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European Pharmaceutical Contractor

Commitment Issues

As with all regulations, some are easier to follow than others. There are always going to be scenarios ‘at the margins’ where any regulation will struggle to define the correct procedure or process for dealing with a specific issue, or may appear to be in conflict with some other aspect of best practice.

This has been amply illustrated within the laboratory sector in recent times, with the delayed implementation of General Chapter <467> Residual Solvents of the United States Pharmacopoeia – National Formulary (USP-NF). This proposed revision to the USP-NF had first been scheduled for introduction on 1st January 2007, only for implementation to be delayed until 1st July 2007, and then further delayed with an implementation date of 1st July 2008.

BACKGROUND TO CHAPTER <467>

The essential rationale behind USP <467> is an attempt to harmonise test standards for residual solvents for medicines sold in the US in accordance with a model already adopted by the European Pharmacopeia. It aims to prescribe standard test methods for three classes of solvent. These are:

  • Class 1 solvents, a defined list of chemicals that are known or suspected to be human carcinogens
  • Class 2 solvents, a defined list known to be animal carcinogens or to exhibit other toxicity
  • Class 3 solvents, a defined list of chemicals having low toxic potential

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Philip Payne is Business Development Manager for RSSL Pharma. He joined from Italian API producer, Steroid, where he was General Manager with responsibility for sales, procurement, production and analysis. Fluent in Italian, French and English, and with broad experience of research and production, Philip now assists RSSL Pharma in promoting its analytical and training services more widely across Europe, in addition to the UK and Ireland.
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