By Dwight R. Stoll in LCGC Europe, Volume 31, Issue 10, pg 558–563, Oct 01, 2018
This an excellent, very detailed account of how different pumps works and associated issues that I think would be very helpful for anyone who is trying to get a better understanding of practical issues relating to operating and troubleshooting HPLC.
At the ICH meeting in Kobe, Japan in June it was decided that the ICH guidance, 'Q2(R1): Validation of Analytical Procedures: Text and Methodology' would be revised and that an additional guidance, Q14, would be prepared on the topic of Analytical Procedure Development. Since the method validation guidance dates back to 1996, it is good news that an update is in the pipeline although it may be some time before the new version is ready. It will also be very interesting to see what the new method development guidance suggests.
The GxP Data Integrity guidance from MHRA has now been finalised.
From the MHRA Website:
"The guidance is intended to be a useful resource on the core elements
of a compliant data governance system across all GxP sectors (good
laboratory practice, good clinical practice, good manufacturing
practice, good distribution practice and good pharmacovigilance
It addresses fundamental failures identified by MHRA and international regulatory partners during GLP, GCP, GMP and GDP inspections; many of which have resulted in regulatory action."
If you need help on evaluating or improving data integrity in your laboratory then MTS can help. We offer auditing services to identify your data integrity issues, consultancy advice on how to assess data integrity risk, perform a gap analysis and implement remediation measures, and customised training courses to inform your staff about data integrity principles and problems so that they are fully engaged with your data governance systems.
Contact us to find out more about how MTS can help you with your data integrity requirements.
Read more about the new guidance on the MHRA website. Click here for the finalised MHRA guidance.
Dublin is a great location for our training courses, it allows you to experience a very special city. Our venue is located close to Dublin Airport which makes it easy to get to but also has great transport links into the city centre.
The MTS website has been revamped to make it easier for our visitors to quickly find the information that they need. We've also added links to the website menu on the MTS blog. Visit the website now to find out about the training, consultancy and auditing services that we can offer.
"In Part I of this article series, the authors discussed the regression control chart method for identifying out-of-trend data in pharmaceutical stability studies. In Part II, the by-time-point method and the multivariate control chart method are investigated, and improved approaches are suggested. The method is illustrated using real data sets."
M. Mihalovits and S. Kemény, "Methods for Identifying Out-of-Trend Data
in Analysis of Stability Measurements–Part II: By-Time-Point and
Multivariate Control Chart," Pharmaceutical Technology 41 (12) 2017.
Hi. My name is Oona McPolin and my company is called Mourne Training Services Ltd. I am a trainer, consultant and auditor specialising in chemical analysis of pharmaceuticals and biopharmaceuticals. This blog has now retired. You can visit the new blog on the MTS website