Good distribution practice

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.

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.

I don't believe it!

Posted by: Terry Madigan, Posted on: 25 May 2018 - Categories: Compliance matters, Good distribution practice

Guidance and examples of data integrity issues seen on GDP inspections.

PIC/S press release following April 2018 meeting

Posted by: Mark Birse, Posted on: 9 May 2018 - Categories: Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice, Good pharmacovigilance practice, Inside the Inspectorate

From 16 to 18 April 2018 the PIC/S Committee and PIC/S Executive Bureau meetings took place in Geneva, Switzerland.

Obtaining medicines for wholesale using prescriptions and an important update on attempted thefts from warehouses

Posted by: Tony Orme, Posted on: 3 May 2018 - Categories: Compliance matters, Good distribution practice

The GDP inspectorate has seen a growing number of false NHS and private prescriptions being used to obtain medicines from Marketing Authorisation Holders for the onward wholesale.