Perumusan Corrective Action and Preventive Action (CAPA) pada Salah Satu Pedagang Besar Farmasi di Kota Bandung

Ella Fazila; Norisca Aliza Putriana

doi:10.61132/obat.v3i1.1030

Authors

Ella Fazila Universitas Padjadjaran
Norisca Aliza Putriana Universitas Padjadjaran

DOI:

https://doi.org/10.61132/obat.v3i1.1030

Keywords:

PBF, CAPA, CDOB

Abstract

Pharmaceutical Wholesalers or commonly known as PBFs are companies in the form of legal entities that have permits to procure, store and distribute large quantities of pharmaceutical supplies in accordance with the provisions of applicable laws and regulations. PBF must implement a quality system that includes quality risk management principles. An effective quality management system must include a Corrective Action and Preventive Action (CAPA) process to address deviations and prevent the same problems from occurring again in the future. The research was carried out by reviewing cases found by the Center for Food and Drug Monitoring (BBPOM) at PBF "X" and then continuing with an analysis of corrective actions and corrective actions that needed to be taken to overcome these cases of deviation. The results of the research show that the preparation of the CAPA by PBF PBF “X” has implemented most of the provisions contained in the CDOB guidelines well.

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