GOV.UK
Digital Health and Pharma 4.0
The GXP environment is evolving as digital technologies are increasingly being applied to the development and manufacture of medicines.
Good distribution practice
Good Manufacturing Practice/Good Distribution Practice Symposium 2019
The MHRA Good Manufacturing/Good Distribution Practice Symposium will be held in London on the 11 to 14 November and in Glasgow on 26 to 27 November 2019. This post details how to secure your place and provides some information about what each of the sessions will include.
MHRA Process Licensing: useful information
Details and links for new licence applications and variations.
Supply chain security: part 1 - introduction
Theft of medicines increases risk to public health - a look at what can be done to improve distribution security standards.
Falsified Medicines and the supply chain
Sharing experience from recent events to help you safeguard the legitimate supply chain and avoid risks to public health
How the implementation of Safety Features progresses 5 months in
The definition of a falsified medicine and how to check that your systems comply
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.
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.