Harmonization of strategies for the validation of quantitative analytical procedures. A SFSTP proposal--part II.
As reported in a previous paper, the main objective of the new commission of the Société Française des Sciences et Techniques Pharmaceutiques (SFSTP) was the harmonisation of approaches for the validation of quantitative analytical procedures. In a series of meetings, members of this Commission have first tried to review the objectives of analytical methods and the objectives of validation methods and to recommend the use of two-sided beta-expectation tolerance intervals for total error of validation samples (accuracy profile) in the acceptance/rejection of analytical method in validation phase. In the context of the harmonization, the other objectives were: (i) to propose a consensus on the norms usually recognized, while widely incorporating the ISO terminology; (ii) to recommend to validate the analytical procedure accordingly to the way it will be used in routine; (iii) to elaborate a rational, practical and statistically reliable strategy to assure the quality of the analytical results generated. This strategy has been formalised in a guide and the three latter objectives made by the Commission are summarised in the present paper which is the second part of summary report of the SFSTP commission. The SFSTP guide has been produced to help analysts to validate their analytical methods. It is the result of a consensus between professionals having expertise in analytical and/or statistical fields. The suggestions presented in this paper should therefore help the analyst to design and perform the minimum number validation experiments needed to obtain all the required information to establish and demonstrate the reliability of its analytical procedure.
Hubert
Ph
P
Laboratory of Analytical Chemistry, Bioanalytical Chemistry Research Unit, Institute of Pharmacy, University of Liège, CHU, B36, B-4000 Liège, Belgium. Electronic address: ph.Hubert@ulg.ac.be.
Nguyen-Huu
J-J
JJ
Sanofi-Aventis, quai Jules Guesde, B.P. 14, F-94403 Vitry sur Seine, France.
Boulanger
B
B
UCB Pharma SA, Chemin du Foriest, B-1420 Braine-L'alleud, Belgium.
Chapuzet
E
E
Qualilab, rue de la Bergeresse, F-45160 Olivet (Orléans), France.
Chiap
P
P
Advanced Technology Corporation (A.T.C.), Institute of Pathology B23, University Hospital Center of Liège, B-4000 Liège 1, Belgium.
Cohen
N
N
Expanscience, rue des quatre Filles B.P. 25034, F-28231 Epernon, France.
Compagnon
P-A
PA
French Agency for Health Products Safety (AFSSAPS), Boulevard Anatole France, Les Portes de Pleyel, F-93285 St. Denis, France.
Dewé
W
W
GlaxoSmithKline Biologicals, 89, Rue de l'Institut, B-1330 Rixensart, Belgium.
Feinberg
M
M
National Institute for Agricultural Research (INRA), rue Claude Bernard, F-75231 Paris, France.
Lallier
M
M
Innothera, Avenue Paul Vaillant Couturier, F-94110 Arcueil, France.
Laurentie
M
M
LERMDV, French Food Safety Agency (AFSSA), B.P. 90203, F-35032 Fougères, France.
Mercier
N
N
Qualilab, rue de la Bergeresse, F-45160 Olivet (Orléans), France.
Muzard
G
G
Merck-Theramex, Avenue Prince Héréditaire Albert, F-98007 Monaco, France.
Nivet
C
C
CERB, Chemin de Montifault, F-18800 Baugy, France.
Valat
L
L
Viatris-Manufacturing, Avenue J.F. Kennedy, B.P. 100, F-33701 Mérignac, France.
Rozet
E
E
Laboratory of Analytical Chemistry, Bioanalytical Chemistry Research Unit, Institute of Pharmacy, University of Liège, CHU, B36, B-4000 Liège, Belgium.
D002138:Calibration; D002623:Chemistry Techniques, Analytical / Q000379:methods / Q000592:standards; D002626:Chemistry, Pharmaceutical / Q000379:methods / Q000592:standards; D019411:Clinical Laboratory Techniques / Q000379:methods / Q000592:standards; D005602:France; D012015:Reference Standards; D015203:Reproducibility of Results; D012955:Societies, Medical