Ph. Eur. and USP changes – what every UV/Vis lab should know
ABOUT THIS WEBINAR
Pharmacopeias are published by regulatory bodies and define guidelines on the procedures and analytical instrumentation for the preparation and analytical measurement of pharmaceutical products. Both the American and European Pharmacopoeias, USP and Ph. Eur. respectively, have a dedicated chapter on the requirements of UV/Vis spectrophotometers and the verification of their performance. Pharmaceutical companies are facing the challenge of adapting their workflow to Pharmacopoeia regulation revisions that become mandatory at the end of 2019. METTLER TOLEDO has adapted the automated performance verification accessories so that the compliance of all customers is maintained.
This webinar provides an overview of the important UV/Vis spectroscopy-relevant changes in both USP and Ph. Eur., taking a closer look at their impact and the solutions available to ensure compliance.
The verification of photometric linearity has not been mandatory until this latest revision; this test is now explicitly defined in both USP 42-NF37 2nd supp. and Ph. Eur. 10. Other parameters that can be tested, but are not required by regulation, are photometric noise, photometric drift and baseline flatness. These parameters are assessed by performing spectroscopic measurements using different liquid or solid filters, depending on the test.
As the procedure for comprehensive performance verification is intricate and time consuming, there are great benefits of integrating it into the analytical workflow and having automatic execution.
In the second section of this webinar, the positive impact of automation on workflow efficiency and security in optical performance verification of UV/Vis spectrophotometers with certified liquid reference materials will be assessed against manual execution. Furthermore, the importance of automatic data integrity compliant management of certification data will be emphasised as an important parameter for regulation compliant documentation.
Learning outcomes of this webinar:
- Know the changes in the respective optical chapters of USP 42 – NF37 2nd and Ph. Eur. 10
- Know the consequences on optical performance verification of UV/Vis spectrophotometers
- Benefits of automated performance verification
- Positive aspects of usage of certified liquid reference materials
- Data integrity compliance in optical instrument qualification.
Dr Hans-Joachim Muhr, Head of Strategic Product Group UV/VIS, Mettler-Toledo GmbH
Dr Hans-Joachim Muhr, PhD has 16 years of experience in project innovation management, global sales and marketing for titration automation products as well as seven years of executive management responsibility in analytical instrument businesses (UV/Vis, Thermal Values).