Good Laboratory Practice Discussion Forum

• Animal facility GLP requirements for operations e.g. building management and maintenance

  Patricia

  Patricia (17/06/2019)

  0
• computer systems and data protection

  Rita

  Rita (17/06/2019)

  0
• GLP validation involving different matrices

  Alison

  Alison (11/06/2019)

  0
• Inspection of CRO Archives - requirement?

  Kat

  Richard Pennicard (05/06/2019)

  10
• ISR failure

  Meet

  Meet (27/05/2019)

  0
• serious breach FDA

  MS

  RQA GLP Committee (24/05/2019)

  3
• GCLP: Bioanalytical data obtained in China

  Sus

  Sus (22/05/2019)

  0
• Validation Precision Question

  Damien

  RQA GLP Committee (22/05/2019)

  3
• Page Numbering

  Anon

  RQA GLP Committee (22/05/2019)

  1
• Reporting results from a Biomarker validation study in a separate long term stability study

  Anon

  RQA GLP Committee (21/05/2019)

  1
• Additional copies of Final Report after archiving?

  Anon

  Anon (21/05/2019)

  4
• Closure of deviations (GLP)

  Pauline Carr

  RQA GLP Committee (21/05/2019)

  1
• Archiving of non clinical material

  Joëlle

  RQA GLP Committee (21/05/2019)

  1
• QA Electronic Management System Software

  Derren Whitehead

  RQA GLP Committee (21/05/2019)

  1
• dose confirmation/accountability

  Anon

  RQA GLP Committee (21/05/2019)

  1
• Finalization of Study Plan without Sponsor Approval

  Anand Pandya

  RQA GLP Committee (21/05/2019)

  1
• Sponsor request to remove slides from archive

  Anon

  RQA GLP Committee (21/05/2019)

  1
• Recording Weights from Balance

  Jim

  RQA GLP Committee (21/05/2019)

  1
• Auditing of micro lab services to support a pHase 2 clinical study

  Jane Self

  RQA GLP Committee (16/04/2019)

  1
• Filing and Archiving of QA Audit Reports of Plans and Reports

  IBH - QA

  RQA GLP Committee (16/04/2019)

  1

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