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GLP Legislation and Guidance
AGIT (Arbeitsgruppe Informationstechnologie) - Swiss IT Working Group: AGIT Website
Guidelines on computerised systems
05. Good Laboratory Practice (GLP): AGIT – Management of electronic SOPs (PDF, 231 kB, 31.01.2018)
07. Good Laboratory Practice (GLP): AGIT – Validation of Computerised Systems (PDF, 395 kB, 31.01.2018)
08. Pipette Control (ZIP, 34 kB, 31.01.2018)
Position papers
European Medicines Agency (EMA)
Reflection Paper on guidance for laboratories that perform the analysis or evaluation of clinical trial samples (February 2012) Click here
Guideline on evaluating control samples in non-clinical safety studies: checking for Contamination with the test substance. (March 2005) Click here
Guideline on bioanalytical method validation (effective 01 Feb 2012) Click here
European Union (EU)
Most recent GLP documents: EU GLP webpage
Guidance for GLP facilities on the implementation and maintenance of a risk-based quality assurance programme. This is the MHRA Risk-based QA Programme paper that has now been adopted across the EU, meaning that it is acceptable for all EU GLP facilities to operate a risk-based QA Programme meaning the frequency of audits can be determined by risk, rather than once every three months or every study
11. 2004/9/EC–Inspection and verification of GLP (recodified)
12. 2004/10/EC–Harmonisation of laws, regulations and administrative provisions relating to the application of GLP (re-codified)
Cross-contamination of control samples with test item in animal studies (November 2004) Click here
Medicines and Healthcare products Regulatory Agency (MHRA)
13. GLP Statutory Instrument 1999 No. 3106-amended by SI 2004/0994
14. UK GLPMA Guide to UK GLP Regulations 1999
15. MHRA Use of non-GLP compliant facilities for the conduct of study phases
16. MHRA GLP Guidance Documents available on their website:
17. Guidance on implementing and maintaining risk-based quality assurance programme, September 2015
18. Selection and use of GLP Test Sites located outside the UK, April 2016
Within section 'Use of non-GLP facilities,' the guidance on completing the form (January 2015) contains useful information on formulation analysis, test item characterisation, field trial scenarios and information on claiming and not claiming GLP compliance
19. Retention of Study Data and Supporting Records for Inspection Purposes, reviewed January 2015
20. REACH: Registration, Evaluation, Authorisation and restriction of Chemicals, reviewed January 2015
21. Pesticide Efficacy Studies Intended for Submission to the United State Environmental Protection Agency: Possible Need for Compliance with the Principles of Good Laboratory Practice, reviewed January 2015
22. Good Laboratory Practice: GLPMA Expectations for Audit of the QA Programme, reviewed January 2015
23 Guidance on the Content of Quality Assurance Statements, reviewed January 2015
24. Good Laboratory Practice GLPMA Expectations When Using a Contract Quality Assurance Service, reviewed January 2015
25. Guidance on the use of GLP Study Report Amendments (April 2015)
26. Guidance on test types stated on GLP compliance statements, reviewed January 2015
MHRA Good Laboratory Practice: The Inspection Process: Click here to view the process, which covers inspection types, study audits, regulatory or enforcement action and collation and trending of deficiencies.
MHRA Blog We recommend that you sign up to or read relevant posts in the MHRA Inspectorate blog, e.g. Data integrity part II: MHRA Blog
Organisation for Economic Cooperation and Development (OECD) OECD GLP homepage
27. OECD Environment Monograph No. 1 gives the internationally accepted view of GLP. Find all OECD GLP documents here
28. OECD Information by Country Click here
29. OECD Test Guidelines Click here
30. Explanation of OECD Mutual Acceptance of Data (MAD) Click here
31. GLP: OECD Principles of GLP (1997)
32. GLP: (Codification Amendments Etc.) Regulations 2004
*NEW* FAQ section contains different questions to the EU FAQ, a good source of information if faced with similar questions in our roles.
Food and Drugs Administration (FDA)
01. List of FDA inspections of facilities that perform non-clinical laboratory studies
02. Comparison of FDA, EPA, OECD GLP
04. 21 CFR 11 Guidance for Industry Electronic Records; Electronic Signatures
RQA's Good Laboratory Practice webpage Click here