Good Manufacturing Practice Discussion Forum

• Shipping of IMP to Clinical Site before QP release

  Anon

  GCP Com (29/11/2016)

  1
• Ceilings in Cosmetic Production

  Brian Aldridge

  Julie Giblin on behalf of the GMP Committee (07/09/2016)

  1
• Product manufacturing record

  Kaushik

  GMP Committee (15/02/2016)

  1
• True copies of raw data

  Anon

  RQA GLP Committee (07/01/2016)

  1
• electronic SOPs management system

  Assia

  Claire van Leersum (25/11/2015)

  1
• Pooling of IMP

  Susanne Erman-Bech

  Derek Murphy (25/11/2015)

  1
• Bulk Batch filled into 3 DP Batches

  Jim

  Claire van Leersum (25/11/2015)

  1
• Site Master File

  Anon

  Claire van Leersum (25/11/2015)

  1
• Common HVAC system

  Charif

  Claire van Leersum (25/11/2015)

  1
• Use of printed initials/date

  Alan Ling

  RQA GLP Committee (23/11/2015)

  2
• Sterilization

  RAJ

  Medical Devices Committee (05/10/2015)

  1
• manufacturing of oral & topical liquid preparation in same preparation tank

  Zaki Shahin

  Claire van Leersum (13/09/2015)

  1
• IMP or NIMP?

  Anon

  Claire van Leersum (13/09/2015)

  1
• Raw Data in GMP Facility Audit Reports

  Alan

  Claire van Leersum (11/09/2015)

  1
• Workmanship

  Kartikeya

  Claire van Leersum (11/09/2015)

  1
• process validation

  Batta Rajasekhar

  Batta Rajasekhar (27/06/2015)

  0
• QA approval of SOPs

  Steve

  RQA GLP Committee (18/06/2015)

  2
• Safety related triggers/threshold for quality investigations/batch record reviews

  Anon

  GPvP Committee (12/06/2015)

  1
• relabelling procedures

  A Hawkins

  RQA GMP Committee (12/05/2015)

  1
• Characterising impurities

  Richard

  RQA GLP Committee (17/02/2015)

  2