Good Manufacturing Practice Discussion Forum

• QP requirements for EC IMPs imported into UK after brexit

  Peter Baxter

  Peter Baxter (11/07/2020)

  0
• TSE/BSE Statements

  Ferenc Erdos

  Ferenc (08/07/2020)

  2
• Shared logins?

  Karen

  Karen (08/07/2020)

  0
• 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
• IP relabeling due to Sponsor's name change

  Anna

  Anna (19/06/2020)

  0
• 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
• Recommendations for basic GMP video

  Jane

  GMP Committee response (14/05/2020)

  2
• Practical guidance of the CMDh

  Dominique Chesnais

  Dominique Chesnais (24/04/2020)

  0
• Covid-19 experiences in the GMP sector

  GMP committee

  GMP committee (02/04/2020)

  0
• Auxiliary medication labelling

  Ferenc

  GMP Committee response (16/12/2019)

  3
• Active Substance Registration

  Jon

  GMP Committee response (16/12/2019)

  3
• Auditing a manufacturer

  Anon

  GMP Committee response (15/11/2019)

  1
• Annex 16 application to IMPs

  Anon

  GMP Committee response (15/11/2019)

  1
• Instrumentation, continuity of equipment service contracts

  ANON

  GMP Committee response (15/11/2019)

  1
• Sampling plan API

  Kaddour

  GMP Committee response (15/11/2019)

  1
• Retencion samples in Clinical Trials

  Ruth Lopez

  GMP Committee response (15/11/2019)

  2
• Retention Samples in Clinical Trials

  Ruth Lopez

  GMP Committee response (15/11/2019)

  3

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