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Good manufacturing practice

Manufacture of Investigational Medicinal Products – Frequently Asked Questions

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accurately measuring ingredients into a petri dish

GMP and GCP Inspectors work closely with MHRA Clinical Trials and regularly provide support to help answer a wide range of stakeholder queries which relate to the manufacture, import, labelling, licencing requirements and general handling of Investigational Medicinal Products (IMPs). …

MHRA Process for approving Manufacturing Authorisations or API Registrations in relation to unlicensed Cannabis-Based Products for Medicinal Use

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Several companies have contacted the MHRA regarding cannabis-based products for medicinal use. This blog provides information on what authorisations are required in order to manufacture within this sector of the pharmaceutical industry. For an overview of unlicensed Cannabis-Based Products for …

New year, new standards for investigational medicines

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New GMP requirements from 31 January 2022 Monday 31 January 2022 saw the Clinical Trial regulation (CTR) come into force in the European Union, and with it, the Commission guidelines on good manufacturing practice for investigational medicinal products for human …

Global reflections on international inspection transformation: ICMRA remote inspections

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A link to the newly published ICMRA paper, which provides a valuable insight into how global regulators have managed regulatory oversight, inspections and assessments during the pandemic to support both the COVID-19 response, and also ‘business as usual’ GMP and GCP inspections.

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

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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.

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

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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.