title: Approach to design space from retrospective quality data.
abstract: BACKGROUND
  Nowadays, the entire manufacturing process is based on the current GMPs, which emphasize the reproducibility of the process, and companies have a lot of recorded data about their processes.
  
  
  OBJECTIVE
  The establishment of the design space (DS) from retrospective data for a wet compression process.
  
  
  METHODS
  A design of experiments (DoE) with historical data from 4 years of industrial production has been carried out using the experimental factors as the results of the previous risk analysis and eight key parameters (quality specifications) that encompassed process and quality control data.
  
  
  RESULTS
  Software Statgraphics 5.0 was applied, and data were processed to obtain eight DS as well as their safe and working ranges.
  
  
  CONCLUSIONS
  Experience shows that it is possible to determine DS retrospectively, being the greatest difficulty in handling and processing of high amounts of data; however, the practicality of this study is very interesting as it let have the DS with minimal investment in experiments since actual production batch data are processed statistically.
authors.affiliation: a Rovi Contract Manufacturing , Madrid , Spain .|b Pharmacy and Pharmaceutical Technology Department, Faculty of Pharmacy , University of Barcelona , Barcelona , Spain , and.
authors.forename: Daniel
authors.initials: D
authors.lastname: Puñal Peces
authors.affiliation: b Pharmacy and Pharmaceutical Technology Department, Faculty of Pharmacy , University of Barcelona , Barcelona , Spain , and.
authors.forename: Encarna
authors.initials: E
authors.lastname: García-Montoya
authors.affiliation: c Statistic Department , Centro Superior de Investigaciones Científicas (CSIC) , Barcelona , Spain.
authors.forename: Albert
authors.initials: A
authors.lastname: Manich
authors.affiliation: b Pharmacy and Pharmaceutical Technology Department, Faculty of Pharmacy , University of Barcelona , Barcelona , Spain , and.
authors.forename: Josep Maria
authors.initials: JM
authors.lastname: Suñé-Negre
authors.affiliation: b Pharmacy and Pharmaceutical Technology Department, Faculty of Pharmacy , University of Barcelona , Barcelona , Spain , and.
authors.forename: Pilar
authors.initials: P
authors.lastname: Pérez-Lozano
authors.affiliation: b Pharmacy and Pharmaceutical Technology Department, Faculty of Pharmacy , University of Barcelona , Barcelona , Spain , and.
authors.forename: Montse
authors.initials: M
authors.lastname: Miñarro
authors.affiliation: b Pharmacy and Pharmaceutical Technology Department, Faculty of Pharmacy , University of Barcelona , Barcelona , Spain , and.
authors.forename: Josep Ramon
authors.initials: JR
authors.lastname: Ticó
mesh_terms: D002626:Chemistry, Pharmaceutical / Q000379:methods* / Q000592:standards*; D011786:Quality Control; D012189:Retrospective Studies; D012984:Software / Q000592:standards*
keywords: ICH Q8; ICH Q9; optimization; quality control attributes; quality risk