GOV.UK
Falsified Medicines Directive: Safety Features
Implementation of the FMD safety features in the UK
Good manufacturing practice
MHRA Laboratories Symposium 2019 ... plus GXP mailbox update
The MHRA Laboratories Symposium will be held on 13 March 2019 at the Novotel in London. Also ... we have recently changed the contact email address for the laboratories inspection group from glp@mhra.gov.uk to gxplabs@mhra.gov.uk
It pays to be compliant!
In a bid to drive improved compliance and to cover the cost of managing more resource-intensive cases, the Inspectorate intends to apply the existing office-based assessment fee more broadly.
Cross-contamination control and Health Based Exposure Limits (HBEL) Q&As
Q&As clarifying expectations for implementation of the HBEL guide and cross-contamination control requirements were published in April 2018
Process Licensing Office joins the Inspectorate
The Process Licensing Office has today joined the Inspectorate to become the Inspectorate & Process Licensing Group.
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.