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Guideline for Auditing Clinical Laboratories

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Notes

  1. 1 A revised version of this guideline was published in the International Journal of Pharmaceutical Medicine 2005; 19 (2): 89–96.[2]

References

  1. European Network of GCP Auditors and Other GCP Experts. The ENGAGE guideline: an optional guideline for good clinical practice compliance and quality systems auditing. EFGCP News 1998 Sep

    Google Scholar 

  2. European Forum for Good Clinical Practice Audit Working Party. Revision of the ENGAGE auditing guideline: an optional guideline for good clinical practice compliance and quality management systems auditing. Int J Pharm Med 2005; 19 (2): 89–96

    Article  Google Scholar 

  3. CFR Part 11. Guidance for Industry: part 11, electronic records; electronic signatures. Fed Reg 1997 Mar 20; 62 (54): 13430–66

    Google Scholar 

  4. ISO 9000:2000. Quality management systems -fundamentals and vocabulary. Geneva: International Organization for Standardization, 2000 Dec

    Google Scholar 

  5. ISO/IEC 17025. General requirements for the competence of testing and calibration laboratories. Geneva: International Organization for Standardization, 2005

    Google Scholar 

  6. European Commission. EN 45001: general criteria for the operation of testing laboratories. Brussels: CEN/CENELEC, 1989

    Google Scholar 

  7. Clinical Laboratory Improvement Amendments [online]. Available from URL: http://www.cms.hhs.gov/clia/ [Accessed 2005 Aug 17]

  8. CPMP/ICH/381/95. ICH Harmonised Tripartite Guideline. Q2A: text on Validation of analytical procedures. International Conference on Harmonisation. Adopted Jul 1995 [PAB/PCD Notification no. 755]. Fed Reg 1995 Mar 1; 60: 11260

    Google Scholar 

  9. CPMP/ICH281/95. ICH Harmonised Tripartite Guideline. Q2B: validation of analytical procedures: methodology. International Conference on Harmonisation. adapted Oct 1997 [PMSB/ELD Notification no. 338]. Fed Reg 1997 May 19; 62 (96): 27463–7

    Google Scholar 

  10. Committee for Proprietary Medicinal Products. CPMP/EWP/QWP/1401/98. Note for guidance on the investigation of bioavailability and bioequivalence. Adopted Jul 2001 [online]. Available from URL: http://www.emea.eu.int/pdfs/ human/ewp/140198en.pdf [Accessed 2005 Aug 17]

    Google Scholar 

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Acknowledgements

The finalisation of the guideline would not have been possible without a core group of authors acknowledged below: Susanne Studer (Roche), Birthe E. Nielsen (H. Lundbeck A/S), Sylvia Kranich (SK-Consult), Beat Widler (Roche), Hans Guenther Stelzer (CQC), John Baker (Norvatis), Finn Ahlmann-Ohlsen (Novo Nordisk A/S), Brian Cheetham (BCQM) and Guy Nys (Bristol-Myers Squibb).

All rights in this document are reserved by the European Forum for Good Clinical Practice (EFGCP), an international not-for-profit organisation chartered under Belgian law. The EFGCP hereby gives permission for this document to be freely reviewed, abstracted, reproduced, or translated. This document may not be sold in conjunction with commercial purposes without the express written permission of the EFGCP. The EFGCP would appreciate receiving two copies of any translation.

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Crawley, F.P. Guideline for Auditing Clinical Laboratories. Int J Pharm Med 19, 289–299 (2005). https://doi.org/10.2165/00124363-200519050-00006

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