[Criteria for management and use of instrumental techniques].
The measurement of various parameters--be it plain temperature readings or determination of pesticides, drug monitoring or measurement of contaminants in air or water--must be carried out precisely and accurately. After purchase of the instrument, the installation qualification and the operation qualification, both produced by experts in the manufacturing company, are used to ensure correct use of the instrument. The standard operating procedures for instrument management must be sufficiently detailed to allow the operator to use the instrument correctly and, above all, must contain all the information necessary for accurate and precise calibrations. From 2002, the Food and Drug Administration will no longer accept submission of paper dossiers, so that pharmaceutical companies wishing to register a product in the USA will be obliged to submit the dossier electronically. This will involve the validation of all the software used in the management and operation of all instruments. It can be assumed that the EMEA will shortly follow the FDA, so that the validation of instrument software systems will become the rule and create new responsibilities for operators and inspectors.
Dipartimento di Farmacocinetica e Metabolismo, Menarini Ricerche SpA, Via Tito Speri 10, 00040 Pomezia, Roma. acrea@menarini-ricerche.it
Attilio E G
AE
Crea
D002138:Calibration / Q000592:standards; D002623:Chemistry Techniques, Analytical / Q000295:instrumentation / Q000592:standards; D002851:Chromatography, High Pressure Liquid / Q000295:instrumentation; D019411:Clinical Laboratory Techniques / Q000295:instrumentation / Q000592:standards*; D004282:Documentation; D004868:Equipment Failure; D004864:Equipment and Supplies / Q000592:standards*; D005568:Forms and Records Control / Q000331:legislation & jurisprudence / Q000592:standards; D006077:Government Agencies / Q000592:standards; D007558:Italy; D013058:Mass Spectrometry / Q000295:instrumentation; D012015:Reference Standards; D015203:Reproducibility of Results; D012106:Research / Q000331:legislation & jurisprudence / Q000592:standards*; D012107:Research Design; D012984:Software / Q000592:standards; D013672:Technology / Q000331:legislation & jurisprudence / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration