MTS Recommends... Moving On to Implementation for Elemental Impurities Testing

Moving On to Implementation for Elemental Impurities Testing
Pharmaceutical Technology Outsourcing Resources Supplement 39 (17) 2015.

"After a long wait for the new elemental impurities guidelines, the bio/pharma industry must now look ahead to implementation and take action."

MTS Recommends... A Risk-Based Approach to Data Integrity

A Risk-Based Approach to Data Integrity 
By Kurt In Albon, Daniel Davis, PhD, James L. Brooks, Pharmaceutical Technology, Volume 39, Issue 7, pg 46–50, Jul 02, 2015

"Heightened regulatory scrutiny of data integrity highlights the need for comprehensive procedural reviews and strategies for managing mission-critical information."

New Guidance for Industry from FDA: Analytical Procedures and Methods Validation for Drugs and Biologics

The FDA has issued a new guidance for Industry: Analytical Procedures and Methods Validation for Drugs and Biologics, July 2015. This guidance was previously reviewed on the MTS blog when it was first published as a draft in early 2014 and there are no major changes from the draft version.

I will be presenting a lecture on this new guidance at the upcoming conference, 'Analytical Method Development, Validation and Transfer', on the 15th September at the Maritim proArte Berlin, Germany. The overview of the presentation is as follows:

Reviewing the 2014 FDA CDER/CBER Draft Guidance: Analytical Procedures and Methods Validation for Drugs and Biologics

• Overview of the guidance including key recommendations and impact on industry
• Exploring recommendations for lifecycle management including revalidations and comparability studies

I'll post a summary of the lecture here on the MTS blog after the event.

  Tweet

Update to MTS Course Calendar 2015

The MTS Course calendar for 2015 has been updated to include our new courses on Laboratory Data Integrity. Check out the new calendar for open enrolment dates in 2015 at locations in the UK, Ireland and Germany for this new event!

  Tweet

New Training Course: Laboratory Data Integrity

MTS is offering a new training course on the topic of Laboratory Data Integrity. The course is made up of three days, you can attend any preferred combination of days:

1: Introduction to Laboratory Data Integrity; cGMP in the Pharma Lab
Day 1 introduces the fundamental concepts of laboratory data integrity in the context of working within a quality management system and as such this course also acts as an introduction/refresher to laboratory cGMP.

2: Applying Data Integrity in the Laboratory; Minimising Analytical Error
Day 2 deals with the effects of analytical errors on laboratory data integrity. This involves building an understanding of the nature and sources of analytical errors so that their effects can be minimised during testing, leading to high standards of data integrity and reduced numbers of OOS/OOE results due to laboratory errors.

3: How to Improve Data Integrity in the Pharma Lab
Day 3 focusses on improving laboratory data integrity and associated quality management systems by review of laboratory processes to identify data integrity risk, and implementation of appropriate solutions, paying particular attention to deficiencies that are commonly cited by regulatory authorities.

Visit the MTS website for more information and details of the open enrolment dates and locations.

  Tweet

MTS Recommends... Questions of Quality: Where Can I Draw The Line?

Questions of Quality: Where Can I Draw The Line?

By R.D. McDowall
LCGC Europe
Volume 28, Issue 6
Jun 10, 2015

"A question that keeps raising its head when working in a regulated laboratory is can chromatographers integrate peaks manually? If they can, when can they do it? Also if they can manually integrate, when should they not do it?"