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UK GLP Legislation - Medicines and Healthcare products Regulatory Agency (MHRA)

GLP Statutory Instrument 1999 No. 3106 - amended by SI 2004/0994

UK GLPMA Guide to UK GLP Regulations 1999


List of MHRA GLP Guidance Documents available on their website:

  • "Policy on the Use of Non-GLP Compliant Facilities for the Conduct of Study Phases", reviewed January 2015
  • Retention of Study Data and Supporting Records for Inspection Purposes, reviewed January 2015
  • "REACH: Registration, Evaluation, Authorisation and restriction of Chemicals", reviewed January 2015
  • "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
  • "Good Laboratory Practice: GLPMA Expectations for Audit of the QA Programme", reviewed January 2015
  • "Guidance on the Content of Quality Assurance Statements", reviewed January 2015
  • "Good Laboratory Practice GLPMA Expectations When Using a Contract Quality Assurance Service", reviewed January 2015
  • Guidance on the use of GLP Study Report Amendments (april 2015)
  • 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 types of inspection, study audits, regulatory or enforcement action and collation and trending of deficiencies.


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