Risk assessment of hospital preparations according to the model proposed by the European Council Resolution CM / Res (2016) 1

6 October 2017

E.H. Diouf1, M. Raynaud1, D. Salmon1,2, C. Merienne1, D. Laleye1, C. Pivot1, F. Pirot1,2 1 Pharmacie, Hôpital Édouard Herriot HCL, Lyon France
2 Laboratoire de Pharmacie Galénique Industrielle, UMR 5305, Université Lyon 1 France


The objective of this work was to carry out an initial risk assessment of our sterile and non-sterile hospital preparations according to the resolution of the European Council CM / Res (2016) 1.


The methodology used was based on the risk assessment model (low or high) of Resolution CM / Res (2016) 1, taking into account the type of preparation, the number of units per batch, the pharmacological effect, the preparation method and the delivery.
Each risk criterion corresponded to a risk factor ranging from 1 to 5. The number obtained by multiplying these risk factors indicated the level of the quality system required for the pharmaceutical preparation process. The analysis was carried out on five examples of preparations representative of our activity with the large sterile preparations processes and a non-sterile process (capsules).


Table 1: Risk assessment of hospital preparations


This analysis determined the level of the quality system that should be applied. Preparation was considered "high risk" if the number was greater than 100 (GMP) and "low risk" if the number was less than or equal to 100 (BPP, French good manufactured practice).
Sterile preparations will be considered "high risk" except for the non-injectable solution, manufactured in very small quantities and administered in internal use of the institution. Table 1 showed that a non-sterile initially considered a "low risk" could become a "high risk" if the quantities prepared was important and delivered to other healthcare institutions.

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