Good Laboratory Practice Discussion Forum

• Role, responsibility and reference to EMA (On GCP discussion forum I was asked to place the question here)

  Lise

  peter smith (15/01/2021)

  1
• Analyst personnel blinding

  Anon

  Anon (13/01/2021)

  0
• Study Plan and Report

  Anon

  Tim Stiles (12/01/2021)

  1
• Import License needed from non EU country to Germany?

  Anon

  Juergen Kaetzler (22/12/2020)

  7
• US FDA BIMO GLP/GCP Inspectional Observations for Fiscal Year 2020

  Aldwin Aldana, MS, RQAP-GLP, MRQA

  Aldwin Aldana, MS, RQAP-GLP, MRQA (17/12/2020)

  0
• System Suitability Test required for GLP work?

  Pauline Carr

  Alex Johnson (13/12/2020)

  2
• Sops and Methods

  Anon

  RQA GLP Committee (20/11/2020)

  2
• Missing raw data become a GLP exeption?

  Joseph

  RQA GLP Committee (20/11/2020)

  1
• Staff blood samples

  Anon

  RQA GLP Committee (20/11/2020)

  2
• Phase Plan vs Study Plan

  Anon

  RQA GLP Committee (20/11/2020)

  2
• Move to electronic archiving of final reports

  Anon

  RQA GLP Committee (20/11/2020)

  2
• Signing of Study Plan Amendment

  Marion

  RQA GLP Committee (20/11/2020)

  1
• Managing GLP and Non-GLP Studies

  Anon

  RQA GLP Committee (20/11/2020)

  2
• Remote working Study Director

  Anon

  RQA GLP Committee (19/11/2020)

  1
• Statement of Retest Period / Shelf Life for test item: QA review and signature necessary?

  anon

  RQA GLP Committee (19/11/2020)

  1
• ADA to non-GLP

  Sus

  RQA GLP Committee (19/11/2020)

  3
• Test Article Characterization Requirement of an ethanolic extract of a grounded test article

  anon

  RQA GLP Committee (19/11/2020)

  1
• MHRA Guidance on the use of GLP Study Report Amendments

  Ian

  RQA GLP Committee (19/11/2020)

  1
• freezer location

  Maira

  RQA GLP Committee (19/11/2020)

  4
• Test Item characterisation

  AllenWakly (19/11/2020)

  3

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