Elaboración del manual de buenas prácticas de manufactura en la empresa Polar Bear Pbec cia.ltda

Abstract

The Polar Bear Pbec Ltd. company, lacks Good Manufacturing Practices (GMP), leading to multiple vulnerabilities, such as the absence of process records, handling procedures, and non-compliance with current health regulations. For this reason, this research aimed to develop the Good Manufacturing Practices manual for Polar Bear Pbec Co. Ltd., located in the Salcedo canton of Cotopaxi province. The research methodology included a deductive method, establishing a general premise based on the necessity of fulfilling Good Manufacturing Practices (GMP) requirements to ensure product quality and safety. The resolution ARCSA-DE-2022-016-AKRG was the reference to create a checklist for the initial situational diagnosis of the company. The results were essential to establish an improvement plan to address non-conformities. Finally, the procedures and records for the GMP manual were designed. The company meets 56.35% of the requirements of resolution ARCSA-DE-2022-016-AKRG. Corrective actions were based on the initial diagnosis to reinforce safety and quality standards in the operational environment, including the hygiene and cleaning practices enhancements. The Good Manufacturing Practices manual contains Standard Operating Procedures (SOP) and Sanitation Standard Operating Procedures (SSOP). The Good Manufacturing Practices (GMP) manual ensures compliance with national health regulations, ensuring the quality and safety of frozen products.