Analysis and Testing - QP Module

Course overview

It has been recognised for many years that the sampling and testing of materials does not by itself assure product quality. Any testing performed must be part of a comprehensive Pharmaceutical Quality System, including QA and GMP, and it must be correctly implemented and controlled.

This module reviews the principal qualitative and quantitative analytical methods in common use, the principles of method selection and validation. It also includes, sampling plans, physical and organoleptic testing, stability testing and the significance of degradation, contamination and adulteration of pharmaceutical materials. Importantly, it also includes the interpretation of analytical data including non-conforming results and stresses the importance of how these need to be managed. All activities are discussed and explained within the confines of Good Quality Control Laboratory Practice and applicable regulatory guidelines.

This course includes the following topics/sessions :

Day 1 (Classroom course only)

• Practical Laboratory Session that covers Chromatography HPLC/IC, Microscopy and Oral Dosage forms (Dissolutions, Disintegration and Friability)

Day 1 (Online course or Day 2 Classroom Course)

• Basics of Analysis and Testing
• Physicochemical Methods
• Good Control Laboratory Practice
• Chromatography
• Incoming goods, sampling, In-process controls
• High Performance Liquid Chromatography (HPLC)

Day 2 Online course or Day 3 Classroom Course

• Other Instrumental Techniques
• Impurities, degradation, contamination, and adulteration
• Cleaning validation
• Specifications and Methods
• Analytical Method Validation
• OOS Investigations
• Stability Testing

Prerequisites

This module forms part of a series designed to satisfy the Study Guide requirements for those wishing to become a QP. It is also suitable for any analysts who ‘left the laboratory’ a long time ago and other production and QA professionals wishing to top up.