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Good manufacturing practice

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

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.

Cross Contamination Control in Shared Facilities and Equipment. Reflection on common deficiencies and expectations as seen in recent PIC/S guidance.

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

During this period where MHRA has been conducting predominantly remote inspections, we have reflected on some of the common factors in critical deficiencies we have been seeing in control strategies for cross contamination between products in shared facilities.

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

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.

Maintaining control: Remote working and QP certification

Posted by: , Posted on: - Categories: Compliance matters, Good manufacturing practice
Laptop, papers, phone and a cup of coffee at a desk

In the modern world it is increasingly common to see flexible, part-time or home working arrangements. The pharmaceutical industry is no exception, and with some companies employing a part-time or contract Qualified Person (QP), it is no surprise that the QP continues to play a key role even when away from the site.

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.