Als een onafhankelijke senior consultant verleen ik advies en training op het gebied van GCLP en GLP voor nationale en internationale farmaceutische industrie en gezondheidszorg organisaties.

 

Consultancy

  • Kwaliteitsmanagement systeem
  • Quality Assurance programma
  • Quality Document systeem
  • Ontwikkelen en schrijven van SOPs
  • GCLP/GLP implementatie en naleving

 

Training

OECD series over de Principes van Goede Laboratorium Praktijk
No 1: OECD Principles on Good Laboratory Practice (as revised in 1997)

GLP consensus documenten

No 4: Quality Assurance and GLP (revised 1999)
No 5: Compliance of Laboratory Suppliers with GLP Principles (revised 1999)
No 6: The Application of the GLP Principles to Field Studies (revised 1999)
No 7: The Application of the GLP Principles to Short Term Studies (revised 1999)
No 8: The Role and Responsibilties of the Study Director in GLP Studies (revised 1999)
No 10: The Application of the Principles of GLP to Computerised Systems (1995; replaced by No 17: April 2016))
No 13: The Application of the OECD Principles of GLP to the Organisation and Management of Multi-Site Studies (2002)

Advies documenten van de Werkgroep GLP

No 11: The Role and Responsibility of the Sponsor in the Application of the Principles of GLP (1998)
No 15: Establishment and Control of Archives that Operate in Compliance with the Principles of GLP (2007)
No 17: Application of GLP Principles to Computerised Systems (April 2016)
[Note: this document replaces Consensus Document No. 10: The Application of the Principles of GLP to Computerised Systems]

No 19: Management, Characterisation and Use of Test Items (April 2018)

Leidraad voor beoordelende instanties

No 20: Guidance Document for Receiving Authorities on the Review of the GLP Status of NonClinical Safety Studies (Juli 2019)

Standpunten

No 18: The Relationship between the OECD Principles of GLP and ISO/IEC 17025 (2016)

The Use of Laboratory Accreditation with reference to GLP Compliance Monitoring (1994)

 

GCLP

Reflection paper on laboratories that perform the analysis or evaluation of clinical trial samples (2012)

 

GLP en de Brexit

Notice to stakeholders - Withdrawal of the United Kingdom and EU rules in the field of Good Laboratory Practice (GLP) (Brussels, 28 June2019)