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Lhasa Limited: Enabling ICH compliance through our products

Date: 08 August 2018

Lhasa

The International Conference on Harmonisation (ICH) brings together regulatory bodies from the pharmaceutical industry to discuss aspects of drug registration. Its mission is to achieve greater regulatory alignment to ensure that safe, effective, and high-quality medicines are developed and registered in the most resource-efficient manner. This is realised through the development of ICH Guidelines.1 

The ICH M7 guideline, which relates to the assessment and control of mutagenic impurities, has now been implemented in Europe, US, Canada and Japan2,3,4,5. Lhasa is proud to be able to support its members as they make ICH M7 submissions in a variety of ways, including by providing trusted software, databases, and scientific support. 

The ICH M7 framework below shows how Lhasa products align with the key steps of an ICH M7 workflow.

  • - For example, Zeneth can be used to identify potential degradants that may be present as impurities.
  • - The Lhasa Carcinogenicity and Vitic databases provide expert-curated collections of carcinogenicity and bacterial mutagenicity data and data sharing groups extend this with additional non-public data.
  • Derek Nexus and Sarah Nexus, developed in collaboration with industry and regulators, provide the mutagenicity predictions required under ICH M7 and, when used together within the Nexus platform, can even assign a classification to each impurity.
  • - Finally, in order to assess whether the predicted impurities will be present in the final product, Mirabilis uses an industry-standardized approach to calculate purge factors based on referenced, scientific knowledge. In this way, Mirabilis can be used to satisfy ICH M7 Control Option 4 and hence may reduce the need for costly and time-consuming analytical tests.

 

  This paper, written by Lhasa CEO Chris Barber et al., introduces the Mirabilis consortium, and discusses the advantages which exist when Mirabilis is implemented for purge factor calculations.  

 

In light of the wide adoption of ICH M7 (R1), this article discusses some of the ways Lhasa can support you with other international guidelines.

For example, the Vitic Acceptable Intake (AI) and Permitted Daily Exposure (PDE) data sharing consortium, which was initiated in 2017, shares and harmonises data on AI/PDEs through a peer review process. Calculation of AI/PDEs is required under multiple ICH guidelines (M7, Q3A, Q3B and Q3C) and this calculation can be time-consuming and costly. By harmonising and sharing this data, the AI/PDE consortium reduces duplication across industry and also reduces the probability of submissions to regulators being non-equivalent. Having access to this shared data saves time and money and also reduces the chance of a non-standard calculation being rejected.
 

 

Find out more about the AI/PDE consortium in this webinar.

 

The ICH Q3D Guideline for Elemental Impurities presents a process to assess and control elemental impurities in final drug products6. Elemental impurities may find their way into drug products from several sources, one of which is as impurities in the excipients used in the drug formulation. 

The Vitic Elemental Impurities data sharing consortium was established to support the sharing of analytical data on the levels of trace elements measured in batches of pharmaceutical excipients. This has resulted in a high-quality, curated database containing information on the levels of elemental impurities in common excipients. This continually-expanding database provides you with access to proprietary data which can support the practical implementation of the ICH Q3D guideline
  For more information, this recent publication in the Journal of Pharmaceutical Sciences describes the Elemental Impurities database and an analysis showing the coverage in terms of real-world drug product formulations.

 

Lhasa is an educational charity and invests in providing quality scientific publications and conference presentations which are supplemented by guidance documents and face-to-face and web-based training. These are all available on our website, providing a valuable resource to our members.

Lhasa strives to provide excellent solutions for our members, working alongside regulators and across industry to collaborate for the benefit of all. Lhasa has good relationships with regulatory agencies around the world, and our software has been accepted in a variety of regulatory submissions, including for ICH M7. Lhasa’s software and databases are collaboratively developed with users to fit their workflows and allow the user to make confident and supported decisions.

To find out more about how Lhasa may be able to help you with your science, please get in touch.

 

References
  1. ICH Mission
  2. Notice of adoption of ICH M7, FDA 
  3. Document History for ICH M7, EMA
  4. Notice of adoption of ICH M7, Health Canada
  5. ICH Multidisciplinary Guidelines
  6. ICH Q3D Current Step 4 version dated 16th December 2014 
  • Summary:

    In light of the wide adoption of ICH M7 (R1), this article discusses some of the ways Lhasa can support you with other international guidelines.

  • Categories:
    • Zeneth
    • Sarah Nexus
    • Vitic
    • Products
    • Mirabilis
    • Derek Nexus
    • Collaborative Projects

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