Quality Management Fundamentals eBook

Training outcome of the module:

The two main components of a quality management system are quality assurance and quality control.

The basic concepts of quality assurance (QA), GMP, and quality control (QC) are interrelated. The sum of all these entities together comprises the pharmaceutical quality system (PQS). The functions or roles of QA, GMP, and QC are collectively critical to the effective and safe production and control of medicinal products.

On completion of this module, you will be able to:

– Recognize how attention to manufacturing a quality product reflects on the day-to-day operations.

– Identify the role of Quality Assurance in pharmaceutical manufacturing.

– Recognize how companies use GMP rules to minimize errors in manufacturing.

– Identify the main roles and responsibilities of quality control.

– Recognize the key elements of a pharmaceutical quality system.