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Process Licensing Office joins the Inspectorate
The Process Licensing Office has today joined the Inspectorate to become the Inspectorate & Process Licensing Group.
Good manufacturing practice
PIC/S press release following April 2018 meeting
From 16 to 18 April 2018 the PIC/S Committee and PIC/S Executive Bureau meetings took place in Geneva, Switzerland.
VHP (Vapour Hydrogen Peroxide) Fragility
This post provides guidance around the use of VHP for sterilization purposes
Guidance around the urgent supply of unlicensed medicines imported out-of-hours by UK hospitals.
This post provides guidance around the urgent supply of unlicensed medicines that have needed to be imported out of hours by UK hospitals.
MHRA’s GXP data integrity guide published
The MHRA’s GXP data integrity guide has been published today.
Out of Specification Guidance
The issue faced when dealing with out of specification (OOS) results is as much a challenge now as it ever was. This post provides some guidance on how to handle OOS results.
GMDP Symposium 2017- GMP Days
The 2017 GMP Symposium was the riskiest ever! This year the theme of Risk Management ran throughout the various sessions at the event.
An Inspector Calls: Part 2, GMP Short Notice and Unannounced Inspections cont
Potential patient safety issues, serious breaches of GMP or suspected criminal activity frequently trigger short notice or unannounced inspections
Looking for a New Challenge in 2018?
Whilst we progress our latest recruitment campaign for GMDP Inspectors, Ian Holloway reflects on 30 years of working for the Medicines Regulator.
2018 MHRA Laboratories Symposium
The Inspectorate laboratories group conducts a diverse number of inspections both internationally and across the United Kingdom.