Adaptação e aplicação das diretrizes de revisão periódica de produtos para farmácia de manipulação

Abstract

The Periodic Product Review (PPR) is a Quality Assurance tool used by the world's leading regulatory entities. The RPP, a term accepted by ANVISA, has been recommended since 2006 in Brazil through the “Guides Related to Quality Assurance”. In 2010, the use of this tool became mandatory in Brazil, from the implementation of the RDC 17 of 2010 (BRAZIL, 2010) and it’s obligation remains with RDC nº 301 de 2019. For the development of this project, the Pharmacy School was used for data collection and implementation of the PPR and the study was conducted retrospectively from 2015 to 2018. The following parameters were established for the RPP: evaluation of drug analysis certificate as the pH, volume, density and assay for the cumaru syrup, and the determination of weight, assay and unit dose uniformity for 500 mg + Vit.D 400 UI calcium carbonate capsules;Thus, considering the importance and the advantages in the execution of the RPP mainly in what regards the evaluation of the process stability, and since there is no similar tool capable of monitoring the productive process in handling pharmacy, it was decided to adapt and apply the RPP as a process monitoring model in the pharmacies. Thus, by adapting and applying the RPP, the objectives are to verify the consistency of the productive process that is under review, to determine if there is any need of making changes in the productive process and to identify improvements in the product and the process. Visits were made to the Pharmacy School to collect information about its productive process. The drug analysis certificates were assessed for cumaru syrup and 500mg + Vit.D 400 UI calcium carbonate capsules; complaints, returns and recalls concerning; the analysis certificate of suppliers used in the same period for the production of the assessed products and the validation of the analytical methodologies used. Thus, it was possible to evaluate that the production process of cumaru syrup and calcium carbonate capsules is unstable and under the influence of several variables. In addition, suppliers are GMP compliant, according to RDC No. 67/2007, have no complaints during 2015-2018 and use pharmacopoeial analytical methods to measure calcium carbonate in 500 mg + Vit calcium carbonate capsules. .D 400 IU is a locally developed methodology for the measurement of coumarins in cumaru syrup. Thus, it was possible to adapt and apply the tool to the Pharmacy Manipulation, as well as identify improvements in the process.