title: [Pharmaceutical involvement in academic clinical trials: Quality assessment of pharmaceutical manufacturing operations].
abstract: BACKGROUND
  For academic clinical trials, the hospital pharmacy may be required to perform the specific activity of preparing investigational drugs.
  
  
  METHODS
  With regards to such activity, and in light of the recent changes in the regulatory environment, the main objective of this study was to evaluate whether quality levels and traceability were in compliance with the applicable regulatory standards. In order to do so, two internal audits have been conducted, the first on the compliance of operations with existing regulatory standards and the second on the quality of traceability of the operations.
  
  
  RESULTS
  The proportion of academic clinical trials is constantly growing and currently represents 41% of the total clinical trials in the establishment. An average of 29,000 therapeutic units of investigational drugs are prepared each year (84% under the form of capsules). An overall conformity level of 75% and 88% has been identified in the aforementioned audits, respectively. Such audits have also allowed for the identification of weaknesses in current practices as well as potential improvement areas to achieve better compliance.
  
  
  CONCLUSIONS
  The hospital pharmacy can provide expertise for the preparation of specific dosage or drugs that are not available on the market. It also can be involved for the conception of appropriated packaging function of the study design.
  
  
  CONCLUSIONS
  Results of audits encourage us to continue this activity with a satisfactory level of quality in accordance with the necessary requirements to ensure the safety of patients and the quality of clinical trials conducted.
authors.affiliation: Service pharmaceutique, groupement hospitalier Edouard-Herriot, 5, place d'Arsonval, 69437 Lyon cedex 03, France. Electronic address: cecile.gerard@calydial.org.
authors.forename: C
authors.initials: C
authors.lastname: Gérard
authors.affiliation: Service pharmaceutique, groupement hospitalier Edouard-Herriot, 5, place d'Arsonval, 69437 Lyon cedex 03, France.
authors.forename: M L
authors.initials: ML
authors.lastname: Tall
authors.affiliation: Service pharmaceutique, groupement hospitalier Edouard-Herriot, 5, place d'Arsonval, 69437 Lyon cedex 03, France.
authors.forename: E Boidi Trotti
authors.initials: EB
authors.lastname: Reymond
authors.affiliation: Service pharmaceutique, groupement hospitalier Edouard-Herriot, 5, place d'Arsonval, 69437 Lyon cedex 03, France.
authors.forename: D
authors.initials: D
authors.lastname: Laleye
authors.affiliation: Service pharmaceutique, groupement hospitalier Edouard-Herriot, 5, place d'Arsonval, 69437 Lyon cedex 03, France.
authors.forename: E
authors.initials: E
authors.lastname: Hutasse
authors.affiliation: Service pharmaceutique, groupement hospitalier Edouard-Herriot, 5, place d'Arsonval, 69437 Lyon cedex 03, France.
authors.forename: A-C
authors.initials: AC
authors.lastname: Retière
authors.affiliation: Service pharmaceutique, groupement hospitalier Edouard-Herriot, 5, place d'Arsonval, 69437 Lyon cedex 03, France.
authors.forename: C
authors.initials: C
authors.lastname: Dhelens
authors.affiliation: Service pharmaceutique, groupement hospitalier Edouard-Herriot, 5, place d'Arsonval, 69437 Lyon cedex 03, France; Laboratoire de recherche et développement de pharmacie galénique industrielle, faculté de pharmacie, EA 4169 « fonctions physiologiques et pathologiques de la barrière cutanée », université Claude-Bernard Lyon 1, 8, avenue Rockefeller, 69373 Lyon cedex 08, France.
authors.forename: F
authors.initials: F
authors.lastname: Pirot
authors.affiliation: Service pharmaceutique, groupement hospitalier Edouard-Herriot, 5, place d'Arsonval, 69437 Lyon cedex 03, France.
authors.forename: C
authors.initials: C
authors.lastname: Pivot
mesh_terms: D002986:Clinical Trials as Topic / Q000592:standards / Q000706:statistics & numerical data*; D004345:Drug Industry / Q000592:standards / Q000706:statistics & numerical data*; D015507:Drugs, Investigational; D006801:Humans; D011786:Quality Control
chemical_list: D015507:Drugs, Investigational
keywords: Audit interne; Clinical trial; Essai clinique; Internal audit; Investigational drug; Médicament expérimental; Pharmaceutical preparation; Préparation pharmaceutique; Quality assessment; Qualité