Abstract

The suitability of good manufacturing practice (GMP) for the quality assurance of the preparation in hospital pharmacies is investigated. It is expected that the recent expansion of GMP with quality by design (QbD) and quality risk management (QRM) will significantly improve the applicability for all types of preparation in hospital pharmacies. QbD and QRM acknowledge the importance of targeting the need of the patient, of a good design and of risk assessment, thereby offering more flexibility to the hospital pharmacist to respond to everyday requests for patient care.

For European hospital pharmacy an elaboration of GMP principles for specific preparation processes is desirable. The development of models for risk assessment will also be very helpful. The usefulness of the Council of Europe Resolution for these aims is discussed. This article aims to provide a small contribution towards a transparent, predictable though flexible and cost-effective pharmacy preparation.