GOV.UK
The 2018 Good Distribution Practice (GDP) Symposium
Maintaining compliance in a changing world and the complementary themes of change management and control ran throughout the various sessions at this event.
Good distribution practice
PIC/S Meetings April 2019
From 8 to 10 April 2019, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) Committee and PIC/S Executive Bureau meetings took place in Geneva, Switzerland.
What does qualification of suppliers mean to you? Risks to patients and to your business
Recent cases of criminal attempts to sell falsified and stolen stock into the legitimate supply chain have exposed weaknesses in some supplier qualification processes. A reminder of what companies need to do to protect themselves, the public and the supply chain.
Introducing the GDP Office Based Evaluation and Risk Assessment programme (OBERA)
Gateway inspections are due to commence spring 2019 as the first stage of a new GDP inspection approach which will allow MHRA to increase its level of oversight whilst reducing the regulatory burden on those companies with a large number of sites which perform reduced or limited levels of GDP activity.
Falsified Medicines Directive: Safety Features
Implementation of the FMD safety features in the 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.
The Responsible Person named on the WDA- Part 3: Expectations for the engagement of consultants as contract RPs
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
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
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
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.