Good Manufacturing Practice Discussion Forum

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

  Ferenc

  Ferenc (04/06/2020)

  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
• TSE/BSE Statements

  Ferenc Erdos

  Ferenc Erdos (10/04/2020)

  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
• IMP or NIMP?

  Anon

  VBZ (28/08/2019)

  2
• Closure of deviations (GLP)

  Pauline Carr

  RQA GLP Committee (21/05/2019)

  1
• Auditing of micro lab services to support a pHase 2 clinical study

  Jane Self

  RQA GLP Committee (16/04/2019)

  1
• Optical inspection of injections

  AQEEL AHMED SOOMRO

  AQEEL AHMED SOOMRO (04/04/2019)

  0

Share your experience on trustpilot.com