Pharmacopiea PowerPoint PPT Presentations

Definition for Reference standard Requirements Guidelines Pharmacopiea Types of Reference Standards GMP- ICH Q7 SOP for handling of Reference Standards Qualification of Secondary Standards Assigning Potency, Storage and Use Documents & Records

Definition Requirements QC Lab Management Documents & Records QC personal Sample Management Reagents & Reference standard Instruments and Calibration Computer System Validation Analytical method Analysis, analytical data & Review Reserve sample Purposes of GMP Documentation Tips to good documentation practices Warning letters and observations

Introduction Solvents & Reagent Quality Mobile phase preparation & usage Buffer, Filtration, Degassing Storage & usage Preparation for analysis Sample preparation & System suitability Resolution, peak symmetry, tailing, capacity factor, Adjustment allowed as per USP Column management Washing and change of mobile phase Analysis and integration Audit trail, data backup, Review and Documentation Problems and reporting Qualification and Calibration

George Pompidou. President of France 1969-1974 'There are three roads to ruin; women, gambling and technicians. ... 'The most pleasant is with women, the ...