Good Manufacturing Practice Discussion Forum

• QA approval of SOPs

  Steve

  RQA GLP Committee (20/10/2021)

  7
• Operational Qualification

  Scott Gillingwater

  RQA GLP Committee (20/10/2021)

  1
• Stability Testing in the EU?

  Anon

  GMP Committee response (15/10/2021)

  1
• Sourcing/use of marketed products in GB/EU trials after December 2021

  Anon

  Anon (01/10/2021)

  0
• Armed or Alarmed? Share your thoughts on alert management, and how you manage EUFMD alerts as a pharma manufacturer by completing this survey

  EU ALERT MANAGEMENT SURVEY

  EU ALERT MANAGEMENT SURVEY (27/09/2021)

  0
• CTR Annex VI and on-site expiry extension re-labelling

  Ferenc

  Ferenc (10/09/2021)

  0
• Label contents - GMP Annex 13 vs CTR Annex VI

  Ferenc

  Ferenc (10/09/2021)

  0
• Importing IMP from EU/EEA countries (so called “Listed” countries) to GB sites

  GMP Committee

  GMP Committee post (23/08/2021)

  2
• coffee morning to discuss upcoming issues

  GMP committee

  Derek Murphy (12/08/2021)

  1
• sharing of audit reports

  Anon

  Marion D (05/08/2021)

  2
• The new UK clinical trial submission process

  GMP Committee

  GMP Committee (26/07/2021)

  0
• Clinical Trial Regulation (CTR) 536/2014 is comming

  GMP Committee

  GMP Committee (26/07/2021)

  0
• OOS or deviation?

  Shahriar

  The GMP Committee (21/06/2021)

  1
• Local label requirement

  Anon

  Alma (16/06/2021)

  1
• IMP preparation at clinical site pharmacy

  Anon

  Dominique Chesnais (10/06/2021)

  1
• Auxiliary medication labelling

  Ferenc

  Dominique Chesnais (01/06/2021)

  5
• EU GMP Guideline update

  Jane Self

  Jane Self (14/05/2021)

  2
• Rerelease of finished product in the EU

  Conor

  GMP Committee response (30/04/2021)

  2
• Distributed Manufacturing

  Jennifer Bell

  Jennifer Bell (27/04/2021)

  0
• When the QP declaration can be issued for a product?

  Ferenc Erdos

  GMP Committee response (13/04/2021)

  5

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