Good Manufacturing Practice Discussion Forum

• Active Substance Registration

  Jon

  Jon (15/11/2019)

  2
• 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

  kirimC (23/08/2019)

  2
• 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
• GMP Trainer

  ritta.jadeja

  Hima Bindu (29/03/2019)

  7
• Auxiliary medication labelling

  Ferenc

  Ferenc (18/03/2019)

  2
• Creating a QMS from the ground up

  Hannah

  GMP Committee (08/03/2019)

  5
• EudraLex - Volume 4 - Online Training

  Ashley Smith

  GMP Commitee (08/03/2019)

  1
• Porcine content in capsules and ICF

  Sabrina

  Sabrina (11/12/2018)

  2
• Product manufacturing record

  Kaushik

  elmaasheley147 (06/12/2018)

  2
• relabeling IMP to be used in a compassionate use program

  Ilse

  Anon (15/11/2018)

  1
• Consider GMP of two countries for export?

  Uwe

  rakesh Chaurasia (12/11/2018)

  1
• Shipping of IMP before BA/BE study approvals

  Anon

  Colin Wilsher (26/10/2018)

  3

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