Recommendations for the content and management of Certificates of Analysis for reference standards from the GCC for bioanalysis

The 13th Global CRO Council (GCC) closed forum for bioanalysis was held in New Orleans, LA, USA on 5 April 2019. This GCC meeting was organized to discuss the contents of the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline published in February 2019 and consolidate the feedback of the GCC members. While ICH M10 will cover requirements for reference standards, one of the biggest challenges facing the CRO community is the lack of consistency and completeness of Certificates of Analysis for reference standards used in regulated bioanalysis. Similar challenges exist with critical reagents (e.g., capture and detection antibodies) used for assays supporting biologics. The recommendations provided in this publication are the minimum requirements for the content that GCC members believe should be included in Certificates of Analysis for reference standards obtained from commercial vendors, sponsors and compendial suppliers, for use in regulated bioanalytical studies. In addition, recommendations for internal standards, metabolites and critical reagents are discussed.

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GCC Consolidated Feedback to ICH on the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline

Bioanalysis ◽

10.4155/bio-2019-0207 ◽

2019 ◽

Vol 11 (18s) ◽

Cited By ~ 6

Author(s):

Corey Nehls ◽

Michael Buonarati ◽

Stephanie Cape ◽

Rafiq Islam ◽

Christina Satterwhite ◽

...

Keyword(s):

New Orleans ◽

Method Validation ◽

Draft Guideline ◽

Bioanalytical Method Validation ◽

Bioanalytical Method

The 13th GCC Closed Forum for Bioanalysis was held in New Orleans, Louisiana, USA on April 5th, 2019. This GCC meeting was organized to discuss the contents of the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline published in February 2019 and consolidate the feedback of the GCC members. In attendance were 63 senior-level participants from eight countries representing 44 bioanalytical CRO companies/sites. This event represented a unique opportunity for CRO bioanalytical experts to share their opinions and concerns regarding the ICH M10 Bioanalytical Method Validation Draft Guideline and to build unified comments to be provided to the ICH.

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Recommendations and Best Practices for Reference Standards and Reagents Used in Bioanalytical Method Validation

The AAPS Journal ◽

10.1208/s12248-014-9566-y ◽

2014 ◽

Vol 16 (2) ◽

pp. 352-356 ◽

Cited By ~ 10

Author(s):

Joseph F. Bower ◽

Jennifer B. McClung ◽

Carl Watson ◽

Takahiko Osumi ◽

Kátia Pastre

Keyword(s):

Best Practices ◽

Method Validation ◽

Reference Standards ◽

Bioanalytical Method Validation ◽

Bioanalytical Method

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European Bioanalysis Forum feedback on draft ICH M10 guideline on bioanalytical method validation during the Step 2b public consultation period

Bioanalysis ◽

10.4155/bio-2020-0065 ◽

2020 ◽

Vol 12 (6s) ◽

pp. 1-11

Author(s):

Philip Timmerman ◽

Joanne Goodman ◽

Michaela Golob ◽

Tobias Haslberger ◽

Magnus Knutsson ◽

...

Keyword(s):

Method Validation ◽

Public Consultation ◽

Future Generations ◽

Draft Guideline ◽

Bioanalytical Method Validation ◽

Efficient Manner ◽

Bioanalytical Method ◽

The Public ◽

Health Authorities ◽

History Of

Once released, the ICH M10 Guideline on bioanalytical method validation will become one of the most important milestones in the history of regulated bioanalysis, closing a chapter on intense discussions among the industry and health authorities started in Crystal City in 2001. In this manuscript, the European Bioanalysis Forum community reports back on their feedback on the ICH M10 draft guideline gathered during the public consultation period. The comments given are intended to contribute to a guideline that combines several decades of experience and current scientific vision. They should provide future generations of bioanalytical scientist a regulatory framework so their bioanalytical work can contribute to safe, effective and high-quality medicines, which can be developed and registered in the most resource-efficient manner.

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AAPS Workshop Report on ICH M10

The AAPS Journal ◽

10.1208/s12248-019-0398-7 ◽

2019 ◽

Vol 22 (1) ◽

Cited By ~ 2

Author(s):

Brian Booth ◽

Faye Vazvaei ◽

Eric Fluhler ◽

Heather Myler ◽

Eric Woolf

Keyword(s):

Method Validation ◽

Public Consultation ◽

Draft Guideline ◽

Bioanalytical Method Validation ◽

Efficient Manner ◽

Bioanalytical Method ◽

Technical Requirements ◽

Regulatory Guidelines ◽

Expert Working Group ◽

Key Aspects

AbstractOver the last decade, several regulatory guidelines on bioanalytical method validation (BMV) have been issued by regulatory agencies around the world. This has left the bioanalytical community struggling with regional differences in regulatory expectations when preparing for global pharmaceutical submissions. The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) has the mission to achieve greater harmonization worldwide to ensure that safe, effective, and high-quality medicines are developed and registered in the most resource-efficient manner. Following calls for harmonization, ICH-selected bioanalytical method validation and sample analysis among its topics for guidance development and earlier this year released a draft guideline (M10) on BMV for public consultation. In response, the American Association of Pharmaceutical Scientists (AAPS) held a 3-day workshop to provide a forum for regulatory, industry, and academic scientists to discuss the guideline and hear various points of view on key aspects. While there was agreement that the draft guideline is generally well written and comprehensive, specific topics generated considerable discussion and, in some cases, revision recommendations for consideration by the expert working group (EWG) responsible for the guideline content. This report provides a summary of the workshop proceedings.

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