MTS Recommends... Best Practices in Analytical Method Development and Testing

Best Practices in Analytical Method Development and Testing

By Mario DiPaola in Pharmaceutical Technology, Volume 2018 eBook, Issue 2, pg 16–23, Nov 15, 2018

This article discusses why it is important to apply risk analysis, QbD, and DoE in the development of analytical methods.

Click here to read the article

MTS Recommends... Mixing and Mixers in Liquid Chromatography—Why, When, and How Much? Part 1, The Pump

Mixing and Mixers in Liquid Chromatography—Why, When, and How Much? Part 1, The Pump

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.
 
Click here to access the article.

Update of ICH Q2 'Validation of Analytical Procedures' Announced

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.

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MTS Recommends... Data Integrity in the GxP Chromatography Laboratory, Part III

Data Integrity in the GxP Chromatography Laboratory, Part III: Integration and Interpretation of Data

By Mark E. Newton, R.D. McDowall
LCGC North America, May 01, 2018, Volume 36, Issue 5, pg 330–335

MTS Recommends... Data Integrity in the GxP Chromatography Laboratory, Part II

Data Integrity in the GxP Chromatography Laboratory, Part II: Setting up a Chromatograph and Acquiring Data

By Mark E. Newton, R.D. McDowall
LCGC North America, Apr 01, 2018, Volume 36, Issue 4, pg 270–274

MTS Recommends... Data Integrity in the GxP Chromatography Laboratory, Part I

Data Integrity in the GxP Chromatography Laboratory, Part I: Sampling and Sample Preparation

By Mark E. Newton, R.D. McDowall
LCGC North America, Jan 01, 2018, Volume 36, Issue 1, pg 46–51

MTS Recommends... What's New In MHRA's Revised Data Integrity Guidance — A Detailed Analysis

What's New In MHRA's Revised Data Integrity Guidance — A Detailed Analysis 

A very detailed summary of all the changes in this guidance from the original GMP guidance issued in 2015, and the draft GxP version released in 2016.

By Barbara Unger
Pharmaceutical Online, March 19, 2018

MTS Recommends... Method Transfer Video

In this great video from Waters, the importance of getting method transfer right, and the consequences of getting it wrong, are highlighted.

Guidance on GxP Data Integrity from MHRA Finalised

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 practice).

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.

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Visit Dublin City for an MTS Course!

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.

Read more about things to do in Dublin on VisitDublin.com, Dublin’s official tourism information website.

MTS Website Revamp

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.

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MTS Recommends... Methods for Identifying Out-of-Trend Data in Analysis of Stability Measurements—Part II: By-Time-Point and Multivariate Control Chart

Methods for Identifying Out-of-Trend Data in Analysis of Stability Measurements—Part II: By-Time-Point and Multivariate Control Chart 

 "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.

MTS Recommends... Methods for Identifying Out-of-Trend Data in Analysis of Stability Measurements–Part I: Regression Control Chart

Methods for Identifying Out-of-Trend Data in Analysis of Stability Measurements–Part I: Regression Control Chart 

"In Part I of this article series, the regression control chart method for identifying out-of-trend data in pharmaceutical stability studies is investigated, and an improved approach is suggested."

M. Mihalovits and S. Kemény, "Methods for Identifying Out-of-Trend Data in Analysis of Stability Measurements–Part I: Regression Control Chart," Pharmaceutical Technology 41 (11) 2017.

MTS Recommends... Data Integrity Metrics for Chromatography

Data Integrity Metrics for Chromatography

Dec 01, 2017
By Mark E. Newton, R.D. McDowall
LCGC Europe
Volume 30, Issue 12, pg 679–685

"The authors discuss metrics for monitoring data integrity within a chromatography laboratory, from the regulatory requirements to practical implementation."