What do you need to know about European Pharmacopoeia compliance?

Thermo Fisher Scientific looks at the key points  for compliance…

Are you ready for EP compliance?

The use of handheld Raman for the identification of raw materials has become increasingly prevalent in the pharmaceutical industry over the past five years, resulting in a need for definitive performance criteria for handheld Raman spectrometers. In response to an obvious need for specifications that can ensure reliable verification and the safe manufacture of medicines, the European Pharmacopoeia (EP) is introducing new standards for benchtop and handheld Raman analysers this year.

European Pharmacopoeia Supplement 8.7

In October 2015, the European Pharmacopoeia Supplement 8.7 was published, including a revision to Chapter 2.2.48:  Raman Spectroscopy.  This supplement will be effective on April 1, 2016.  Of particular note, the revised chapter includes separate acceptable Raman shift band position tolerances for benchtop and handheld Raman analysers for polystyrene, paracetamol and cyclohexane.

EP changes impact pharmaceutical manufacturers

For the first time, the European Pharamcopoeia has established specific wavenumber accuracy requirements for handheld Raman spectrometers. These new specifications give pharmaceutical manufacturers clear guidance on the requirements for use in GMP environments. Manufacturers will now have well-defined parameters without the need to justify analytical performance individually. Overall, these changes should streamline the deployment of handheld solutions for the release of raw materials.

History of industry-leading performance

The Thermo Scientific TruScan family of instruments boasts over 1000 GMP installations worldwide since its introduction in 2008. These handheld analysers are used at leading pharmaceutical companies to ensure the efficient release of raw materials and to screen for falsified or substandard medicines.  TruScan’s patented chemometric algorithm, in conjunction with superior spectrometer stability, allows sharing across large numbers of instruments without the need to establish a spectral library for each instrument.  TruScan analysers are designed to be used in GMP raw materials identification (RMID) testing without the need for recalibration. They do not require any user calibration and their laser and spectrometer stability is designed to eliminate the need to update the analyser’s hardware or manufacturing operations to ensure compliance. 

In anticipation of the new requirements, Thermo Fisher Scientific has adjusted all validation procedures and acceptance criteria for initial instrument calibration as well as annual calibration re-certifications. The company says it is closely monitoring regulatory expectations to best meet customer requirements going forward.