GMP in donor centres

Abstract

Background: Collection and production of blood components should be in line with current blood guidelines to ensure both donor safety and the quality of the blood product. Guidelines were developed for the whole process of blood collection and processing as well as for apheresis procedures. Implementation of such Good Manufacturing Practice (GMP) is mandatory for donor centres.

Design: Principles of GMP and its impact on quality management for the donor centre are reviewed in the present paper. Relevant GMP chapters and practical issues show how to manage GMP.

Results: The European GMP guideline helps to standardize the production of medicinal products. Requirements for quality control and management, documentation and manufacturing are described in GMP guidelines. Risk management helps to identify and quantify failures in the production process.

Conclusion: Implementation of GMP ensures donor and product safety.

Keywords: Donor centre; Good manufacturing practice; Quality; Quality management.