GLP Legislation and Guidance

 

AGIT (Arbeitsgruppe Informationstechnologie) - Swiss IT Working Group: AGIT Website

 

Guidelines on computerised systems

01. Good Laboratory Practice (GLP): AGIT – Guidelines for the Acquisition and Processing of Electronic Raw Data (PDF, 288 kB, 31.01.2018)

02. Good Laboratory Practice (GLP): AGIT – Guidelines for the Archiving of Electronic Raw Data (PDF, 287 kB, 31.01.2018)

03. Good Laboratory Practice (GLP): AGIT – Guidelines for the Change Management and Risk Assessment (PDF, 235 kB, 31.01.2018)

04. Good Laboratory Practice (GLP): AGIT – Development and Validation of Spreadsheets (PDF, 615 kB, 31.01.2018)

05. Good Laboratory Practice (GLP): AGIT – Management of electronic SOPs (PDF, 231 kB, 31.01.2018)

06. Good Laboratory Practice (GLP): AGIT – Guidelines for Collaboration with external IT Service Providers (PDF, 221 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

09. Good Laboratory Practice (GLP): AGIT – Position Paper regarding Is it acceptable to destroy the paper originals of raw data and related study documentation if an image of the paper is captured in an electronic form (e.g. scanned)? (PDF, 151 kB, 31.01.2018)

10. Good Laboratory Practice (GLP): AGIT - Position Paper 2: Is a formal validation of spreadsheets used for data processing in a GLP study, in any case mandatory? (PDF, 796 kB, 13.10.2020) (NEW)

 

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

03. FDA GLP Regulations

04. 21 CFR 11 Guidance for Industry Electronic Records; Electronic Signatures

05. GLP Warning Letters

 

RQA's Good Laboratory Practice webpage Click here