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We’re Hiring - meet some of the Inspectors in Compliance Team 1

Posted by: , Posted on: - Categories: Compliance matters, Inside the Inspectorate, recruitment

We are currently recruiting for a Good Clinical Practice (GCP) Inspector and a Good Pharmacovigilance Practice (GPvP) Inspector in Compliance Team 1. We are passionate about reaching a diverse pool of candidates from a variety of backgrounds. In this blog …

ICH E6(R3) Good Clinical Practice guidance - Step 2 Public Consultation

Posted by: and , Posted on: - Categories: Good clinical practice, Uncategorized

The International Council for Harmonisation (ICH) Expert Working Group for ICH E6(R3) (EWG) has been updating the ICH E6(R2) Good Clinical Practice (GCP) guideline. The E6(R3) overarching principles, Annex 1, Glossary and 3 Appendices will replace the current E6(R2). These …

Manufacture of Investigational Medicinal Products – Frequently Asked Questions

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

Posted by: and , Posted on: - Categories: Good manufacturing practice

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 …