GMP Short Notice and Unannounced Inspections

An interesting blog post from the UK MHRA:

The Human Medicines Regulations 2012 as amended; regulation 325 ‘Rights of Entry’ states that an inspector may at any reasonable time enter premises. This allows for the MHRA to perform inspections both at short notice (may be a few days) or unannounced (no notice given). The use of these inspection types allows us to investigate issues that pose a significant risk to public health without obstruction and to work efficiently. We spend a lot of time planning and scheduling inspections but unfortunately there are times when things don’t go to plan and we can find ourselves with the following scenarios:

1. There are times when we have no choice for logistical or health & safety reasons but to cancel or postpone a planned inspection at very short notice (for example because an inspector can no longer travel and there is no other available staff to back fill).
2. A planned inspection finishes early or is postponed at the last minute (for example if a site is found not to ready to be inspected or an incident at the site means we can no longer inspect).
3. Risk information dictates a change to the prioritisation of an inspection.
4. A last-minute change to meeting requirements means some inspectors are then free to inspect.

See more at: MHRA

Posted by Dr. Tim Sandle