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About Roquette Pharma

Roquette transforms three key crops into essential raw materials for the pharmaceutical and other industries. A large number of products are created from substrates made by Roquette to specific customer order: glucose and maltose syrups, dextrose and sorbitol help to produce vitamins; and starch, high DE glucose and maltose syrups, soluble maize extracts and concentrated protein isolates support the production of enzymes, organic acids and antibiotics.

For more information on Roquette log on to:
http://www.roquette-pharma.com.

 

 

About the GMP Audit

The re-audit was performed on 29 - 30 May 2008 at the Lestrem site, which not only reviewed the materials covered in the first two Audit Reports, but also looked at other materials. The initial Audit was performed on 27-28 May 2004, and covered five raw materials sold to the pharmaceutical industry. This Report combines the findings of three PharmAssess Audits that have been performed on this supplier, in May 2004, April 2006 and May 2008

The Audit Report provides information on the site facilities and covers the manufacture of Dextrose (LYCADEX ® PF / Dextrose Anhydrous PF), Mannitol (PEARLITOL® Pyrogen-Free), Sorbitol Powder (Pyrogen-free NEOSORB ®), Xylitol (Pyrogen-free XYLISORB ®), Xylitol  (XYLISORB ®), Glycolys®, Glucose Liquid, Neosorb® 70/20 B, Neosorb® 70/70, Neosorb® 70/70 B, Pearlitol® C, Sorbitol Powder Neosorb®, Lycasin® 80/55, Maize Starch B.

The Audit Report includes photographs and is 72 pages long, excluding appendices. Including appendices the Report is 110 pages long.

 


How to Purchase an Audit

There are just two steps to purchasing a conducted PharmAssess Audit Report:

  1. A Quotation will be sent to you, followed by a Service Agreement, on request, for the purchase of an Audit Report.
  2. Once we receive approval of the Quotation we will dispatch the Audit Report, accompanied by an Invoice.

Please note that if there are other audits that you are interested in, which are not noted in our GMP Audit Section of this website, please contact us to discuss your audit requirements, which we can arrange on your behalf.

 

Contact Us

If you require further information about the PharmAssess service offered by Rephine, or you would like to purchase an Audit Report today please contact Sonja Earl in our Commercial Department by:

Email: Use our contact form to email Sonja.


Telephone: + 44 (0) 1227 713 965
Fax: + 44 (0) 1227 713 450

PharmAssess GMP Audit Folder