Good distribution practice

Falsified Medicines Directive: Safety Features

Posted by: Tracy Moore, Posted on: 8 February 2019 - Categories: Compliance matters, Good distribution practice, Good manufacturing practice, Wider MHRA

Implementation of the FMD safety features in the UK

It pays to be compliant!

Posted by: Michelle Yeomans, Posted on: 11 January 2019 - Categories: Compliance matters, Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice, Good pharmacovigilance practice

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.

The Responsible Person named on the WDA- Part 3: Expectations for the engagement of consultants as contract RPs

Posted by: Madeleine Ault and Peter Brown, Posted on: 8 August 2018 - Categories: Compliance matters, Good distribution practice

This is the final of three posts centered around the Responsible Person named on a Wholesale Distribution Authorisation (WDA) and covers the engagement of a contract RP

Process Licensing Office joins the Inspectorate

Posted by: Mark Birse, Posted on: 1 August 2018 - Categories: Compliance matters, Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice, Good pharmacovigilance practice, Inside the Inspectorate

The Process Licensing Office has today joined the Inspectorate to become the Inspectorate & Process Licensing Group.

The Responsible Person named on the WDA -Part 2: Effective Appointment and Training

Posted by: Madeleine Ault, Posted on: 13 July 2018 - Categories: Compliance matters, Good distribution practice

This is the second in a set of three posts centred around the Responsible Person named on a Wholesale Distribution Authorisation (WDA). This post has been written to enhance the appointment of the RP.

The Responsible Person named on the WDA. Part 1: Raising the profile of the RP

Posted by: Madeleine Ault and Peter Brown, Posted on: 15 June 2018 - Categories: Compliance matters, Good distribution practice

This is the first in a set of three posts centered around the RP named on a WDA. This post provides information on external training recognition and training providers. The second of these three posts aim to enhance the appointment of the RP and the third post will place a particular emphasis on the engagement of a contract/consultant RP.