Pharmaceutical industrial equipment qualification in Brazil: a strategic test proposal for vaccine secondary material pa
- PDF / 1,908,941 Bytes
- 14 Pages / 595.276 x 790.866 pts Page_size
- 19 Downloads / 193 Views
ORIGINAL PAPER
Pharmaceutical industrial equipment qualification in Brazil: a strategic test proposal for vaccine secondary material packaging lines Thiago Jorge Teixeira Menezes 1
&
Carlos Francisco Simões Gomes 2
Received: 28 January 2020 / Accepted: 4 June 2020 # IUPESM and Springer-Verlag GmbH Germany, part of Springer Nature 2020
Abstract This research has as main objective prepare a qualification plan for vaccines secondary material packaging lines, in order to guide its practice and to define the tests required for the pharmaceutical industry in Brazil. This study sought to ensure product quality and health through better testing planning needed for proper installation, operation and performance of the equipment, as the few existing national regulations are generic regarding this type of approach. For this, a literature review was conducted using the most comprehensive research bases of scientific articles to describe the state of the art on the subject. The survey questionnaire was applied to the qualification and validation specialists. The use of a statistical tooling helped in the process of identification of the tests which cannot be missed within a quality planning. It is expected that the result of this study, through the development of a qualification plan, will add safety, reproducibility and effectiveness to the quality of the product and facilitate regulatory compliance with regulatory agencies. In addition, this plan will aim to contribute to other equipment and systems aimed at guiding specialists in qualification activities and the advancement of literature research. Keywords Equipment qualification . Health and quality management . Pharmaceutical industry
Abbreviations ANVISA National Health Surveillance Agency CAPES Higher Education Personnel Improvement Coordination CEIS Industrial Health Economic Complex CSV Computerized System Validation EMA European Medicine Agency FDA Food and Drug Administration HRA Health Regulatory Agency Electronic supplementary material The online version of this article (https://doi.org/10.1007/s12553-020-00447-0) contains supplementary material, which is available to authorized users. * Thiago Jorge Teixeira Menezes [email protected] Carlos Francisco Simões Gomes [email protected] 1
Quality Assurance Department, Fundação Oswaldo Cruz FIOCRUZ/ Bio-Manguinhos, Rio de Janeiro, RJ, Brazil
2
Engineering Department, Universidade Federal Fluminense – UFF, Niterói, RJ, Brazil
IQ MHRA NIBP OQ PQ RJ SP
Installation Qualification Medicines and Health Products Regulatory Agency National Program for Immunization Operational Qualification Performance Qualification Rio de Janeiro São Paulo
1 Introduction The pharmaceutical industry represents one of the most important economic and social sectors worldwide. Due to its responsibility in the production of vaccines and other health products, research, development, innovation and production activities have become an integral part of this sector. In Brazil, the pharmaceutical industrial sector is an integral part o
Data Loading...
