Introduction to Pharmaceutical Quality

The idea that final testing of pharmaceutical products does anything with regards to ensuring quality has long been exposed as a lie. Quality has been defined in numerous ways, however, a definition that captures adequately what it means in the pharmaceutical industry is the fitness for use. This goal can only be achieved by building quality into the end product through every process in its actualization. This goes as far back as sourcing for good quality raw materials, subjecting systems and equipment to routine evaluations, and improving the manufacturing process while taking into consideration feedback from these evaluations and final consumers. This course introduces students to the concepts of the Quality Management System and Total Quality Management. You will also be introduced to the role of ICH guidelines in achieving quality the process way.

In this course, we provide a synthesis of the topic through an interactive online experience. This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.

Curriculum

Landing Page

Lesson 1: Pharmaceutical Quality

• The Concept of Quality
• What is Quality Control (QC)?
• What is in-Process Quality Control (IPQC)?
• What is Quality Assurance?
• Comparison of QA and QC

Lesson 2: Quality Management System (QMS)

• Objective of Quality Management
• Quality Management System
• Application of Quality Management System to cGMP
• Part A: Management Responsibilities
• Part B: Resource
• Part C: Manufacturing Operations
• Part D: Evaluation Activities

Lesson 3: Total Quality Management (TQM)

• Common Mistakes and Barriers in the Implementation of TQM
• 6Cs for Implementation of TQM
• TQM Methods and Tools

Lesson 4: Quality Manual and Quality Policy

• The Purpose of Quality Manual
• Structure and Format of the Quality Manual
• Quality Policy

Lesson 5: Understanding Pharmaceutical Quality by Design

• What is Quality by Testing?
• What is Quality by Design (QbD)?
• Objectives of Pharmaceutical Quality by Design
• Elements of QbD
• Quality Target Product (QTPP) That Identifies the Critical Quality Attributes (CQA) of the Drug Product
• Product Design and Understanding
• Process Design and Understanding
• Control Strategy
• Process Capability and Continual Improvement
• Four Tools of QbD
• Tool 1: Prior Knowledge
• Tool 2: Risk Assessment
• Tool 3: Mechanistic Model, Design of Experiments (DoE), and Data Analysis
• Tool 4: Process Analytical Technology

Lesson 6: ICH Guidelines

• Introduction
• List of ICH Guidelines

Glossary

Quiz