Good Manufacturing Practice Discussion Forum

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

  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
• [FREE]: US FDA CDER Small Business and Industry Assistance (SBIA) Learn Online Training Repository

  Aldwin Aldana

  Aldwin Aldana (16/02/2021)

  0
• Shipments of IMP to Northern Island from Great Britain

  Anthony Moult

  Anthony Moult (21/01/2021)

  0
• Brexit impact on IMPs from Great Britain to Switerland

  GMP Committee Member

  GMP Committee Member (21/01/2021)

  0
• GMP manfacture for clinical trials in Asia

  McSweeney

  Anthony Moult (14/01/2021)

  2
• Relabel IP on site

  Eason

  Response from the committee (14/01/2021)

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

  Anon

  Juergen Kaetzler (22/12/2020)

  7
• ANSM advice

  TooManyDaves

  Dominique Chesnais (03/11/2020)

  2
• Change request and SOPs

  Alexia

  GMP Committee response (08/10/2020)

  1

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