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.
The supply chain for Active Pharmaceutical Ingredients (APIs) has been increasing in complexity for a number of years with the potential for a number of players to be involved, with multiple possible routes around the world available (significantly more than …
It was a case of “lights, camera, action!” for the GMP days of the 2016 MHRA Symposium, with speakers making use of video clips, music, and pictures in order to deliver key messages.
Hello and welcome to Reference Safety Information II. Hopefully you will all have read my first Reference Safety Information (RSI) post which focused on how the RSI should be Identifiable, Approved and Consistent.
We currently have a vacancy for a pharmaceutical assessor to join the Defective Medicines Report Centre (DMRC) team, working closely with the Inspectorate as part of the Inspection Enforcement and Standards Division of the MHRA.
The 2015 GMP inspection deficiency data trend has been published yesterday
In the October blog post we told you about the successful audit of the GMP Inspectorate under the JAP programme. Later that month the entire Inspectorate was assessed as part of the BEMA programme.
6 top tips for applicants submitting a Manufacturing Authorisation application or variation
My name is Lynsay Hunter and I am the newest recruit to the MHRA laboratories inspection team, having previously worked in a variety of laboratory and quality assurance roles. My first MHRA event was the annual laboratories symposium held in …
The 2017 Orange and Green Guides are almost ready for publication.
Traditionally, GDP (Good Distribution Practice) inspectors visit sites to confirm that holders of Wholesale Dealer’s Authorisations (WDA) are compliant with the requirements of legislation.