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GMP issues with the contract manufacturer Ben Venue Laboratories (BVL), Ohio, USA: Effects on clinical trials of medicinal products

Effects on clinical trials with medicinal products containing one of the following active ingredients:

  • anidulafungin
  • PEG-L-asparaginase
  • azacitidine
  • aztreonam
  • bivalirudin
  • bortezomib
  • busulfan
  • carmustine
  • cidofovir
  • eculizumab
  • histamin hydrochloride
  • mifamurtide
  • liposomal doxorubicin
  • hexaminolaevuniate
  • oxaliplatin
  • perflutren
  • raltitrexed
  • ribavirin
  • romidepsin
  • temsirolimus
  • telavancin
  • tetrakis (2-methoxy isobutyl isonitrile) copper (I) tetrafluoroborate
Date 2011.12.02

With reference to the statements released by the European Medicines Agency (EMA)

European Medicines Agency gives interim recommendations to deal with shortcomings in quality assurance at Ben Venue Laboratories

and the BfArM

GMP shortcomings at Ben Venue Laboratories

the BfArM calls attention to the fact that clinical trials with medicinal products containing the a.m. active ingredients can also be affected by these GMP shortcomings.
Pursuant to Article 13 sub-section 3 of Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 each production batch of an investigational medicinal product must be manufactured in accordance with standards of good manufacturing practice (GMP). This is to be assured by the sponsor of the clinical trial. Batches of medicinal products which contain the a.m. active ingredients and are being recalled from the market must not be used in clinical trials anymore and are to be replaced. Sponsors of clinical trials with medicinal products containing these active ingredients are advised to contact relevant sources for information as to corresponding batch recalls.

Should such batches currently be used in clinical trials, the competent federal authority is to be informed immediately in accordance with Section 13 sub-section 4 of the GCP Ordinance (GCP-V).