MHRA publishes report on 2016 GMP inspection deficiencies

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has released details of GMP inspection deficiencies from last year.

Overall, the number of MHRA inspections increased by 7% in 2016 compared to 2015. Broken down, this equated to 3 more overseas inspections and 18 more UK inspections.

The report breaks down the most cited deficiencies, rated by numbers of critical, major and other findings.

Top of the list again (as it was for 2015) are Quality System deficiencies, racking up 38 critical, 449 major and 772 other findings. In contrast to 2015, second, third, fourth and fifth in the list were Sterility Assurance, Production, Complaints and recalls and Qualification/Validation. Out of the top 5 in 2015, only Complaints and Recalls and Quality System findings remain, with Documentation, Quality Control and Computerised Systems dropping to numbers 9, 10 and 7 respectively. However, the top 10 deficiency groups in general remain very similar over both years only with the rankings changing.

Chapter 1 of the EU Guidelines for GMP deals with the Pharmaceutical Quality System. The report identifies sections 1.4 and 1.8 as those with the most amount of findings, which is perhaps unsurprising since Section 1.4 deals with 17 specific requirements that make a Pharmaceutical Quality Assurance System suitable for the manufacture of medicinal products, and section 1.8 deals with the basic principles of GMP.

Examples of deficiencies are provided, amongst which are the following:

  • Inadequacy of CAPAs and overdue CAPAs
  • Deviation procedures lacking in sufficient detail
  • Management failing to ensure an effective Quality System was in place and implemented, as well as ineffective reactions from management to poor key performance indicators and poor deficient management review processes
  • Issues relating to change controls including lack of post-implementation review of effectiveness.

The most significant number of findings in Chapter 2 of GMP “Personnel” were relating to a lack of, or inadequate, training. In Chapter 3 “Premises and Equipment”, the most amount of findings were in relation to section 3.19, suitable storage areas including control of temperature and humidity, and 3.41, calibration and checking of measuring, weighing, recording and control equipment. Chapter 4 relates to “Documentation”, and the highest number of findings in this Chapter was in Section 4.9 which mandates that any alterations to entries on documents should be signed, dated and the original information able to be read. For Chapter 5 “Production”, there is a cluster of critical findings around Sections 5.18 through to 5.27 – these sections relate to prevention of cross-contamination, validation and starting materials. Critical findings for Chapter 6 “Quality Control” relate to GLP and documentation, and there were no critical findings for Chapter 7 “Outsourced Activities”. However, Chapter 8 “Complaints and Recalls” sees a cluster of critical deficiencies from Section 8.10 to 8.15, relating to investigations and decision making. Chapter 9 “Self Inspection” shows 1 critical finding in the Principle and the majority of other findings in Section 9.1 relating to self-examination which should follow a pre-arranged programme.

The report can be found here.