Re-developing, Validating and Licensing Alternative Analytical Methods
With the current shortage of Acetonitrile showing no abatement, many companies are now considering re-developing and validating HPLC methods that use an alternative solvent.
If you are considering making changes to methods, either licensed or pharmacopoeia monograph procedures, we at Butterworth would be very pleased to assist you with this process.
Outsourcing the Development and Validation process could well be cost-effective and would enable your Quality Control laboratory to concentrate on your core business, until new methods have been formally approved.
The MHRA website was recently updated and now provides information on this subject (See Link: http://www.mhra.gov.uk/Howweregulate/Medicines/Medicinesregulatorynews/CON036276). A recent communication to us from the MHRA (see over) has highlighted what is expected of Contract Laboratories. In order that Butterworth can ensure compliance to GMP and any marketing authorisations for the relevant finished products, this process of re-developing and validating methods must be formally documented. We would than have evidence of due diligence for any Regulatory Inspections.
Some clients are considering validating and licencing an alternative method purely as a precautionary exercise, in case the current situation last longer and supplies more difficult than currently anticipated.
For more information on this and other services Butterworth can offer, please contact our Scientific Business Manager, John Welch, either by e-mail or telephone.
We can also assure you that Butterworth laboratories have taken steps to secure adequate supplies of Acetonitrile for the foreseeable future.
For more information on this, or if you have any general questions or enquiries please don't hesitate to get in touch.