Article Abstract

Role of the quality assurance person in the production of recovered plasma for fractionation

Authors: Shun-Chung Pai

Abstract

The collection of plasma for clinical use and fractionation is a logistically and technically complex process as to the need for ensuring product quality, safety, and efficacy. Many blood establishments (BEs) have introduced Good Manufacturing Practice (GMP) based quality system to maintain high quality and safety of plasma. However, the implementations of comprehensive quality system need some skillful professionals to work on the quality assurance (QA) issues. QA person has a critical role in quality system development, implementation, maintaining and improvement. They can be described as a supervisor or coordinator through using process approach tools and risk-based thinking for all QA activities. Although the scope of the duties covered by QA person is dictated by the size of establishments, they share some basic responsibilities including documentation management, equipment qualification, process validation, change control, plasma batch release, deviations management, recall procedure, audit management, and process improvement. This article briefly discusses the role and skills of QA person in BEs and shares our experience of some QA activities in supplying recovered plasma for fractionation.