News Archive

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

19th August 2020

Graeme McKilligan 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. Requirements and expectations have been refreshed with Inspectors with a particular focus of attention on sites handling products with lower level Health Based Exposure Levels (HBELs), those with products around the red area of the continuum seen in the PIC/S Q&A document,

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OECD - Draft Guidance Documents on Good Laboratory Practice (GLP) for public comments

19th August 2020

On 07 August 2020, the OECD made OECD Draft Advisory Document on GLP Data Integrity for public comment.

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PIC/S publishes Aide-Memoire for the Inspection of Health Based Exposure Limit

19th August 2020

In June, the Pharmaceutical Inspection Convention/Cooperation Scheme (PIC/S) issued the new document PI 052-1. What is in it?

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Guidance for industry on MHRA’s expectations for return to UK on-site inspections

11th August 2020

The MHRA are planning to resume on-site UK risk-based GxP inspections in September.

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International Standard For Medical Device Testing Updated

4th August 2020

ISO 14155:2020 - Clinical investigation of medical devices for human subjects — GCP Patient safety is a key focus in update of ISO 14155, the industry reference for good practice in clinical trials.

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MHRA - GCP Serious Breaches update

4th August 2020

The annual metrics report for GCP referrals has now been published for 2019. In 2019, MHRA received a total of 112 serious breach notifications, of which: 75 were deemed to be a serious breach 36 deemed not to be a serious breach 1 awaiting further information to enable final determination...

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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 July 2020

29th July 2020

EMA’s human medicines committee (CHMP) recommended eleven medicines for approval at its July 2020 meeting, including a medicine for use in countries outside the European Union.

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RQA NEWS - GLP news pages updated

28th July 2020

The GLP News pages on the website have been updated today.

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EMA consultation: Concept paper for the development of a reflection paper on criteria for the application of Article 40(5) of Regulation (EU) 2019/6

23rd July 2020

The European Medicines Agency has published for public consultation for a concept paper for the development of a reflection paper on criteria for the application of Article 40(5) of Regulation (EU) 2019/6.

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

23rd July 2020

Starting in September, MHRA is making careful preparations for a safe return to normal UK on-site inspection scheduling.

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