New ECA Working Group starts first Project

17 November 2010

Many members of the European Compliance Academy (ECA) have recognised the need for a generic approach to the handling of OOS, OOE & OOT analytical results. Therefore, the new ECA Analytical Quality Control Working Group has defined its first project: the generation of a harmonised SOP on managing analytical deviations within the laboratory including OOS, OOE and OOT results. The project’s goal is to promote a harmonised approach within the EU by the publication of the final document on the ECA website by July 2011. To accomplish it the group has established a project task force.

The SOP will be confined to conventional chemical test analyses and related chromatographic, spectroscopic and electrochemical procedures. It is not intended for use in microbiological or bioanalytical tests directly but the general principles will apply.

To generate an acceptable SOP and associated flow chart, the Working Group’s steering committee has agreed to delegate the editorial and document generation tasks to Dr Chris Burgess and Dr Bernd Renger who will act as project coordinators as shown in the appended flow chart. They will be supported by a review team to complete the project task force. This team’s members are

  • acting as QC professionals in the own right and are not acting on behalf of their companies or employers.
  • committed to making comments and suggesting changes at the appropriate stages as shown in the project flow
  • required to make such comments and changes in a timely manner (any comments and suggestions will remain confidential to and anonymous outside the task force)

The review team will be able to manage all its project activities electronically.

Dr Burgess and Dr Renger will take into account the comments and suggestions from the review team within the framework and timescales defined in the project phases. The phases parallel to and following the formation of the review team are in detail:

  • Step 1 (by end of November 2010)
    Provision of a Draft Annotated OOS Flow Chart Version 01 by Dr Christopher Burgess (CB) and Dr Bernd Renger (BR) – parallel to recruiting interested ECA members for the review team. This team is supposed to be complete by end of December 2010.
  • Step 2 (by mid of February 2011)
    Comments to the Draft Annotated OOS Flow Chart Version 01 by the steering committee to agree on the proposal for the Draft Annotated OOS Flow Chart Version 02.
  • Step 3 (by mid of May 2011)
    The review team will receive the steering committee’s Draft Annotated OOS Flow Chart Version 02 for feedback and comments by end of February 2011. The review team's answers and comments are required by end of March 2011. The steering committee will review all comments and will develop a revised Draft Annotated OOS Flow Chart Version 03 taking into account the comments of the review team. In addition Dr. Christopher Burgess and Dr. Bernd Renger will prepare (in co-operation with the steering committee) a proposal for a Draft SOP Wording based on the Draft Annotated OOS Flow Chart Version 03, which will be circulated again to the review team for feed-back and comments within 2 weeks.
  • Step 4 (by mid of June 2011)
    The steering committee will compile the Draft OOS Flowchart Version 04 which will be incorporated in the Draft OOS SOP Version 02, which will be again circulated to the review team for final approval by e-mail.
  • Step 5 (by end of July 2011)
    After the approval of the OOS SOP Version 02 including the OOS Flow Chart Version 04 by the review team, this final document will be presented by the steering commiittee at ECA's Education Course "Out-of-Specification Results" (28-29 June 2011) in Munich, Germany. Members of the review team will receive a 50% discount for this ECA OOS Education Course.

Please also see the detailed flowchart for the project phases.

The final ECA OOS SOP and Flow Chart will also be published on ECA's Website in July 2011.

If you are interested in getting actively involved in the review team please send an e-mail to analytic@gmp-compliance.org or use the contact form on one the following sites.

 

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