Reading List for GLP and GCP

All GXP

Data Integrity Guidance and Definitions (MHRA 2018)

Data Integrity and Compliance with Drug CGMP (FDA 2018)

Good Laboratory Practice

Introduction to OECD GLP

UK GLP Regulations, SI 1999 No 3106; amendments, SI 2004 No. 994.

OECD Series on Principles of GLP and Compliance Monitoring

No. 1 OECD Principles on GLP
No. 5 Compliance of laboratory suppliers with GLP
No. 8 The Study Director
No. 13 Multi-site Studies
No. 15 Archives
No. 17 Computerised Systems
No. 17 Supplement on Cloud Computing
No. 19 Management, Characterisation and use of test items
No. 21 OECD Position Paper Regarding Possible Influence of Sponsors on Conclusions of GLP Studies
No.22 OECD GLP Data Integrity
No.23 QA and GLP

Archive of frequently asked questions

Good Clinical Practice

Clinical Trials Regulations, SI 2004, No. 1031; and amendments SI 2006 Nos. 1928, 2984, etc.

EMA Guideline for Good Clinical Practice ICH E6(R2) (CPMP/ICH/135/95)

Guidance for the Notification of Serious Breaches of GCP or the Trial Protocol, Version 6 (2020)