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Challenges in Microbiology Validation: Current Practices and Future Trends

Report from the Validation in Analytical Sciences Workshop in Gent featuring experts discussing different validation approaches in microbiology fields such as food, water, and medical. Key topics include extent of validation needed, deviations from typical approaches, and challenges faced in validation processes. The workshop covered quantitative and qualitative methods, performance characteristics, international standards like ISO 13843, and challenges related to sample types and commercial aspects.

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Challenges in Microbiology Validation: Current Practices and Future Trends

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  1. WorkshopMethod Validation in Analytical SciencesCurrent practices and future challengesGent, 9-10 May 2016 Report from WG 3

  2. Validation in microbiology • Moderator: • Olivier Molinier, AGLAE Association, France

  3. Validation in microbiology • Participants • Turkan ABBASOVA : State Committee on Standardization, Metrology and Patent • Florence FERBER: ASBL REQUASUD • Elke PEETERS : Eurofins Food Testing Belgium • Guy LAMON : SGS Belgium NV • Leen DESMYTER: Inagro • Evelyne DEWULF: APB-DGO • Els KESTENS: BELAC • André MATHIEU : BELAC • Olivier MOLINIER : AGLAE • Bahar HOSSEINZADEH: Pasargad Quality Pioneers • Jörn PILON: AQUALAB Zuid • Dag GRøNNINGEN : NMKL • Ozge OZGEN ARUN: Istanbul University Veterinary Faculty

  4. Validation in microbiology • Different microbiology fields represented • Food / water / medical… • Accreditation bodies • Food institute • Consumer product safety • Consultancy • PT provider

  5. Questions • What are the different approaches applied in different fields? • How do you decide about the extent of validation needed? • Where does microbiology laboratories have to deviate from the “normal” approaches (e.g. like those recommended in the Eurachem “Fitness for Purpose” Guide)? • What are the documents available for guidance? • What are the challenges experienced in different areas?

  6. Questions • What are the different approaches applied in different fields?

  7. Questions • How do you decide about the extent of validation needed? • Distinction between validation (characterization) and verification: • Colony counts methods (quantitative) were discussed • Semi-quantitative (MPN methods) / qualitative method were only mentionned but not completely covered • qPCR / impedancemetry

  8. Questions • Where does microbiology laboratories have to deviate from the “normal” approaches (e.g. like those recommended in the Eurachem “Fitness for Purpose” Guide)? • In terms of : • Performance characteristics: • Lower limits (detection level / limit of determination) well defined based on statistical approach • Specific random variability (Poisson distribution) • Discussion about the log10 transformation of data

  9. Questions • What are the documents available for guidance? • International or national standards • ISO standards were used during the discussion : • ISO 13843 – ISO 16140-1 and 16140-2 • Other documents available • Eurachem MV Guide (second edition 2014) – Microbiology not sufficiently covered • Nordval / NMKL - Protocol for the validation of alternative microbiological methods

  10. Questions • What are the challenges experienced in different areas? • Samples used : Naturally contaminated samples/ spiked samples • Representativeness / cultivability • Determination of relative recovery • Use of PT samples / assigned value as a reference • Criteria definitions • Commercial aspects (cost / time consuming)

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