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.