Sharing experience from recent events to help you safeguard the legitimate supply chain and avoid risks to public health
Good distribution practice
The definition of a falsified medicine and how to check that your systems comply
Maintaining compliance in a changing world and the complementary themes of change management and control ran throughout the various sessions at this event.
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.
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.
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.
Implementation of the FMD safety features in the UK
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.
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
The Process Licensing Office has today joined the Inspectorate to become the Inspectorate & Process Licensing Group.