In part 2 of our series on QP Certification and Batch Release we concentrate on the application of Annex 16 to Investigational Medicinal Products (IMPs)
Our GDP inspectors often receive queries from wholesaler distributors asking in what instances agreements are required for the purposes of fulfilling pharmacovigilance requirements.
Last week we published the 1st April 2015 to 31st March 2016 GCP Inspection metrics report.
To help GLP organisations pro-actively improve compliance we are sharing the 2015 inspection metrics and examples also seen over the last 12 months
An update on the use of short notice and unannounced GMP inspections
This post describes the main issues seen when freezers are used by pharmaceutical wholesalers and provides an MHRA GDP inspectors’ view on possible ways to address them.
Earlier this week we published the 2016 GMP inspection deficiency data trend.
This post focuses on Computer System Validation (CSV) and is a combination of a case study seen at a single organisation and some of the common findings GCP Inspectors have seen across a number of recent inspections.
Previously, we have reminded importers of unlicensed medicines that Centrally Authorised medicines are the subject of Marketing Authorisations from the EMA, valid in all Member States and therefore cannot be notified for import into the UK as unlicensed medicines, unless …
The first post in this series described the importance of organisational behaviour on the success of data integrity control measures. Behavioural issues are often unsuitable for technical guidance, but the Inspectorate blog provides an opportunity to address this complex issue.
