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)
Are you a new applicant establishing a small wholesale dealers’ operation; and do you need guidance for creating written procedures?
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.
We have today updated the sidebar of the MHRA Inspectorate Blog to provide access to the MHRA Inspectorate organogram.
Earlier this week we published the 2016 GMP inspection deficiency data trend.
In the coming weeks, you will notice that it’s much quieter than usual on the MHRA Inspectorate blog. It’s because between midnight on Friday, 21 April and the general election on 8 June is the pre-election period.
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.