Guide to good metrology practices

Citation
A. Potier et al., Guide to good metrology practices, STP PHARM S, 9(2), 1999, pp. 141-159
Citations number
38
Categorie Soggetti
Pharmacology & Toxicology
Journal title
STP PHARMA SCIENCES
ISSN journal
11571489 → ACNP
Volume
9
Issue
2
Year of publication
1999
Pages
141 - 159
Database
ISI
SICI code
1157-1489(199903/04)9:2<141:GTGMP>2.0.ZU;2-Z
Abstract
Good metrology practices should be set up and applied in pharmaceutical com panies and related sectors in order to guarantee the reliability and precis ion of measures in product development, production and control. This guide reviews the elements that should be taken into consideration in metrology I t suggests what documents should be established and the associated responsi bilities, from the definition of technical needs to the management of sub-c ontracted companies and non-conformities, the establishment of a project pl an, the calculation of uncertainties and how to use them, organisational an d operational procedures of standardization and vertfication, registry docu ments and control cards, and personnel qualification.