Remote Audits

Remote audits have gained much importance during the COVID-19 pandemic. Only companies which has been inspected in the past and showed a good GMP compliance are suitable for a remote audit, also known as distant assessment. Remote audits can be performed in various ways, so each company has to find its individual way. Several questions should be asked and answered: security and privacy policies, time (time zones!), number of audit days, scope and procedure such as agenda and audit team,  access (platform) and review of documents, technical environment and virtual tour. The scope of the presentation is not to give you answers, but to give you an impression about the questions you have to find answers for.

Elina Hafer (Spectral Services)


Validation of qNMR Analytical Procedure by Using Certified Reference Materials and Inter-Laboratory Comparison

Quantitative nuclear magnetic resonance is a powerful tool in quantitative determination of the main component and impurities in a drug substance or a drug product because of its high accuracy, precision and efficiency. This method has the potential to establish metrological traceability easily and expected to be widely utilized for some compendial guidelines and official standards. Here, we conducted an inter-laboratory comparison for qNMR methodology and confirmed that statistically qNMR has the competence to obtain the same quantification performance and accuracy as the conventional reliable methods.

Toru Miura (FUJIFILM Wako Pure Chemical Corp)

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