Journal of Developing Drugs
Open Access

A risk based scientific approach to analytical method development and validation activities for regulated laboratories

2^nd International Summit on GMP, GCP & Quality Control

November 12-14, 2013 DoubleTree by Hilton Hotel Chicago-North Shore, IL, USA

Shib Mookhaerjea

Scientific Tracks Abstracts: J Develop Drugs

Abstract :

Key Topics ? An overview of global compliance issues, global harmonization initiatives, role of ICH, relevance of Validation activities & the Paradigm Shift ? Quality Control and Quality Assurance in analytical, R&D, QC, PD laboratories: General considerations, quality systems, QC procedures, QA oversight, process control measure. ? Perspectives of ICH ISO integration: ICH Q1 (stability studies), Q2 (Analytical Methods), Q3 (Impurities), Q7 (Pharma Process), Q9 (Risk Assessment), Q10 (Quality Systems), etc. ? Measurement, measurement uncertainty, measurement resolution, total error, and bias ? Analytical measurement: Process Model & Risk Assessment (REMS) ? A generic, science based outline of Methods Development & Validation [ab initio] ? Perspectives of QbD, PAT Directives: On-Line Measurements vs. Off-Line ? Validation parameters, their generic definitions, and their practical applications to various methods ? Highlights of the guidelines derived from International standards - ISO 17025, AOAC, WHO, GLP, GMP, EMEA, USP/EP/ JP, etc. ? Standardization/qualification/verification/validation: The implicit continuum ? A generic approach to analytical method optimization during development ? Some case histories and applications for improvement of validation characteristics ? Data integrity and statistical evaluation of analytical data: SQC, control charts ? Methods development and optimization in HPLC, UV-VIS including assessment of peak purity, as examples of the most recent techniques widely used in analytical laboratories ? Methods validation & regulatory submissions: IND/ ANDA/ NDA/ CMC ? Method development and validation by examples (group exercise): How to systematically develop and validate an assay for a trace component in a very complex sample matrix, develop the schematic template of a validation protocol ? Perspectives of qualification of various analytical systems (IQ, OQ, PQ) GAMP, USP