Elemental Impurities According to the new ICH Q3D and USP 232/233 Guidelines

Sept. 4, 2013 - PRLog -- Why to attend:

ICH has officially released Draft 2 of the ICH Q3D guideline on elemental impurities. According to ICH this new guidance will provide a global policy for limiting metal impurities qualitatively and quantitatively in drug products and ingredients. Pharmaceutical and API industry will have to implement the guideline once final. The guide proposes elements and limits and controls to reduce the impurities to below the limits. USP 232 also lists elements and limits that are quite similar to ICH and are expected to be harmonized with ICH. In addition to USP 232 requirements ICH also suggests risk based control strategies to reduce the impurities to below the limits. This seminar will help pharmaceutical and API industry to control impurities according ICH and to analyze them according to USP 233.

Areas Covered in the Seminar:

* FDA and equivalent international requirements
* Background of elemental impurity guidelines
* The approaches of the ICH Q3D and guidelines
* Scope of the guidances: what needs to be controlled
* Principles of safety assessment of potential impurities
* Elements and limits for drugs and drug substances
* ICH Q3D classification for elemental impurities
* Permitted daily exposure (PDE) for different routes of administration
* Options to calculate concentration limits from PDE
* Justification for Impurity levels higher than the PDE
* Risk based control of elemental impurities: initial and on-going
* Similarity and difference between ICH Q3D and USP <232>
* ICH/USP recommendations for analytical procedures and equipment

And for easy and instant implementation:
download 10+ documents from special seminar website.
They include

* PowerPoint Presentation
* Script
* 43-page Primer: Elemental Impurity Analysis In Regulated Pharmaceutical Laboratories
* SOP: Control of Elemental Impurities according to ICH Q3D
* SOP: Validation of Analytical Methods for Elemental Impurities
* Checklist: Elemental Impurity Analysis According to USP 233
* Checklist: Control of Elemental Imurities according to ICH

Date:  October 17, 2013
Time: 11.00 - 12.00 a.m. ET
Location: Online, worldwide

Category: Pharmaceutical, GMP, API Manufactuer, FDA, Training

Who should attend
* Pharmaceutical and API industry
* Laboratory managers and staff
* Analysts
* QA managers and personnel
* Regulatory affairs
* Training departments
* Documentation department
* Consultants


Weblink:  http://www.labcompliance.com/seminars/audio/324/default.aspx

Category: Pharmaceutical, GMP, API Manufactuer, FDA, Training

Presenter: Dr. Ludwig Huber

Ludwig Huber, Ph.D., is Director for global FDA compliance at Labcompliance. He is the author and editor of www.labcompliance.com, the global on-line resource for validation and (laboratory) compliance. Dr. Huber has been presenting more than 200 web, video and audio seminars. and he has given multiple presentations and workshops mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This included workshops and presentations for the  US FDA, ISPE, PDA, PDA, PIC/S and several national health agencies including China SFDA