MHRA GMP and GDP guidance
GMP and GDP documents published by the UK Medicines and Healthcare products Regulatory Agency (MHRA), grouped into information sheets, inspection deficiency statistics, and guidance. It includes information sheets explaining the Compliance Management and Regulatory Action processes, GMP inspection deficiency statistics on the deficiency types found repeatedly in inspections, and guidance and notices on individual topics such as inspection readiness and decentralised manufacturing. The deficiency statistics series is published infrequently, so the latest item may be several years old — check each document's year below and do not read old statistics as the current inspection trend. Always check the official source for legal status and the latest version.
- Re-inspection of site under Compliance Management
- Compliance Management - Specials Manufacturers
- Compliance Management - MIA MIA(IMP) and third country manufacture
- Compliance Management - Contract Laboratory
- Compliance Management - Active Substance
- Regulatory action – UK Wholesaler
- Re-inspection of site under Regulatory Action
- Regulatory Action - Specials manufacturers
- Regulatory Action - MIA MIA(IMP) and Third Country manufacture
- Regulatory Action Contract Laboratory
- Regulatory Action - Active Substance
- MHRA GMP Deficiency Data 2019
- MHRA GDP Inspection Deficiency Data 2016
- Good manufacturing practice deficiencies 2016
- Good manufacturing practice deficiencies 2015
- Good manufacturing practice inspection deficiencies 2013
- Good manufacturing practice inspection deficiencies April to June 2012
- Good manufacturing practice inspection deficiencies April 2011 to March 2012
- Good manufacturing practice inspection deficiencies April 2010 to March 2011
- Responding to a GMP/GDP post inspection letter
- Decentralised manufacture: UK Guideline on Good Manufacturing Practice (GMP)
- Access Consortium Good Manufacturing Practice (GMP) Statement
- Good manufacturing practice: conflicts of interests
- Clinical trials for medicines: good manufacturing practice and radiopharmaceutical investigational medicinal products
- Guidance for 'specials' manufacturers
- Out-of-specification investigations
