Quality Management System and Standardization for. Biobanks and bioresources ISO/TC 276

Transcription

1 Quality Management System and Standardization for Biobanks and bioresources ISO/TC 276 Lily Eurwilaichitr, Ph.D. Thailand Bioresource Research Center (TBRC), National Center for Genetic Engineering and Biotechnology (BIOTEC), NSTDA, Thailand 1

2 Biobank A foundation of the biotechnology infrastructure Critical to the assurance of quality for biomaterials 2

3 Quality Management System (QMS) A managerial tool that includes quality control with other operational procedures, such as standard operating policies (SOPs), to ensure consistent operations 3

4 Why implement QMS? Quality Management System It is estimated that between 15 20% of the cell lines used worldwide are either cross contaminated or misidentified. This means that worldwide many hundreds of millions of dollars spent in the biomedical and healthcare fields may have been wasted in producing false or misleading data. 4 Ref:

5 Why implement QMS? Quality Management System To improve organizational effectiveness Set goal, make action plans, measure performance, adaption plans To improve customer satisfaction Customer feedback improve Guaranteed quality of products and services To improve documentation Critical knowledge is documented and traceability of activities 5

6 Example What products for QMS? Many of culture collections are currently ISO 9001-certified or ISO accredited. ISO 9001: Requirements for a quality management system Management: planning, goals, reviewing progress Resources: people, tools, equipment Services or Product Realization Measurement, Analysis and Improvement ISO 17025: Requirements for the competence of testing and calibration laboratories NOW! The new ISO Biobank standards are coming 6

7 ISO/TC 276 Biotechnology 7

8 Why Biotechnology need standards? Safety and reliability Adherence to standards helps ensure safety, reliability and environmental care. Interoperability The ability of devices to work together relies on products and services complying with standards. Support of government policies and legislation Standards are frequently referenced by regulators and legislators for protecting user and business interests. Business benefits and Consumer choice Standardization provides a solid foundation upon which to develop new technologies and to enhance existing practices. 8

9 ISO/TC 276 Biotechnology Creation date: December 13, 2013 Secretariat: DIN, Germany Scope: Standardization in the field of biotechnology processes that includes the following topics: Terms and definitions; Biobanks and bioresources; Analytical methods; Bioprocessing; Data processing including analysis, validation, comparability and integration; Metrology 9

10 ISO/TC 276 Biotechnology: Members Data from on 6 th Feb, 2018 Secretariat: Germany - DIN Deutsches Institut für Normung e.v. (DIN) Participating members: 30 Observing members: 14 10

11 ISO/TC 276 Biotechnology: How to work ISO/TC 276 Biotechnology offers an independent international platform where all interested stakeholders can equally represent different opinions. ISO/TC 276 Biotechnology will evaluate existing standards before deciding whether it is necessary to create a new one. An open discussion on harmonization issues will be performed to establish International Standards; accepted worldwide and recognized from all stakeholders. Organizations in liaison (7): ANRRC; BBMRI-ERIC; EC; ESBB; ICH; ISBER; ISCT 11

12 Plenary Meetings and Working Group Meetings Germany Dec 12-13, 2013 Germany May 12-15, 2014 China Apr 13-18, 2015 Japan Oct 26-30, 2015 USA May 9-13, 2016 Ireland Oct 24-28, 2016 Korea May 7-13, 2017 Next meeting >> China (Beijing) in June

13 ISO/TC 276 Biotechnology: Structures Because of the large numbers of standards being developed, the work is delegated by the committee into 5 Working Groups Working Group Title Convenor WG 1 Terminology Dr. Pablo Serrano (DE) WG 2 Biobanks and bioresources Dr. Georges Dagher (FR) WG 3 Analytical methods Dr. Sheng Lin Ginson (US) WG 4 Bioprocessing Tatsuo Heki (JP) WG 5 Data processing and integration Martin Golebiewski (DE) 13

14 ISO/TC 276 Biotechnology: Scope of WG WG 1: Terminology Harmonization of existing terminology in the field of Biotechnology rather than on the standardization of new definitions WG 2: Biobanks and bioresources Elaborating a package of International Standards in the Biobanking field including human, animal, plant and microorganism resources for Research & Development (R&D) aspects, but excluding therapeutics WG 3: Analytical Methods Developing International Standards for accurate, reproducible and robust measurement and analysis in support for biologically relevant molecules and entities including nucleic acids, proteins, and cells 14

15 ISO/TC 276 Biotechnology: Scope of WG WG 4: Bioprocessing Developing International Standards to ensure the consistency in bioprocessing to contribute to the delivery of a consistent and reproducible quality products WG 5: Data Processing and Integration Developing International Standards for traceable, searchable, and interoperable data together with integrated data processing for biotechnology and life science 15

16 ISO/TC 276 Strategic business plan, 2016 ISO/TC 276 Biotechnology: Coordination 16

17 Current situation Data from on 6 th Feb,

18 ISO/TC 276 WG 2: Biobanks and bioresources Scope: Elaborating a package of International Standards in the Biobanking field including human, animal, plant and microorganism resources for Research & Development (R&D) aspects, but excluding therapeutics 18

19 WG 2 Biobanks and Bioresources Objectives Improve access to qualified samples Ensure/ increase the quality of samples Unify policies and procedures for biobanks, biological resources centers, and repositories Support exchange of biological material and related data among biobanks Facilitate trade and technology transfer Stimulate access of partners from the public and private sectors to highly qualified samples Increase stakeholder confidence and assurance Applicable for biobanks of different size 19

20 WG 2 Biobanks and Bioresources Currently, 9 standards are under developed by WG2. The most focusing is on ISO/DIS General requirements for biobanking which is intended to serve as an umbrella standard under which other more specific standards will be developed. (DIS = draft international standard) Biopreservation and Biobanking Furuta et al.,

21 ISO/DIS Infrastructure - Personnel competence - QMS - Equipment - QC - SOP - Sampling - Processing - Storage 21

22 Example ISO/DIS

23 How to implement ISO/TC 276? Biopreservation and Biobanking Allocca et al.,

24 Summary ISO/TC 276 deals with biotechnology processes: Terminology; Biobanks and bioresources; Analytical methods; Bioprocessing; Data processing and integration ISO/TC 276 WG 2 deals with Biobanks and bioresources: ISO/DIS describes the requirements for biological material from humans, animals, plants, microbes, soil, cell cultures, etc. Outputs from the standardization efforts will facilitate Technological development; Support national and international competitiveness; Contribute to the predictability of the regulatory environment; Support the exchange of goods and services through the elimination of technical barriers; Support market access 24

25 Standards improve global connectivity THANK YOU 25

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27 Situation of Thailand Representative organization 27

28 Questions? o Situation of Thailand???? o Why not just use existing guidelines? o Factors affecting completion and implementation of ISO/TC

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30 What is ISO? International Organization for Standardization The world s largest developer of voluntary International Standards An independent, non-governmental membership organization 162 countries 788 technical committee and subcommittee International Standards Each technical committee (TC) deals with a different subject. TCs are made up of experts of industry, academia, governmental institutions and other. 30

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32 Example Diversity of data format in different culture collection JCM NBRC CBS Criteria for the data sharing in online catalogues Minimum recommended information dataset for data publication 32

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