Good Laboratory Practice Discussion Forum

• First GLP study without SOP

  Anon

  Anon (12/08/2019)

  0
• QA line management

  leanne

  leanne (08/08/2019)

  0
• biological sample transfer

  Anon

  Anon (08/08/2019)

  0
• QA inspection of e-data during live phase

  Anon

  Anon (05/08/2019)

  0
• ISR failure

  Meet

  RQA GLP Committee (05/08/2019)

  2
• Final report issue date

  Anna

  Anna (25/07/2019)

  2
• Method Validation Question

  Anon

  RQA GLP Committee (25/07/2019)

  2
• Creating a PDF 'true copy' of paper field documents

  Anon

  RQA GLP Committee (25/07/2019)

  1
• Study Director

  Prathibha

  RQA GLP Committee (25/07/2019)

  1
• Final Report Amendment after 3 yrs

  Anand Pandya

  RQA GLP Committee (25/07/2019)

  1
• HPLC Method of analysis

  Prathihba

  RQA GLP Committee (25/07/2019)

  1
• GCLP: Bioanalytical data obtained in China

  Sus

  RQA GLP Committee (25/07/2019)

  3
• Equipment qualification

  Anon

  RQA GLP Committee (25/07/2019)

  1
• Animal facility GLP requirements for operations e.g. building management and maintenance

  Patricia

  RQA GLP Committee (25/07/2019)

  1
• computer systems and data protection

  Rita

  RQA GLP Committee (25/07/2019)

  1
• GLP validation involving different matrices

  Alison

  RQA GLP Committee (25/07/2019)

  1
• Notification of Changes Form?

  Anon

  RQA GLP Committee (08/07/2019)

  1
• Warning letters (483s or inspection report))

  Meet

  RQA GLP Committee (08/07/2019)

  1
• Additional copies of Final Report after archiving?

  Anon

  RQA GLP Committee (08/07/2019)

  6
• Early return of raw data from archive

  Anon

  RQA GLP Committee (28/06/2019)

  1

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