Good Manufacturing Practice Discussion Forum

• [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
• MHRA: New rules for January 2021

  Dominique Chesnais

  Dominique Chesnais (02/09/2020)

  0
• QP requirements for EC IMPs imported into UK after brexit

  Peter Baxter

  Syed Hoda (02/09/2020)

  2
• Batch Manufacturing Record review

  Anon

  GMP Committee response (01/09/2020)

  3
• TSE/BSE Statements

  Ferenc Erdos

  Ferenc (18/08/2020)

  4
• PSF QC

  Marion D

  GMP Committee response (17/08/2020)

  1
• Shared logins?

  Karen

  GMP Committee response (17/08/2020)

  2
• IP relabeling due to Sponsor's name change

  Anna

  Anna (13/07/2020)

  2
• QA approval of SOPs

  Steve

  GMP Committee response (29/06/2020)

  5
• Is CE mark needed for US Saline bags when using in an EU clinical trial?

  Ferenc

  GMP Committee response (29/06/2020)

  1
• GMP licence

  Anon

  Peter (29/05/2020)

  2
• Class VI - USP<88> - manufacturing contact surfaces

  TooManyDaves

  GMP Committee response (14/05/2020)

  1
• Site Master File

  Anon

  GMP Committee response (14/05/2020)

  1

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