Multivariate statistical process control in annual pharmaceutical product review
| Autor: | Adamastor R. Tôrres, Antônio Diógenes P. de Oliveira, Severino Grangeiro Júnior, Wallace D. Fragoso |
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| Rok vydání: | 2018 |
| Předmět: |
Process (engineering)
business.industry Computer science media_common.quotation_subject 010401 analytical chemistry Harmonization 02 engineering and technology 021001 nanoscience & nanotechnology 01 natural sciences Industrial and Manufacturing Engineering Manufacturing engineering 0104 chemical sciences Computer Science Applications Multivariate statistical process control Quality management system Product reviews Control and Systems Engineering Modeling and Simulation Quality (business) Product (category theory) 0210 nano-technology business media_common Pharmaceutical industry |
| Zdroj: | Journal of Process Control. 69:97-102 |
| ISSN: | 0959-1524 |
| Popis: | Annual Product Review recommending by the Food and Drug Administration and the International Conference on Harmonization is a periodic assessment of products quality to verifying the consistency of the production process and the quality of the finished product. In this work it was performed an annual product review using multivariate statistical process control. Multivariate control charts was used for the periodic evaluation of the Hydrochlorothiazide 25 mg tablet, produced between 2009 and 2013 in the Pharmaceutical Laboratory of Pernambuco (Brazil). The procedure has allowed one to monitor and diagnose deviations in the production process. A corrective action was taken in the process by the Quality System in 2011 and the methodology applied was used to evaluate this action’s effectiveness. Through the Multivariate Statistical Process Control it was possible to make an annual product review in accordance with the pharmaceutical industry regulatory requirements. |
| Databáze: | OpenAIRE |
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