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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
No.24 Position Paper on Quality Improvement Tools and GLP
No.24 OECD Position Paper on Good Laboratory Practice and IT Security
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)

Book
Good Clinical Practice Guide, MHRA 2012.

Northwick Park incident
Expert Scientific Group on Phase One Clinical Trials (Nov 2006) (Duff report)
MHRA report

EU Legislation - Eudralex
Eudralex

Method Validation
FDA Guidance for Industry – Bioanalytical Method Validation (2018) 
EMA Guideline on bioanalytical method validation

Videos
Whitehall Training - An Introduction to Good Clinical Laboratory Practice (GCLP) 2020 49:51 min
Whitehall Training - An Introduction to Good Laboratory Practice (GLP) 2020 53:05 min
Whitehall Training - In Introduction to Good Clinical Practice (GCP) 2020 47:07 min
What being compliant with GLP means in practice 2012 43:49 min
What is Good Laboratory Practice (GLP) 2019 2:02 min
Good Laboratory Practice 2018 1:40 min
Steps to Minimize the Data Integrity Risk 2021 4:37 min

Information Security
Information Security Awareness Training
IT Security resource in Learners’ Toolkit
Protecting yourself from Phishing Scams