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Reviewing the 2014 FDA CDER/CBER Draft Guidance: Analytical Procedures and Methods Validation for Drugs and Biologics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

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