Good Manufacturing Practice Discussion Forum

• MP for self-administration_temperature monitoring

  Alexey question from GCP DF

  Alan Pipe on behalf of the GMP Committee (19/02/2013)

  2
• Can GMP-validated method be used to analyse samples from GLP-Tox study?

  Dr. Peter Vanhoenacker

  Alan Pipe on behalf of the GMP Committee (19/02/2013)

  3
• EU Chapter 1 Change Control

  Anon

  Alan Pipe on behalf of the GMP Committee (16/02/2013)

  1
• Volunteers Inhale substance what documentation

  Anon first put on GCP Forum

  Alan Pipe on behalf of the GMP Committee (27/11/2012)

  1
• Validation of temperature loggers

  Anon

  Alan Pipe on behalf of the GMP Committee (21/09/2012)

  3
• Verification/calibration of Class A Glassware

  Anon

  Alan Pipe on behalf of the GMP Committee (21/09/2012)

  1
• Mr.

  Prateek Goyal

  Alan Pipe on behalf of the GMP Committee (20/08/2012)

  1
• stability of IPs dispensed in polythene sachets

  Santhosh Kumar

  Alan Pipe on behalf of the GMP Committee (10/08/2012)

  2
• GMP Training Record

  Anon

  Alan Pipe on behalf of the GMP Committee (31/05/2012)

  1
• Archive destruction when the client no longer exists

  Anon

  Alan Pipe on behalf of the GMP Committee (22/05/2012)

  2
• Distinguishing between GLP/GMP & research labs

  Anon

  BARQA GLP Committee (21/05/2012)

  4
• Director of QA

  Anon

  Alan Pipe on behalf of the GMP Committee (12/04/2012)

  1
• QP Release

  Anon

  Alan Pipe on behalf of the GMP Committee (24/02/2012)

  1
• Serialisation

  David

  Alan Pipe on behalf of the GMP Committee (13/08/2011)

  1
• IMP Marketed Product Relabelled

  Anon

  Alan Pipe on behalf of the GMP Committee (13/08/2011)

  1
• API audit for US investigational product?

  QA Manager

  Alan Pipe on behalf of the GMP Committee (13/08/2011)

  1
• Relabeling of IP (shorter shelf life)

  Daniel Korner

  Alan Pipe on behalf of the GMP Committee (20/04/2011)

  2
• Importing IMP from USA

  QA Manager

  Alan Pipe on behalf of the GMP Committee (20/04/2011)

  1
• Risk Assessment

  Anon

  anon (14/04/2011)

  2
• Feedback on new Part II

  AEK

  BARQA Office (21/01/2011)

  1