Development of Good Manufacturing Practices System for enteral food and its application at Gatot Soebroto Hospital Jakarta

Abstract

Hospital formula enteral food is a ready to eat (RTE) food categorized as a special food because it is targeted specifically for group of people with health risk. Therefore, the safety of this enteral food needs to be controlled more stringenly than other RTE food. One of the basic food safety management that can be applied is GMP (Good Manufacturing Practices). Presently guidelines for good processing method for enteral food is not available yet. This research was aimed to develop a GMP system for enteral food or CPMEB (Cara Produksi Makanan Enteral yang Baik) consisting a guideline as well as the auditing system, and its application in Gatot Soebroto Hospital Jakarta. The system was development based on the Indonesian Health Ministry Regulation Number: 1096/MenKes/PER/VI/2011 on hygiene and food services sanitation; The National Agency of Drug and Food Control Regulation2011 Number: HK.03.1.23.12.11.10720 on the guidelines for the production of processed food products for baby powder formula and advanced powder formula; The National Agency of Drug and Food Control Decree2003 Number: HK. 00.05.5.1639 on the guidelines for food production for home industry; and other relevant references. Based on the literature review and trials, the CPMEB guideline and its audit system applicable to the enteral production unit of the hospital were developed. Thirteen aspects were defined for the requirements; including four main aspects. The main aspects were criteria with higher priority. The aspects belong to this group were the production room, production equipment, process control and workers' hygiene. The rest of the aspects include building and its facilities, sanitation facility, raw materials storage, monitoring management, pest control, enteral food distribution, training, and patient feeding. The trial at Gatot Soebroto hospital shows that the enteral food production unit can be categorized as good; with improvements needed for several aspects such as: production equipment storage, hygiene and sanitation maintenance, blender handling sanitation procedure, process control for type of container, volume of container, production notes, enteral food storage, food distribution and training.