16th March 2015
Data integrity is fundamental in a pharmaceutical quality system which ensures that medicines are of the required quality. This document provides MHRA guidance on GMP data integrity expectations for the pharmaceutical industry.
Use of Electronic Informed Consent in Clinical Investigations Questions and Answers Guidance for Industry
15th March 2015
DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.
3rd March 2015
New vacancy on the recruitment area of the RQA website - Vernalis are looking to recruit a Quality Assurance Associate, see website for further details
26th February 2015
Pfizer are looking for a Director, Inspection Manager. Details on our recruitment page.
25th February 2015
A new vacancy placed on our website, see our website for further details.
24th February 2015
CSL Behring are looking to recruit, see RQA recruitment page for further details.
27th January 2015
How to conform with the legal requirements for placing medical devices on the market.
26th January 2015
Information for manufacturers of medical devices about reporting adverse incidents and corrective actions to MHRA.
22nd January 2015
HRA and MHRA welcome public consultation on application of transparency rules of EU Clinical Trial Regulation
15th January 2015
New position posted on the Recruitment section of our website - Quality and Compliance Manager
13th January 2015
The RQA GCP Committee have found a number of out of date GCP documents on the new MHRA website - www.gov.uk. The MHRA have advised that some documents may not be up to date compared with the old site - www.MHRA.gov.uk. but the GCP Inspectorate will review the documents in the GCP areas over the next few weeks to ensure that they are up to date. Click on Read more to visit the old site
23rd December 2014
The new Clinical Trial Regulation (EU) No 536/2014 (hereinafter “the Regulation) establishes a harmonised approach to submission, assessment and reporting of clinical trials (CTs) with theimplementation of consistent rules throughout the Member States (MSs). These processes are to be supported by a EU portal and EU database which will ensure a centralised workflow with monitoring by the relevant parties.
17th December 2014
PSI are looking for a QA/GCP Auditor, further details below
EMA Classification and analysis good clinical practice (GCP) inspection findings of GCP inspections 01Dec2014 (Inspection reports to EMA (2000-2012)
12th December 2014
Classification and analysis of the good clinical practice (GCP) inspection findings of GCP inspections conducted at the request of the Committee for Medicinal Products for Human Use (CHMP)
10th December 2014
New recruitment opportunity on our website - see recruitment section for further details.
10th December 2014
Inspection Observations FDA’s Office of Regulatory Affairs (ORA) is the lead office for all field activities, including inspections and enforcement. During an inspection, ORA investigators may observe conditions they deem to be objectionable. These observations, are listed on an FDA Form 483 when, in an investigator’s judgment, the observed conditions or practices indicate that an FDA-regulated product may be in violation of FDA’s requirements.
5th December 2014
Celerion are looking for a QA Manager/Senior QA Auditor, details in recruitment section of our website.
2nd December 2014
The Department of Health (DH) reviews its arm's length bodies once every 3 years. This review is looking at what MHRA, the British Pharmacopeia and the Commission on Human Medicines do and how. DH has sent out a public call for evidence to support the reviews: Britsh Pharmacopeia Commission: triennial review Commission on Human Medicines: triennial review MHRA: triennial review
2nd December 2014
New vacancy placed on our website - MHRA - GLP Inspector
24th November 2014
In collaboration with a wide range of partners, the HRA has published a template and guidance for protocols for clinical trials of investigational medicinal products (CTIMPs). This is the first in a suite of templates for health research. The templates will be particularly valuable to new researchers, but the main aim is to provide clarity about the information that reviewers need to assess research projects, and that research teams need to conduct the project effectively.
24th November 2014
New investment into life sciences announced alongside a review into how we develop medicines and medical technology.
7th November 2014
New opportunity added to the website - GCP Quality Specialist - Imanova
3rd November 2014
A new recruitment opportunity has been added to the website. Associate Director, PPD
29th October 2014
Vacancy for Quality Assurance Manager, UCL Cancer Institute
22nd October 2014
Office of Pharmaceutical Quality officially launched. This is a new office within CDER that creates a single unit dedicated to product quality
16th October 2014
Senior QA Auditor - GCP - Global CRO
9th October 2014
Manager, Quality Assurance - Harlan
7th October 2014
The OECD working group on Good Laboratory Practice have published the advisory document Guidance on the GLP Requirements for Peer Review of Histopathology (external link) as part of the OECD Series on Principles of Good Laboratory Practice (GLP) and Compliance Monitoring.