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

With effect from 2013, the MHRA GxP Consultative Committee  meetings are to be consolidated into a single MHRA meeting. This meeting will be named the Stakeholder Engagement Meeting (StEM) to better reflect the proposed purpose of the meeting. It is anticipated that industry members will have more direct input in the future, either by raising topics or giving presentations on technical areas or other areas requiring an MHRA perspective.

 

GLP Consultative Committee Official Minutes and Deficiencies found 2011

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.