Statistical Considerations in Setting Specifications

Statistical concepts employed in setting specifications and their relationship to product quality control include accidental and systemic errors, frequency distributions, measures of dispersion, standard deviations, standard errors, and sampling plans. In summary, specifications must be set by taking into account [Pg.412]

Specifications for new drug substances and products Chemical substances. ICH Guideline Q6A. ICH Secretariat, c/o International Federation of Pharmaceutical Manufacturers Associations, 30 Rue de St-Jean, PO Box 9, 1211 Geneva 18, Switzerland. [Pg.412]

Specifications Test procedures and acceptance criteria for biotechnological/biological products. ICH Guideline Q6B. Details as in reference 1. [Pg.412]