Cookie policy: This site uses cookies (small files stored on your computer) to simplify and improve your experience of this website. Cookies are small text files stored on the device you are using to access this website. For more information please take a look at our terms and conditions. Some parts of the site may not work properly if you choose not to accept cookies.


Subscribe or Register

Existing user? Login

Drug manufacturing

‘Sterility’ problems at Moorfields raised by regulator

The manufacturing arm of the world-renowned Moorfields Eye Hospital has failed to meet production standards.

Eye drop

Serious deficiencies in sterility and sterilisation processes were found at the manufacturer of ophthalmic products

The manufacturing arm of the world-renowned Moorfields Eye Hospital, which produces more than 100 unlicensed medicines and licensed branded products, has failed to meet production standards.

During a visit to Moorfields Pharmaceuticals’ London site in May 2014, inspectors from the UK medicines regulator identified “serious deficiencies” in sterility and sterilisation processes that break good manufacturing practice (GMP) standards.

But the Medicines and Healthcare products Regulatory Agency (MHRA) said that patients were not at risk and did not close the site or issue any product recalls. It said medicines produced by Moorfields Pharmaceuticals should continue to be taken as recommended.

According to information published on the online European database of GMP certificates, which is maintained by the European Medicines Agency, its ‘pharmaceutical quality system’ also fell short of expected standards. The website says that the breaches were associated with “primarily unlicensed medicines made for specific named patients or for small hospital orders”.

“A number of products have been deemed medically critical by the UK and non-critical products within shelf life were recalled from hospitals within the UK by Moorfields Pharmaceuticals.

“The supply of products not deemed medically critical has been suspended. Critical products … should continue to be supplied,” it says.

The MHRA confirmed that it had issued Moorfields Pharmaceuticals with a GMP non-compliance statement and says it is working with the Department of Health to ensure that the production of medicines needed by UK patients continues.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2014.20065480

Have your say

For commenting, please login or register as a user and agree to our Community Guidelines. You will be re-directed back to this page where you will have the ability to comment.

Recommended from Pharmaceutical Press

Search an extensive range of the world’s most trusted resources

Powered by MedicinesComplete
  • Print
  • Share
  • Comment
  • Save
  • Print Friendly Version of this pagePrint Get a PDF version of this webpagePDF

Newsletter Sign-up

Want to keep up with the latest news, comment and CPD articles in pharmacy and science? Subscribe to our free alerts.