Good Laboratory Practice Discussion Forum

• Archiving in a timely manner

  Anon

  Richard Pennicard (13/04/2021)

  1
• OECD GLP Data Integrity Guidance document & significant regulatory updates

  Anon

  Anon (12/04/2021)

  0
• Description of Materials and Test Methods

  Anon

  Anon (08/04/2021)

  0
• OECD GLPs and Late Entries

  Kat

  Kat (07/04/2021)

  0
• Separation of Animal Control and Test Groups

  Alan Ling

  Caliluna (31/03/2021)

  2
• Reporting raw data vs derived data in final report

  Frits

  Frits (26/03/2021)

  0
• Requirements within stem cell area

  sus

  sus (24/03/2021)

  0
• Batch Failure within C of A

  Anon

  Anon (24/03/2021)

  1
• Is it mandatory to electronically records all the maintenance in GLP?

  Hülya NOYAN ÜZDÜRMEZ

  Hülya NOYAN ÜZDÜRMEZ (11/03/2021)

  0
• How to get hold of "old" MHRA GLP Compliance Statements?

  Thorsten Nowak

  Thorsten Nowak (08/03/2021)

  0
• Remote Study Director

  Anon

  RQA GLP Committee (26/02/2021)

  1
• SOP identification

  Anon

  Anon (24/02/2021)

  0
• [FREE]: US FDA CDER Small Business and Industry Assistance (SBIA) Learn Online Training Repository

  Aldwin Aldana

  Aldwin Aldana (16/02/2021)

  0
• User Requirement Specifications

  Anon

  Anon (16/02/2021)

  0
• Should bioanalytical method validations be performed to GLP ?

  sus

  RQA GLP Committee (15/02/2021)

  2
• GCP vs.GCLP

  HL

  RQA GLP Committee (15/02/2021)

  1
• Reporting a change to the CAS number 5 years after study completion-amendment without new report?

  Pam

  RQA GLP Committee (15/02/2021)

  1
• Health Authority Requirements for Retention Period of Clinical Trial Specimens (Blood, Urine, Feces, Biological Fluids)

  Aldwin Aldana

  RQA GLP Committee (15/02/2021)

  3
• UK MHRA GCLP Certification of Bioanalytical Laboratories for Clinical Trial Sample Testing

  Aldwin Aldana

  RQA GLP Committee (15/02/2021)

  3
• REACH studies

  sus

  RQA GLP Committee (15/02/2021)

  1

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