alexa Analytical Test Method Validation (AMV) Of Finished Pharmaceutical Products (FPP) & System Suitability Requirements
ISSN: 2167-7689

Pharmaceutical Regulatory Affairs: Open Access
Open Access

OMICS International organises 3000+ Global Conferenceseries Events every year across USA, Europe & Asia with support from 1000 more scientific Societies and Publishes 700+ Open Access Journals which contains over 50000 eminent personalities, reputed scientists as editorial board members.

Open Access Journals gaining more Readers and Citations

700 Journals and 15,000,000 Readers Each Journal is getting 25,000+ Readers

This Readership is 10 times more when compared to other Subscription Journals (Source: Google Analytics)

Share This Page

Additional Info

Loading
Loading Please wait..
 

3rd International Conference on Pharmaceutical Regulatory Affairs
October 21-23, 2013 DoubleTree by Hilton Hotel San Francisco Airport, CA, USA

Rober Remon Saad Habashy
ScientificTracks Abstracts: Pharmaceut Reg Affairs
DOI: 10.4172/2167-7689.S1.010
Abstract
The Objective of Validation of an Analytical procedure is to demonstrate that it is suitable for its intended purpose. It is applicable to identification, Control of Impurities and Assay. Analytical Test Method Validation for Dissolution Method follows almost the same procedure but only differs in the Acceptance criteria. Analytical Test Method Validation Scheme discusses requirements to be done after Analytical test Method Development. The discussion will only cover Analytical Test Method Validation of Analytical procedures for the Assay of the active pharmaceutical ingredient (API), content of impurities and Acceptance criteria According to ICH Q2B, USP/FDA Guidance for Industry document for analytical test method validation, EP/BP, JP&WHO. It will mainly cover HPLC Method Validation and its System Suitability Criteria. This discussion is required for registration in, or export to the mentioned countries that follow such Guidance(s) as part of the CTD Quality module. The Discussion will also cover the difference between Analytical Method Validation and Analytical method verification for Compendial Procedures.
Biography
Rober Remon Saad Habashy has completed his Bachelor degree in pharmaceutical science 2007 at the age of 22 from Misr International University School of Pharmacy. He completed his Total Quality Management (TQM) Diploma from the American University in Cairo 2009. He became certified Six Sigma Black Belt (CSSBB) from the American Society for Quality (ASQ) October 2011 as well as Diploma in Quality Assurance in the same year from the American supplier institute (ASI). He is the Training Chair at the American Society for Quality Local Member Community (LMC) in Egypt. He is a core member senior Research & Development pharmacist at Amoun Pharmaceutical Company Cairo Egypt. He works at the R&D Department and responsible for Analytical test method development and Validation as well as formulation and pre-formulation studies, Product / process design for human/vet Pharmaceutical product.
image PDF   |   image HTML
 

Relevant Topics

Peer Reviewed Journals
 
Make the best use of Scientific Research and information from our 700 + peer reviewed, Open Access Journals
International Conferences 2017-18
 
Meet Inspiring Speakers and Experts at our 3000+ Global Annual Meetings

Contact Us

 
© 2008-2017 OMICS International - Open Access Publisher. Best viewed in Mozilla Firefox | Google Chrome | Above IE 7.0 version
adwords