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Good distribution practice

A fresh look at an old topic: Investigations in the GMDP environment

Posted by: , Posted on: - Categories: Compliance matters, Good distribution practice, Good manufacturing practice

Investigations are an inevitable aspect of any manufacturer’s or wholesaler’s operations. We share some common issues seen at inspections so you can consider your own company’s systems and practices and improve investigation outcomes.

MHRA planning for return to on-site Good Practice (GxP) inspections

Virus Particles

On 23rd March 2020 MHRA I published a post outlining changes to MHRA’s GxP inspection programme during the COVID19 outbreak. This enabled industry and the NHS to focus on medicine supply and delivery of healthcare in support of the COVID-19 pandemic

A Practical example of applying Quality Risk Management in GDP – Transportation Risks

Posted by: , Posted on: - Categories: Compliance matters, Good distribution practice
Scrabble pieces making up the word 'risk'.

Quality Risk Management (QRM) is a requirement of Good Distribution Practice (GDP). It underpins good design and maintenance of a GDP quality system and provides an approach that enables the quality system to be safe for patients, efficient and effective through identification of risks, and facilitates proportionality of mitigation.

How to manage temporary GDP process changes and risks through the COVID-19 pandemic

Posted by: , Posted on: - Categories: Compliance matters, Good distribution practice
Lady with a face mask and virus particles representing Covid infront of her

During the Covid-19 pandemic you may need to adjust how you operate. Such changes should be documented either as deviations, change controls or similar and incorporate quality risk management principles.

MHRA Good Practice (GxP) inspections during the COVID19 outbreak

Virus particle

The COVID19 pandemic presents an unprecedented challenge to healthcare, the pharmaceutical industry’s supply chain and personnel movement. MHRA understands the impact of its work on industry, NHS and patients.

Inspector Recruitment – Part Two

In part 1 of the inspectorate recruitment posts, we provided information on the inspector role and recruitment process, part 2 provides more information on the benefits and opportunities available to MHRA inspectors.

Inspector Recruitment -Part One

A plaque with the words 'Come in we're hiring'

Have you ever thought about becoming an MHRA inspector but wanted to know more about the role, the application process, or the benefits associated with joining a talented and dynamic team protecting public health? Part one of this two-part blog will hopefully give you the information you need to consider for applying for future roles.