Good Manufacturing Practice Discussion Forum

• 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
• CMO QA Oversight

  Anon

  Anon (05/05/2017)

  0
• Shipping of IMP to Clinical Site before QP release

  Anon

  GCP Com (29/11/2016)

  1
• Ceilings in Cosmetic Production

  Brian Aldridge

  Julie Giblin on behalf of the GMP Committee (07/09/2016)

  1
• Product manufacturing record

  Kaushik

  GMP Committee (15/02/2016)

  1
• True copies of raw data

  Anon

  RQA GLP Committee (07/01/2016)

  1
• electronic SOPs management system

  Assia

  Claire van Leersum (25/11/2015)

  1
• Pooling of IMP

  Susanne Erman-Bech

  Derek Murphy (25/11/2015)

  1
• Bulk Batch filled into 3 DP Batches

  Jim

  Claire van Leersum (25/11/2015)

  1
• Site Master File

  Anon

  Claire van Leersum (25/11/2015)

  1

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