MHRA data: Quality systems most common GDP deficiency in 2016
The UK regulator published 2016 inspection data this week, confirming it conducted 1428 audits and that – based on a representative sample – the most commonly observed major deficiencies from good manufacturing practices (GDP) related to quality systems.
Quality systems – as the MHRA defines them – cover the management of procurement, storage and supply of medicines. Examples of problems identified in 2016 include failure to analyse deviations and failure to implement change control procedures.
While a direct comparison with 2015 inspection data is impossible as a result of changes to GDP regulations – specifically drug export becoming a licensable activity – the 2016 data indicate that establishing compliant quality systems continues to be a challenge for distributors.
An MHRA spokesperson told us "the figures provided in the blog are based on a small sample (approximately 10%) and from that sample the highest was QMS. Without a full review and comparison of like for like data following a full inspection cycle against the new guidelines it is difficult to make definitive statements and draw trends.
"The intent of publishing this data is to assist wholesalers with the identification of weaknesses within their own processes and procedures with the ultimate aim of promoting greater levels of compliance” they added.
