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Good distribution practice

Too good to be true? How to play your part in protecting the UK medicines supply chain (updated)

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The MHRA is inviting you to attend a free webinar as part of its commitment to providing guidance to industry and supporting stakeholders to prevent falsified medicines entering the legal supply chain.

Inspectors grounded - a year of innovation

The start of lockdown this time last year meant a complete change to the way of working for the inspectorate, with the potential to impact dramatically on our ability to maintain regulatory oversight of public health

Qualifications of suppliers and customers online: reliable or fake news?

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The need for vigilance and diligence when conducting bona fide checks is integral to protecting the legal supply chain of medicines. What to look out for and how to report any suspected fraudulent activity

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

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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

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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

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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.