Amsavel PowerPoint PPT Presentations

Requirement Deviation, OOS and reporting Investigation RCA Investigative tools: Why –Why , Cause & Effect and FTA Human error CAPA Implementation Investigation report Verification for effectiveness

Introduction Titration Basics Reaction, End point & Indicators Types of Titrations Acid – Base Theory & Principles Acid Base titration Non- Aqueous Titration Precipitation Titration Complexometric Titration Oxidation- Reduction Titration Calculation General Information Errors

Problem Solving Steps Statistical Tools Run Chart Pareto Chart Cause and Effect diagram- Fishbone Diagram Brainstorming Histograms or Stem-and-Leaf Plot Control Chart Process Capability,

Significance of balances in the QC Laboratories Types of Balances Definition Minimum weight Location for installation Balances USP requirement Performances test Calibration Repeatability Linearity Eccentricity Sensitivity Factor influence the accuracy of weight Types of samples and handling Precaution to be taken while weighing

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

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

Annual Product Quality Review (APQR) Guidelines / Requirement Responsibility Procedure Documents and Data Required Check list Preparation, evaluation and documentation Eg. Trend Charts, process capability Recommendation and Conclusion

Basic’s of Contamination Sources of Contamination Environment Specification Elements of Cleanroom Design and Qualification Definitions Control of Contaminations People, Cleaning, Environment & Material Operation, Monitoring and Control Documents and Records

Objective of Data Integrity What is Data Integrity? Regulatory Requirement Data Integrity Principles ALCOA, + Principles Basic Data Integrity Expectations Data Integrity examples and WL Implementation

Reference Guideline Definitions GMP Requirement: 21 CFR § 211.198 and ICH Q7 Procedure for Handling of Complaints Complaint Investigation Remedial action and CAPA Report preparation Response to customer Verification of CAPA effectiveness Review of Complaints