Q&As clarifying expectations for implementation of the HBEL guide and cross-contamination control requirements were published in April 2018
Good manufacturing practice
The Process Licensing Office has today joined the Inspectorate to become the Inspectorate & Process Licensing Group.
From 16 to 18 April 2018 the PIC/S Committee and PIC/S Executive Bureau meetings took place in Geneva, Switzerland.
This post provides guidance around the use of VHP for sterilization purposes
This post provides guidance around the urgent supply of unlicensed medicines that have needed to be imported out of hours by UK hospitals.
The MHRA’s GXP data integrity guide has been published today.
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.
The 2017 GMP Symposium was the riskiest ever! This year the theme of Risk Management ran throughout the various sessions at the event.
Potential patient safety issues, serious breaches of GMP or suspected criminal activity frequently trigger short notice or unannounced inspections
Whilst we progress our latest recruitment campaign for GMDP Inspectors, Ian Holloway reflects on 30 years of working for the Medicines Regulator.