IPEC e-newsletter - Excipients Insight April 2017 - 30-04-17


Inside this issue


MHRA says quality system issues head 2016 deficiency list

Problems with quality systems topped the list of Good Manufacturing Practice (GMP) inspection deficiencies recorded by the UK Medicines and Healthcare products Regulatory Agency (MHRA) last year.

The data applies only to dosage form inspections, but give a flavour of the issues that most commonly came to the attention of inspectors during the 324 site visits carried out last year.  The ranking appears as follows:

  1. Quality system;
  2. Sterility assurance;
  3. Production;
  4. Complaints and recall;
  5. Qualification/validation;
  6. Premises & equipment;
  7. Computerised systems;
  8. Personnel;
  9. Documentation; and
  10. Quality control.

Quality systems also topped the list in 2015, but documentation and quality control issues were encountered more frequently in that year, appearing at positions three and four just behind complaints and recall.

With regard to quality systems (Chapter 1), there were multiple examples of deficiencies related to incident investigations and corrective and preventive action (CAPA) implementation, for example when deviation reports did not contain sufficient information to describe investigations fully, there was a lack of management oversight of the quality system or when there was a lack of control on change control management.

The full 100-page report is available here.




Copyright © 2005 - 2018 IPEC Europe - International Pharmaceutical Excipients Council