Good Manufacturing Practice Discussion Forum

• Shipping of IMP before BA/BE study approvals

  Colin Wilsher (23/10/2018)

  1
• Consider GMP of two countries for export?

  Uwe

  Uwe (03/10/2018)

  0
• relabeling IMP to be used in a compassionate use program

  Ilse

  Ilse (10/09/2018)

  0
• CMO QA Oversight

  Anon

  Veerraju (31/08/2018)

  1
• Method Validation

  CC

  Veerraju (31/08/2018)

  1
• autoclave validation

  Mary

  kattavarapu (15/08/2018)

  1
• Manufacturing of Heparin Sodium injection finished dosage form

  Anon

  kattavarapu (15/08/2018)

  1
• Trace the Freezer Temperature through Wireless System

  Harold

  RQA GLP Committee (03/07/2018)

  4
• Quality by Design (QbD)

  Andy McCallum

  Andy McCallum (14/05/2018)

  0
• Non-IMP Challenge Agent - need to audit

  Anon

  D. Chesnais (13/04/2018)

  3
• Supply of vaccine to investigator sites

  Anon

  D. Chesnais (09/04/2018)

  1
• Labeling requirements for small vials

  Christy

  Anon (05/04/2018)

  1
• QA Sign off

  Alison Costello

  Amit Bhatt (31/03/2018)

  3
• GMP Trainer

  ritta.jadeja

  Amit Bhatt (31/03/2018)

  6
• EU GDP and clinical trials

  JS

  Jon (01/03/2018)

  3
• Phase 1 study question

  Anon

  RQA GMP Committee (12/02/2018)

  1
• Categorisation of vendor audits

  Anon

  Anon (22/01/2018)

  4
• Local label requirement

  Anon

  Anon (29/11/2017)

  0
• Reporting Change of Scientist in C of As

  Alan Ling

  Alan Ling (27/11/2017)

  0
• GMP/GDP audit scheduling

  Anon

  JillianWright (11/10/2017)

  2

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