• gmp-verlag.de
  • GMP MANUAL Login
  • Shopping cart
Stay informed!

You’d like to be regularly informed on the latest developments in Good Manufacturing Practices?

 

Subscribe to our free GMP Newsletter LOGFILE!

>>> REGISTER NOW

The New USP <1231>
Water for Pharmaceutical Purposes

a detailed Overview

>>> ORDER NOW

Award for the
GMP Compliance Adviser

GMP knowledge that convinces.

Image

On 7 June 2016 Maas & Peither GMP Publishing has received a

SIPAward in the category
"Best New Success Story" and was awarded with the 3rd place.

The GMP MANUAL (now: GMP Compliance Adviser) impressed the jury with "Safe Drugs through Better GMP Understanding".


GMP Compliance Adviser

GMP in Practice: 24 chapters written by internationally renowned industry experts.

 

GMP Regulations: 8 chapters with the most important GMP guidelines and regulations.

 

Image

>>> READ MORE

TOP 5 GMP Downloads

1. Questionnaire for preparing GMP-inspections
More than 650 typical questions related to audits and inspections.


2. GDP Audit Checklist
More than 700 questions with reference to regulations.


3. GMP Fundamentals
A quick and comprehensive overview of the complex world of GMP.


4. Industry Guide to handle OOX Test Results
Every single step of the OOX process.


5. The New USP <1231>: Water for Pharmaceutical Purposes
A compact overview of the contents of the new version of USP <1231>.


>>> More Downloads

News about GMP/cGMP

2017-06-20

Counterfeit Harvoni® Entered German Supply Chain

According to a press release by the BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte, the German Federal Institute for Drugs and Medical Devices), a counterfeit pack of Gilead Sciences’ hepatitis C drug Harvoni® has entered the legal supply chain in Germany. The “falsified medicinal product” was identified by a patient who noticed a change in colour which was orange instead of white.

 

The packaging, batch number, tablet form and embossing matched exactly the genuine packets.

On June 6, 2017, Gilead Sciences has recalled the batch and further investigated the issue. On June 14, the results of laboratory analysis of Harvoni® 90 mg / 400 mg tablets (Batch 16SFC021D) were available and showed that the product was identical with the original product for the European market, except for the colour. Furthermore, it turned out that the product was not intended for the EU market but as access market product. It is more than likely that the product was repackaged, relabeled and is therefore considered a counterfeit product.

The emergence of counterfeit Harvoni® in Germany follows reports of fakes in other countries in 2016. Over the past 18 months, regulators in Israel, Japan and Switzerland have discovered batches of fake Harvoni®.  The plastic bottles found in Switzerland originate in India and were imported by a Swiss trading company. The tablets found in Switzerland, like those discovered in Germany, were white.

Batches discovered in Japan were more diverse. Some tablets were purple. Others were more oval in shape than the diamond-shaped tablets manufactured by Gilead. It is advised not to purchase the medicine from unknown sources or via the Internet.

The BfArM Germany is working closely with national authorities, with the European Medicines Agency EMA and with other European authorities to establish whether Harvoni® packets with counterfeit contents have been imported to other countries in Europe.

Source:

BfArM Press Release (in German)

Raps: News

Comments
No comment has yet been written about this news.
 
 
Literature recommendation
GMP Compliance Adviser
Single User Licence (yearly subscription)