EU pharmacovigilance inspectors detect quality management system defects
More than 75 deficiencies were picked up, comprising one critical and 40 major problems
Issues associated with quality management systems were the most common problem discovered by European Union (EU) pharmacovigilance inspectors during 2014 following inquiries requested by the European Medicines Agency (EMA) committee for medicinal products for human use.
EMA’s annual report of the Pharmacovigilance Inspectors Working Group for 2014 said 79 deficiencies were discovered in these investigations, comprising one critical, 40 major and 38 minor problems. Of these, 18 were focused on quality management system problems; 14 on problems with individual case study adverse event expedited reporting; 10 on communication with national consumer agencies; 10 on organisational structure difficulties; six on clinical trials; six on weakness in qualified persons responsible for pharmacovigilance (QPPV); and smaller numbers on periodic adverse event reporting; archiving; computerised pharmacovigilance systems; master files; and safety data analysis.
The report noted that inspections 'are prioritised based on the potential risk to public health, the nature of the products, and extent of use', plus the number of products that a pharmaceutical company has on the EU market and other risk factors.
Inspectors are supposed to determine whether a pharmaceutical firm 'has the personnel, systems and facilities in place to meet their regulatory pharmacovigilance obligations' under rules for EU marketing authorisations.